- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04293224
Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans (DGA4ME)
Study Overview
Status
Conditions
Detailed Description
This will be a 28-week study including pre-diet testing (week 1), an 8-week controlled feeding period, post-diet testing (week 10), a follow-up period of dietary education and observation, and end of study testing (week 28). During the 8 week feeding, participants will be randomly assigned one of the following diets:
- DGA Mediterranean diet pattern at sufficient energy level to maintain body weight (energy balance)
- DGA Mediterranean diet pattern at a moderately reduced energy level (negative energy balance)
- TAD diet pattern at a moderately reduced energy level (negative energy balance)
In the follow-up phase, the investigators will evaluate how multiple factors may influence body weight management, including previous dietary exposure, as well as the role of cognitive function, executive function, genetics, habitual diet, physical activity, eating behavior, stress and stress responsivity, metabolic flexibility and gut microbiome.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ellen Bonnel, PhD
- Phone Number: 530-752-4184
- Email: ellen.bonnel@usda.gov
Study Contact Backup
- Name: Beverly Miller, BS, RDN
- Phone Number: 530-754-2541
- Email: bevmiller@ucdavis.edu
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Recruiting
- UC Davis, Western Human Nutrition Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Body Mass Index (BMI) 23-39.9 kg/m2 or 32-50% body fat percentage
- Willingness to have blood drawn
- The criteria listed above and at least one of the following: Fasting glucose ≥100 mg/dL but <126 mg/dL or Fasting triglyceride ≥125 mg/dL or HDL-cholesterol ≤50 mg/dL or Blood Pressure (BP): Systolic BP ≥130 mmHg or Diastolic BP ≥85 mmHg or Hemoglobin A1C ≥ 5.7 and <6.5%
Exclusion Criteria:
- Active participation in another research study
- Tested positive for COVID-19 within the past 10 days
- Been in close contact with a COVID-19 positive person within the past 14 days
- Blood Pressure (BP): Systolic BP ≥140 mmHg or Diastolic BP ≥90 mmHg
- LDL cholesterol ≥190 mg/dL
- Triglycerides ≥500 mg/dL
- Current use of smoking or chewing tobacco, e-cigarettes, cigars, vaping, cannabis or other use of nicotine containing products (within the past 6 months)
- Current use of dietary supplements and/or unwillingness to cease intake of dietary supplements
- Vegan or vegetarian lifestyle or any other dietary restrictions that would interfere with consuming the intervention foods and beverages (including dietary intolerances, allergies and sensitivities)
- Unwillingness to consume intervention foods and beverages
- Engage in more than moderate drinking (> 1 drink serving per day) or binge drinking (4 drinks within two hours).
- Unwillingness to cease alcohol intake as required for specific duration of the study
- Excessive intake of caffeine containing products (excessive defined as ≥ 400 mg/day)
- Unwillingness to refrain from caffeine intake on lab visit days.
- Intentional weight change of ≥5% of body weight within 6 months of entry into the study
- Diagnosis of disordered eating or eating disorder
- Recent diagnosis of any of the following or measurement on screening lab tests: Anemia (hemoglobin <11.7 g/dL) or abnormal liver or thyroid function (defined as liver enzymes that are >200% of upper limit (ALT upper limit is 43 U/L or Aspartate transaminase (AST) upper limit is 54 U/L) and thyroid function tests: Thyroxine (T4, free) <0.56 or >1.64 ng/dL; Thyroid-stimulating hormone (TSH) <0.35 or >5.6 μIU/mL).
- History of any of the following: Gastric bypass surgery, inflammatory bowel disease (IBD) or other GI conditions that would interfere with consuming the intervention foods, active cancer in the past three years excluding squamous or basal cell carcinomas of the skin that have been handled medically by local excision and other serious medical conditions
- Recent dental work or have conditions of the oral cavity that would interfere with consuming the intervention foods and beverages
- Taking any medication in the class of antipsychotics
- Long term use of antibiotics
- Taking any over the counter or prescribed medication for any of the following: Elevated lipids, elevated glucose, high blood pressure, weight loss or conditions that require corticosteroids (e.g. asthma, arthritis or eczema).
- Are pregnant, planning to become pregnant within the duration of the study or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DGA Mediterranean diet pattern, energy balance
Diet plan focused on energy balance (meets calorie needs), emphasizes fruits, vegetables and whole grains and limits calories from added sugars and saturated fats and reduces sodium intake per Dietary Guidelines for Americans (DGA) recommendations.
|
Foods and beverages will be provided for participants for eight weeks.
During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations.
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Experimental: DGA Mediterranean diet pattern, negative energy balance
Negative energy balance (~25% calorie reduction compared to needs), emphasizes fruits, vegetables and whole grains and limits calories from added sugars and saturated fats and reduces sodium intake per Dietary Guidelines for Americans (DGA) recommendations.
|
Foods and beverages will be provided for participants for eight weeks.
During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations
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Experimental: TAD diet pattern
Typical American Diet (TAD) with negative energy balance (~25% calorie reduction compared to needs) which mimics intake of fruits, vegetables, whole grains, added sugars, saturated fats and sodium based on data from What We Eat in America (WWEIA).
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Foods and beverages will be provided for participants for eight weeks.
During the controlled feeding portion of the study the be based on evidence collected from What We Eat in America (WWEIA) data.
Based on this data the participants will be provided a diet that reflects American dietary trends.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body weight
Time Frame: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
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Body weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.
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Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in triglycerides in response to a meal
Time Frame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
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Triglycerides will be measured in blood (mg/dL).
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Baseline and 1, 2, 3, and 6 hours after a challenge meal
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Change in ghrelin in response to a meal
Time Frame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
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Ghrelin will be evaluated as an indicator of hunger signaling.
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Baseline and 1, 2, 3, and 6 hours after a challenge meal
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Change in leptin in response to a meal
Time Frame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
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Leptin will be evaluated as an indicator of satiety signaling.
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Baseline and 1, 2, 3, and 6 hours after a challenge meal
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Change in insulin in response to a meal
Time Frame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
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Insulin measured in blood using an antibody based assay.
Will also be expressed as the quantitative insulin sensitivity check index (QUICKI).
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Baseline and 1, 2, 3, and 6 hours after a challenge meal
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Change in Matsuda Index
Time Frame: Baseline and 1, 2 hours after a challenge meal
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Matsuda index will be calculated from plasma glucose and insulin.
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Baseline and 1, 2 hours after a challenge meal
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Change in post-prandial metabolic rate
Time Frame: 1, 2, 3 and 6 hours after a meal
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Post-prandial metabolic rate measured using indirect calorimetry.
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1, 2, 3 and 6 hours after a meal
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Height
Time Frame: Week 1
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Height will be measured to the nearest 0.1 cm using a wall-mounted stadiometer.
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Week 1
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Change in body mass index
Time Frame: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
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Body weight and height will be used to calculate Body Mass Index (BMI) as kg/m2.
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Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
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Change in body water (via InBody)
Time Frame: Week 1, 10, 28
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Measured using bioelectrical impedance analysis (BIA) with an InBody 770® expressed as kg.
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Week 1, 10, 28
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Change in body fat (via DEXA scan)
Time Frame: Week 1, 10, 28
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Fat mass (grams) will be measured using dual energy x-ray absorptiometry (DEXA).
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Week 1, 10, 28
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Change in waist circumference
Time Frame: Week 1, 10, 28
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Waist circumference is measured with an anthropometric tape.
Measurements will be performed in duplicate and averages recorded to the nearest 0.1 cm.
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Week 1, 10, 28
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Change in hip circumference
Time Frame: Week 1, 10, 28
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Hip circumference is measured with an anthropometric tape.
Measurements will be performed in duplicate and averages recorded to the nearest 0.1 cm.
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Week 1, 10, 28
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Change in waist to hip ratio
Time Frame: Week 1, 10, 28
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Waist and hip circumference will be expressed as a ratio.
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Week 1, 10, 28
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Change in resting systolic blood pressure
Time Frame: Week 1, 10, 28
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Blood pressure will obtained via automated instrument and blood pressure cuff.
At least two measurements will be made, expressed in mmHg, and the average value will be recorded.
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Week 1, 10, 28
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Change in resting diastolic blood pressure
Time Frame: Week 1, 10, 28
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Blood pressure will obtained via automated instrument and blood pressure cuff.
At least two measurements will be made, expressed in mmHg, and the average value will be recorded.
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Week 1, 10, 28
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Change in resting heart rate
Time Frame: Week 1, 10, 28
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Resting heart rate (pulse) will obtained via automated instrument in beats per minute.
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Week 1, 10, 28
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Genetic Risk of Obesity
Time Frame: Week 1
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Genomic DNA will be collected from white blood cells.
A polygenic risk score (PRS) indexing genetic predisposition to obesity using known obesity single nucleotide polymorphisms (SNPs).
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Week 1
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Change in vascular health
Time Frame: Week 1, 5, 10
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Peripheral Arterial Tone (PAT) technology will be used to measure vascular health.
The EndoPAT test is a non-invasive measurement of the overall health of the endothelium.
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Week 1, 5, 10
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Change in liver fat
Time Frame: Week 1 and 10
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Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®
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Week 1 and 10
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Change in liver stiffness
Time Frame: Week 1 and 10
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Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®
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Week 1 and 10
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Change in blood metabolite profiles
Time Frame: Week 1 and 10
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Analysis of metabolites, the small molecule substrates, intermediates and products of metabolism analyzed by mass spectrometry (MS).
Includes branched chain amino acids, 2 hydroxybutyric acid, acylcarnitines, saturated, monounsaturated and polyunsaturated non-esterified fatty acids, triglyceride species, phospholipid species, bile acids and steroid hormones.
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Week 1 and 10
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Change in fasting blood glucose
Time Frame: Week 1, 10, 28
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This outcome will evaluate blood sugars levels in the fasted state.
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Week 1, 10, 28
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Change in hemoglobin A1C
Time Frame: Week 1, 10, 28
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This outcome will evaluate glycated hemoglobin as a reflection of the plasma glucose level during the past two to three months.
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Week 1, 10, 28
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Change in urinary sodium
Time Frame: Week 1, 5, 7 and 10
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Urinary sodium will be measured as indicators of dietary compliance during the feeding intervention of the study.
All urine passed for a 24 hour period will be collected.
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Week 1, 5, 7 and 10
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Change in urinary potassium
Time Frame: Week 1, 5, 7 and 10
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Urinary potassium will be measured as indicators of dietary compliance during the feeding intervention of the study.
All urine passed for a 24 hour period will be collected.
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Week 1, 5, 7 and 10
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Change in urinary nitrogen
Time Frame: Week 1, 5, 7 and 10
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Urinary nitrogen will be measured as indicators of dietary compliance during the feeding intervention of the study.
All urine passed for a 24 hour period will be collected.
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Week 1, 5, 7 and 10
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Change in red blood cell fatty acids
Time Frame: Week 1, 10, 28
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Red blood cell fatty acids will be analyzed by mass spectrometry (MS).
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Week 1, 10, 28
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Change in C-reactive protein
Time Frame: Week 1, 10, 28
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C-Reactive Protein will be measured as a non-specific marker for inflammation.
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Week 1, 10, 28
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Change in carotenoid levels
Time Frame: Week 1 and 10
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Serum carotenoids, including vitamin A, alpha-carotene, and beta-carotene will be used to evaluate nutrient status and dietary intake of vegetables prior to feeding intervention and post feeding intervention.
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Week 1 and 10
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Change in total cholesterol
Time Frame: Week 1 and 10
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Total cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).
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Week 1 and 10
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Change in high density lipoprotein (HDL) cholesterol
Time Frame: Week 1 and 10
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HDL cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).
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Week 1 and 10
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Change in low density lipoprotein (LDL) cholesterol
Time Frame: Week 1 and 10
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LDL cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).
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Week 1 and 10
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Change in resting metabolic rate
Time Frame: Week 1 and 10
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Respiratory gas exchange measurements (oxygen consumption-VO2 and carbon dioxide production-VCO2) will be made to determine metabolic rate using a metabolic cart system.
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Week 1 and 10
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Change in metabolic flexibility
Time Frame: Week 1 and 10
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The formula is designed to deliver approximately 800 kcals total with 60% kcals from fat (approximately 55 g of fat), 25% kcals from carbohydrates, and 15% of kcals from protein.
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Week 1 and 10
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Change in predicted VO2 max
Time Frame: Week 1, 10, 28
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Cardiorespiratory endurance will be evaluated by measuring heart rate (HR) and oxygen consumption (VO2) during a walking graded exercise test on a treadmill.
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Week 1, 10, 28
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Change in interstitial glucose levels
Time Frame: Week 1 and 10
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A continuous glucose monitor (CGM) will be used to continuously assess interstitial glucose levels.
The Abbott Freestyle Libre Pro Sensor is inserted under the skin on the back of the arm.
The sensor will measure the interstitial glucose level every fifteen minutes.
Participants will wear the monitors for fourteen days.
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Week 1 and 10
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Change in executive function
Time Frame: Week 1 and 10
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Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB).
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Week 1 and 10
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Change in response speed
Time Frame: Week 1 and 10
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Assessed using Motor Screening Task (MOT), from Cambridge Neuropsychological Test Automated Battery (CANTAB).
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Week 1 and 10
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Change in verbal memory
Time Frame: Week 1 and 10
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Assessed using Verbal Recognition Memory (VRM) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).
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Week 1 and 10
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Change in psycho-motor speed
Time Frame: Week 1 and 10
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Assessed using Reaction Time (RTI) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).
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Week 1 and 10
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Change in spatial memory
Time Frame: Week 1 and 10
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Assessed using Spatial Working Memory (SWM) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).
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Week 1 and 10
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Change in multitasking
Time Frame: Week 1 and 10
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Assessed using Multitasking Test (MTT) from Cambridge Neuropsychological Test Automated Battery (CANTAB).
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Week 1 and 10
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Change in social cognition
Time Frame: Week 1 and 10
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Assessed using Emotional Recognition (ERT) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).
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Week 1 and 10
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Change in attentive function
Time Frame: Week 1 and 10
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Assessed using Stop Signal Task (STT) from Cambridge Neuropsychological Test Automated Battery (CANTAB).
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Week 1 and 10
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Change in allostatic load
Time Frame: Week 1, 10, 28
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Allostatic load (AL) is an aggregate value derived from several parameters that assess physiologic adaptive response to neural or neuroendocrine stressors.
The following measures are used to determine the AL score: Urinary cortisol and catecholamine levels, resting blood pressure, waist to hip ratio, blood levels of high sensitivity C-Reactive Protein, cholesterol, dehydroepiandrosterone sulfate and hemoglobin A1c, and urinary levels of epinephrine and norepinephrine.
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Week 1, 10, 28
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Change in continuous systolic blood pressure
Time Frame: Week 1 and 10
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Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg.
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Week 1 and 10
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Change in continuous diastolic blood pressure
Time Frame: Week 1 and 10
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Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg.
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Week 1 and 10
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Change in mean arterial blood pressure
Time Frame: Week 1 and 10
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Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg .
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Week 1 and 10
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Change in mood
Time Frame: Week 1 and 10
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Mood assessed using the Profile of Mood States (POMS).
Total Mood Disturbance (TMD) score is found from the difference between "negative" subscales - "positive" subscales.
Individual scores on the POMS range from -32 to 200 with higher scores indicating higher mood disturbance.
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Week 1 and 10
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Change in perceived stress
Time Frame: Week 1, 6, 10, 19 and 28
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Perceived stress measured using the Perceived stress scale (PSS).
Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Responses for individual questions are summed to a total score.
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Week 1, 6, 10, 19 and 28
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Change in self-efficacy
Time Frame: Week 10, 19 and 28
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This 20 item questionnaire is a measurement of the capacity to execute behaviors necessary to change their weight and begin to implement exercise in their lives regularly.
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Week 10, 19 and 28
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Change in diet satisfaction
Time Frame: Week 1, 19 and 28
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This 28 item questionnaire acts as a valid instrument for assessing diet satisfaction in the context of weight-management.
This measurement assesses diet satisfaction both within and outside the context of weight-loss treatment, as well as to assesses change in satisfaction as a result of treatment.
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Week 1, 19 and 28
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Change in appetite
Time Frame: Week 1 and 10
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A computer tablet with stylus will be used to assess hunger and appetite, defined as perceived hunger, fullness, desire to eat, prospective consumption and other measures of food craving and perceived hypoglycemia.
Questions will be presented one-by-one on the screen and participants will be asked to express their response using visual analog scales (VAS).
This measurement will be evaluated during the meal challenge assessment.
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Week 1 and 10
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Three factor eating questionnaire
Time Frame: Week 1 and 10
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This 18 item questionnaire is used to examine three dimensions of human eating behavior including cognitive restraint, disinhibition or uncontrolled eating and hunger.
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Week 1 and 10
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Barriers to physical activity
Time Frame: Week 1
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Participants will be asked to complete the Barriers to Being Active questionnaire.
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Week 1
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Usual physical activity
Time Frame: Week 1
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An accelerometer (Actical) will be continuously worn by participants during waking hours (excluding bathing and swimming) for a period of 7 days.The measure of usual physical activity is used to estimate total energy expenditure and energy requirements.
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Week 1
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Diet acceptability
Time Frame: Week 10
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This measurement is an evaluation of palatability, ease of preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed controlled feeding diet.
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Week 10
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Yale Food Addiction Scale
Time Frame: Week 1
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Measures markers of substance dependence with the consumption of high fat/high sugar foods.
This is a 25-item self-report measure that includes mixed response categories (dichotomous and Likert-type format).
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Week 1
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Changes in dietary intake
Time Frame: Week 1, 19, and 28
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Three non-consecutive twenty-four hour dietary recalls will be collected when subjects are self-selecting their 'usual' diets.
A three day average nutrient intake will be expressed.
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Week 1, 19, and 28
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Change in stress reactivity
Time Frame: Week 1 and 10
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Acute stress reactivity will be assessed by measuring salivary cortisol concentrations in response to a challenging task.
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Week 1 and 10
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Change in heart rate variability
Time Frame: Week 1 and 10
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Autonomic physiological functioning will be assessed using the MindWare Cardio/Galvanic Skin Response (GSR) system, a device that connects to the subject's torso with eight disposable electrodes and a heart rate monitor.
Emotional arousal via skin conductance, a form of electrodermal activity (EDA) is also measured.
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Week 1 and 10
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Change in Food Choice
Time Frame: Week 1 and 10
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Food choice computer-based tests from Leeds, United Kingdom, will be used to estimate explicit liking and implicit wanting for several different categories of foods.
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Week 1 and 10
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Change in oxygen consumption rate (OCR)
Time Frame: Week 1 and 10
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Measured in peripheral blood mononuclear cells by use of Seahorse XF Analyzer, a tool for measuring glycolysis and oxidative phosphorylation (through oxygen consumption) simultaneously in the same cells.
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Week 1 and 10
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Change in extracellular acidification rate (ECAR)
Time Frame: Week 1 and 10
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Measured in peripheral blood mononuclear cells by use of Seahorse XF Analyzer, a tool for measuring glycolysis and oxidative phosphorylation (through oxygen consumption) simultaneously in the same cells.
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Week 1 and 10
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Change in fecal microbiome
Time Frame: Week 1, 10 an 28
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Assays will be performed on fecal samples to determine DNA representing the colonic microbiota.
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Week 1, 10 an 28
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Collaborators and Investigators
Investigators
- Principal Investigator: Kevin D Laugero, PhD, USDA, Western Human Nutrition Research Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Cardiovascular Diseases
- Prehypertension
- Women
- Insulin Resistance
- Metabolic Syndrome
- Insulin Sensitivity
- Glucose Intolerance
- Executive Function
- Cognitive Function
- Mediterranean Diet
- Eating Behavior
- Gut Microbiome
- Metabolic flexibility
- Physiology
- PreDiabetes
- Cardiovascular Risk Factor
- Allostatic Load
- Waist to Hip Ratio
- Stress, Physiological
- Dietary Guidelines for Americans
- Physical Activity for Americans
- Controlled Feeding
- Metabolomic Profiling
- Genome Testing
- Hypertriglyceridemic
Additional Relevant MeSH Terms
Other Study ID Numbers
- FL111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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