Individual Metabolism and Physiology Signature Study (iMAPS)

To determine if consumption of different diet plans that both are nutritionally-adequate and provide energy to maintain body weight, alters fasting insulin concentrations, shifts other common clinical markers of metabolic disease risk, and affects metabolomic profiles that reflect glucose, lipid, and amino acid metabolism.

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance; Metabolic Syndrome X
• Intervention / Treatment: Other: DGA Diet Plan; Other: NHANES Diet Plan

Detailed Description

Western Human Nutrition Research Center (WHNRC) scientists have observed rapid and substantial improvements in metabolic health indices in non-diabetic obese persons who undergo a weight-maintenance diet including prepared meals that were aligned with current dietary recommendations, including those of the Institute of Medicine and the United States Department of Agriculture (USDA) and Department of Health and Human Services (DHHS) Dietary Guidelines for Americans. For instance, marked reductions and often normalization of hyperinsulinemia were observed within days of provision of a controlled nutrient-dense high quality diet, and LDL was reduced by 20-30% or more within 2 weeks or possibly earlier. This indicates that change in diet alone would benefit many at-risk persons with respect to normalizing metabolic parameters and disease risk markers. Yet, surprisingly little formal research has focused on how a high quality, weight maintaining diet impacts health over a short-term period in at-risk individuals. The overall objective of this study is to determine if a nutrient-adequate diet closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans elicits a superior metabolic profile in persons at-risk for metabolic disease, compared to a nutrient-adequate containing foods closely aligned with the National Health and Nutrition Examination Survey (NHANES) "What We Eat In America" report. Further, the investigation will include effect modification of stress-related cortisol measures on change in cardiometabolic risk factors.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Western Human Nutrition Research Center
    • Sacramento, California, United States, 95817
      • Clinical Translational Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Premenopausal by self-report
• Body Mass Index 25-39.9 kg/m2
• Fasting glucose ≥100 and <126 mg/dL and/or
• Oral Glucose Tolerance Test (OGTT) 2-hour glucose ≥140 and <199 mg/dL and/or
• Quantitative insulin sensitivity check index (QUICKI) score <0.315 and/or
• Homeostasis Model Assessment (HOMA) >3.67, or log HOMA >0.085 and/or
• Glycated Hemoglobin HbA1c ≥5.7 and <6.5fasting glucose ≥100 and <126 mg/dL and/or
• Fasting triglyceride concentrations >150 mg/dL and/or
• LDL cholesterol >100 mg/dL and/or
• HDL cholesterol <40 mg/dL.

Exclusion Criteria:

• BMI <25 and >39.9 kg/m2
• Presence of any metabolic diseases, by self-report
• Gastrointestinal disorders by self-report
• Presence of cancer or other serious chronic disease by self-report
• Current use of prescribed or over the counter weight loss medications
• Pregnant
• Lactating
• Current use of tobacco
• Moderate or strenuous physical activity >30 min/day, 5 or more days per week
• Weight change >5% of body weight during the previous 6 months
• Dietary restrictions that would interfere with consuming the intervention foods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DGA Diet Plan; A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet will be closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans. All foods and beverages will be provided to enrolled subjects during the intervention period.	Other: DGA Diet Plan; A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet will be closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans.; Other Names: Dietary Guidelines for Americans Diet Plan
EXPERIMENTAL: NHANES Diet Plan; A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet plan will be closely aligned with the NHANES "What We Eat In America" report. All foods and beverages will be provided to enrolled subjects during the intervention period.	Other: NHANES Diet Plan; A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet will be closely aligned with the NHANES "What we eat in America" report.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Insulin Concentrations	Additional indicators of glucose-insulin sensitivity will be assessed including the Quantitative Insulin Sensitivity Check Index (QUICKI) score, Homeostasis Model Assessment (HOMA), and Matsuda Index	Weeks 1, 3, and 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lipid Profile	fasting triglyceride concentrations, LDL cholesterol, HDL cholesterol will be measured in serum as a composite measurement	Weeks 1, 3, and 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Metabolomic Profile	Endocannabinoids, Bile Acids, Amino Acids, Acyl Carnitines, Non-Esterified Fatty Acids, Oxylipins, Corticoids, Nitrate/Nitrite, and Tissue Lipid Profile will be measured in plasma, erythrocytes, and sebaceous secretions as a composite measurement.	Weeks 1,3, and 9
Change in Immunological Markers	Immunologic markers such as tumor necrosis factor-α, Interleukin-β, Interleukin-6, Interferon-γ, Interleukin-13, Interleukin-17A, Interleukin-10 will be measured in plasma and whole cell preparations as a composite measurement.	Weeks 1 and 9
Bio-Behavioral responses to diet intervention	Stress Reactivity, Allostatic Load, Autonomic Nervous System Output, and Cognitive Function will be recorded as a composite measurement.	Weeks 1 and 9
Change in responses to Behavioral questionnaires	Appetite, Food Preference, Diet Bias will be measured and reported as a composite measurement.	Weeks 1, 3, and 9
Change in Taste preference threshold	Sweet, salty, and bitter taste sensitivity will be evaluated using the three-alternative-forced choice method for determining recognition taste thresholds	Weeks 1 and 9
Change in intestinal microbiota	Assays will be performed on fecal samples to determine DNA representing the colonic microbiota, amount of organic acids and other metabolites of fermentation.	weeks 1, 3, 5 and 9
Change in usual physical activity	Usual physical activity will be measured by accelerometer worn for 7 days	weeks 1, 3, and 9
Change in body composition	Body composition (total body fat) will be measured by dual energy x-ray absorptiometry (DXA)	weeks 1 and 9
Change in vascular function	Vascular function assessment of peripheral arterial tone (PAT) measurement conducted at resting conditions and after a reactive hyperemia	weeks 1 and 9
Change in Framingham Risk Score	Calculated Framingham 10-year cardiovascular disease risk score	weeks 1, 3 and 9
Change in vascular age score	Calculated vascular age score	weeks 1, 3 and 9
Change in metabolic rate	Respiratory gas exchange measurements (oxygen consumption and carbon dioxide production) will be measured in response to a test meal	weeks 1, 3, and 9
Change in breath volatile gases	Alveolar air (breath) samples will be analyzed for hydrogen and methane, products produced by bacterial fermentation of carbohydrates in the gastrointestinal tract	weeks 1, 3, and 9
Usual diet	Usual diet will be measured once by food frequency questionnaire and 24 hour recall methodology	week 1
Change in post-translational glycosylation of select serum proteins (glycoproteome)	Serum circulating protein concentrations and their glycovariant distributions measured by Ultra High Pressure Liquid Chromatography - Mass Spectrometry (UHPLC-MS). Proteins selected based on their association to chronic metabolic disease, such as angiotensinogen, fibronectin, kininogen, kallikrein, apolipoprotein CIII, fetuin and vitronectin.	weeks 1, 3 and 9
Change in Trimethylamine Oxide (TMAO)	Fasting serum level of TMAO measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Change in choline	Fasting serum level of choline measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Change in carnitine	Fasting serum level of carnitine measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Change in betaine	Fasting serum level of betaine measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Change in creatinine	Fasting serum level of creatinine measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Fasting urinary cortisol	Cortisol was measured in 12-hour overnight urine samples collected prior to eating	weeks 1 and 9
Baseline and change in diurnal salivary cortisol	Cortisol was measured in saliva samples collected using a cotton swab (Salivette)	weeks 1 and 9; at nighttime before going to sleep and upon waking
Baseline and change in salivary cortisol response to a meal	Cortisol was measured in saliva samples collected using a cotton swab (Salivette)	weeks 1 and 9; at 60, 90, and 120 minutes after the initiation of a meal
Baseline and change in salivary cortisol response to stress	Cortisol was measured in saliva samples collected using a cotton swab (Salivette)	weeks 1 and 9; at 30, 60, 90, and 120 minutes after the start of a stress test

