Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans (DGA4ME)

September 11, 2023 updated by: USDA, Western Human Nutrition Research Center
This study, at the Western Human Nutrition Research Center (WHNRC), will focus on whether or not achieving and maintaining a healthy body weight is the most important health promoting recommendation of the Dietary Guidelines for Americans (DGA).The investigators hypothesize that improvement in cardiometabolic risk factors resulting from eating a DGA style diet will be greater in people whose energy intake is restricted to result in weight loss compared to those who maintain their weight. The investigators further propose that during a state of energy restriction, a higher nutrient quality diet such as the DGA style diet pattern, will result in greater improvement in cardiometabolic risk factors compared to a typical American diet (TAD) pattern that tends to be lower nutrient quality (more energy-dense and less nutrient-rich.)

Study Overview

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:

  1. DGA Mediterranean diet pattern at sufficient energy level to maintain body weight (energy balance)
  2. DGA Mediterranean diet pattern at a moderately reduced energy level (negative energy balance)
  3. 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

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Davis, California, United States, 95616
        • Recruiting
        • UC Davis, Western Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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
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).
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.

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
Body weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.
Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

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
Triglycerides will be measured in blood (mg/dL).
Baseline and 1, 2, 3, and 6 hours after a challenge meal
Change in ghrelin in response to a meal
Time Frame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
Ghrelin will be evaluated as an indicator of hunger signaling.
Baseline and 1, 2, 3, and 6 hours after a challenge meal
Change in leptin in response to a meal
Time Frame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
Leptin will be evaluated as an indicator of satiety signaling.
Baseline and 1, 2, 3, and 6 hours after a challenge meal
Change in insulin in response to a meal
Time Frame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
Insulin measured in blood using an antibody based assay. Will also be expressed as the quantitative insulin sensitivity check index (QUICKI).
Baseline and 1, 2, 3, and 6 hours after a challenge meal
Change in Matsuda Index
Time Frame: Baseline and 1, 2 hours after a challenge meal
Matsuda index will be calculated from plasma glucose and insulin.
Baseline and 1, 2 hours after a challenge meal
Change in post-prandial metabolic rate
Time Frame: 1, 2, 3 and 6 hours after a meal
Post-prandial metabolic rate measured using indirect calorimetry.
1, 2, 3 and 6 hours after a meal
Height
Time Frame: Week 1
Height will be measured to the nearest 0.1 cm using a wall-mounted stadiometer.
Week 1
Change in body mass index
Time Frame: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
Body weight and height will be used to calculate Body Mass Index (BMI) as kg/m2.
Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
Change in body water (via InBody)
Time Frame: Week 1, 10, 28
Measured using bioelectrical impedance analysis (BIA) with an InBody 770® expressed as kg.
Week 1, 10, 28
Change in body fat (via DEXA scan)
Time Frame: Week 1, 10, 28
Fat mass (grams) will be measured using dual energy x-ray absorptiometry (DEXA).
Week 1, 10, 28
Change in waist circumference
Time Frame: Week 1, 10, 28
Waist circumference is measured with an anthropometric tape. Measurements will be performed in duplicate and averages recorded to the nearest 0.1 cm.
Week 1, 10, 28
Change in hip circumference
Time Frame: Week 1, 10, 28
Hip circumference is measured with an anthropometric tape. Measurements will be performed in duplicate and averages recorded to the nearest 0.1 cm.
Week 1, 10, 28
Change in waist to hip ratio
Time Frame: Week 1, 10, 28
Waist and hip circumference will be expressed as a ratio.
Week 1, 10, 28
Change in resting systolic blood pressure
Time Frame: Week 1, 10, 28
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.
Week 1, 10, 28
Change in resting diastolic blood pressure
Time Frame: Week 1, 10, 28
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.
Week 1, 10, 28
Change in resting heart rate
Time Frame: Week 1, 10, 28
Resting heart rate (pulse) will obtained via automated instrument in beats per minute.
Week 1, 10, 28
Genetic Risk of Obesity
Time Frame: Week 1
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).
Week 1
Change in vascular health
Time Frame: Week 1, 5, 10
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.
Week 1, 5, 10
Change in liver fat
Time Frame: Week 1 and 10
Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®
Week 1 and 10
Change in liver stiffness
Time Frame: Week 1 and 10
Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®
Week 1 and 10
Change in blood metabolite profiles
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in fasting blood glucose
Time Frame: Week 1, 10, 28
This outcome will evaluate blood sugars levels in the fasted state.
Week 1, 10, 28
Change in hemoglobin A1C
Time Frame: Week 1, 10, 28
This outcome will evaluate glycated hemoglobin as a reflection of the plasma glucose level during the past two to three months.
Week 1, 10, 28
Change in urinary sodium
Time Frame: Week 1, 5, 7 and 10
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.
Week 1, 5, 7 and 10
Change in urinary potassium
Time Frame: Week 1, 5, 7 and 10
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.
Week 1, 5, 7 and 10
Change in urinary nitrogen
Time Frame: Week 1, 5, 7 and 10
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.
Week 1, 5, 7 and 10
Change in red blood cell fatty acids
Time Frame: Week 1, 10, 28
Red blood cell fatty acids will be analyzed by mass spectrometry (MS).
Week 1, 10, 28
Change in C-reactive protein
Time Frame: Week 1, 10, 28
C-Reactive Protein will be measured as a non-specific marker for inflammation.
Week 1, 10, 28
Change in carotenoid levels
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in total cholesterol
Time Frame: Week 1 and 10
Total cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).
Week 1 and 10
Change in high density lipoprotein (HDL) cholesterol
Time Frame: Week 1 and 10
HDL cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).
Week 1 and 10
Change in low density lipoprotein (LDL) cholesterol
Time Frame: Week 1 and 10
LDL cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).
Week 1 and 10
Change in resting metabolic rate
Time Frame: Week 1 and 10
Respiratory gas exchange measurements (oxygen consumption-VO2 and carbon dioxide production-VCO2) will be made to determine metabolic rate using a metabolic cart system.
Week 1 and 10
Change in metabolic flexibility
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in predicted VO2 max
Time Frame: Week 1, 10, 28
Cardiorespiratory endurance will be evaluated by measuring heart rate (HR) and oxygen consumption (VO2) during a walking graded exercise test on a treadmill.
Week 1, 10, 28
Change in interstitial glucose levels
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in executive function
Time Frame: Week 1 and 10
Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB).
Week 1 and 10
Change in response speed
Time Frame: Week 1 and 10
Assessed using Motor Screening Task (MOT), from Cambridge Neuropsychological Test Automated Battery (CANTAB).
Week 1 and 10
Change in verbal memory
Time Frame: Week 1 and 10
Assessed using Verbal Recognition Memory (VRM) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).
Week 1 and 10
Change in psycho-motor speed
Time Frame: Week 1 and 10
Assessed using Reaction Time (RTI) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).
Week 1 and 10
Change in spatial memory
Time Frame: Week 1 and 10
Assessed using Spatial Working Memory (SWM) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).
Week 1 and 10
Change in multitasking
Time Frame: Week 1 and 10
Assessed using Multitasking Test (MTT) from Cambridge Neuropsychological Test Automated Battery (CANTAB).
Week 1 and 10
Change in social cognition
Time Frame: Week 1 and 10
Assessed using Emotional Recognition (ERT) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).
Week 1 and 10
Change in attentive function
Time Frame: Week 1 and 10
Assessed using Stop Signal Task (STT) from Cambridge Neuropsychological Test Automated Battery (CANTAB).
Week 1 and 10
Change in allostatic load
Time Frame: Week 1, 10, 28
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.
Week 1, 10, 28
Change in continuous systolic blood pressure
Time Frame: Week 1 and 10
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg.
Week 1 and 10
Change in continuous diastolic blood pressure
Time Frame: Week 1 and 10
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg.
Week 1 and 10
Change in mean arterial blood pressure
Time Frame: Week 1 and 10
Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg .
Week 1 and 10
Change in mood
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in perceived stress
Time Frame: Week 1, 6, 10, 19 and 28
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.
Week 1, 6, 10, 19 and 28
Change in self-efficacy
Time Frame: Week 10, 19 and 28
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.
Week 10, 19 and 28
Change in diet satisfaction
Time Frame: Week 1, 19 and 28
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.
Week 1, 19 and 28
Change in appetite
Time Frame: Week 1 and 10
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.
Week 1 and 10
Three factor eating questionnaire
Time Frame: Week 1 and 10
This 18 item questionnaire is used to examine three dimensions of human eating behavior including cognitive restraint, disinhibition or uncontrolled eating and hunger.
Week 1 and 10
Barriers to physical activity
Time Frame: Week 1
Participants will be asked to complete the Barriers to Being Active questionnaire.
Week 1
Usual physical activity
Time Frame: Week 1
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.
Week 1
Diet acceptability
Time Frame: Week 10
This measurement is an evaluation of palatability, ease of preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed controlled feeding diet.
Week 10
Yale Food Addiction Scale
Time Frame: Week 1
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).
Week 1
Changes in dietary intake
Time Frame: Week 1, 19, and 28
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.
Week 1, 19, and 28
Change in stress reactivity
Time Frame: Week 1 and 10
Acute stress reactivity will be assessed by measuring salivary cortisol concentrations in response to a challenging task.
Week 1 and 10
Change in heart rate variability
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in Food Choice
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in oxygen consumption rate (OCR)
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in extracellular acidification rate (ECAR)
Time Frame: Week 1 and 10
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.
Week 1 and 10
Change in fecal microbiome
Time Frame: Week 1, 10 an 28
Assays will be performed on fecal samples to determine DNA representing the colonic microbiota.
Week 1, 10 an 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kevin D Laugero, PhD, USDA, Western Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized metabolomics data will be deposited on Metabolomics Work Bench (https://www.metabolomicsworkbench.org/), a national and international repository for metabolomics data and metadata, developed in support of the National Institutes of Health (NIH) Common Fund Metabolomics Program and housed at the San Diego Supercomputer Center (SDSC), University of California, San Diego. Archived data will include raw data files, quality assurance data, final analytical data, and associated experimental metadata including experimental group assignments, anthropometric, physiological and clinical measures.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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