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Collaborators: University of California, Davis; University of Arkansas; Dairy Research Institute
• Investigators: Principal Investigator: Nancy L Keim, PhD, USDA, Western Human Nutrition Research Center

Publications and helpful links

General Publications

• Soltani H, Keim NL, Laugero KD. Waking Salivary Cortisol Associated with Magnitude of Cholesterol Reduction in Women Fed a Healthy Whole-Food Diet for 8 Weeks. Curr Dev Nutr. 2022 May 3;6(5):nzac083. doi: 10.1093/cdn/nzac083. eCollection 2022 May.
• Newman JW, Krishnan S, Borkowski K, Adams SH, Stephensen CB, Keim NL. Assessing Insulin Sensitivity and Postprandial Triglyceridemic Response Phenotypes With a Mixed Macronutrient Tolerance Test. Front Nutr. 2022 May 11;9:877696. doi: 10.3389/fnut.2022.877696. eCollection 2022.
• Richardson CE, Krishnan S, Gray IJ, Keim NL, Newman JW. The Omega-3 Index Response to an 8 Week Randomized Intervention Containing Three Fatty Fish Meals Per Week Is Influenced by Adiposity in Overweight to Obese Women. Front Nutr. 2022 Feb 4;9:810003. doi: 10.3389/fnut.2022.810003. eCollection 2022.
• Krishnan S, Gertz ER, Adams SH, Newman JW, Pedersen TL, Keim NL, Bennett BJ. Effects of a diet based on the Dietary Guidelines on vascular health and TMAO in women with cardiometabolic risk factors. Nutr Metab Cardiovasc Dis. 2022 Jan;32(1):210-219. doi: 10.1016/j.numecd.2021.09.013. Epub 2021 Sep 20.
• Artegoitia VM, Krishnan S, Bonnel EL, Stephensen CB, Keim NL, Newman JW. Healthy eating index patterns in adults by sex and age predict cardiometabolic risk factors in a cross-sectional study. BMC Nutr. 2021 Jun 22;7(1):30. doi: 10.1186/s40795-021-00432-4.
• Kim T, Xie Y, Li Q, Artegoitia VM, Lebrilla CB, Keim NL, Adams SH, Krishnan S. Diet affects glycosylation of serum proteins in women at risk for cardiometabolic disease. Eur J Nutr. 2021 Oct;60(7):3727-3741. doi: 10.1007/s00394-021-02539-7. Epub 2021 Mar 26.
• Krishnan S, Lee F, Burnett DJ, Kan A, Bonnel EL, Allen LH, Adams SH, Keim NL. Challenges in Designing and Delivering Diets and Assessing Adherence: A Randomized Controlled Trial Evaluating the 2010 Dietary Guidelines for Americans. Curr Dev Nutr. 2020 Feb 13;4(3):nzaa022. doi: 10.1093/cdn/nzaa022. eCollection 2020 Mar.
• Krishnan S, Adams SH, Allen LH, Laugero KD, Newman JW, Stephensen CB, Burnett DJ, Witbracht M, Welch LC, Que ES, Keim NL. A randomized controlled-feeding trial based on the Dietary Guidelines for Americans on cardiometabolic health indexes. Am J Clin Nutr. 2018 Aug 1;108(2):266-278. doi: 10.1093/ajcn/nqy113.

Helpful Links

• USDA Western Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2014
• Primary Completion (ACTUAL): March 30, 2017
• Study Completion (ACTUAL): March 30, 2017

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (ESTIMATE): November 24, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Insulin Resistance; US Dietary Guidelines
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: 648620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO