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Completed

NCT Number: NCT02298725

Individual Metabolism and Physiology Signature Study

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Western Human Nutrition Research Center, Davis, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DGA Diet Plan

Other

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

NHANES Diet Plan

Other

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.

Primary outcomes

  1. Change in Fasting Insulin Concentrations

    Time frame: Weeks 1, 3, and 9

    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

Secondary outcomes

  1. Change in Lipid Profile

    Time frame: Weeks 1, 3, and 9

    fasting triglyceride concentrations, LDL cholesterol, HDL cholesterol will be measured in serum as a composite measurement

Other outcomes

  1. Change in Metabolomic Profile

    Time frame: Weeks 1,3, and 9

    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.

  2. Change in Immunological Markers

    Time frame: Weeks 1 and 9

    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.

  3. Bio-Behavioral responses to diet intervention

    Time frame: Weeks 1 and 9

    Stress Reactivity, Allostatic Load, Autonomic Nervous System Output, and Cognitive Function will be recorded as a composite measurement.

  4. Change in responses to Behavioral questionnaires

    Time frame: Weeks 1, 3, and 9

    Appetite, Food Preference, Diet Bias will be measured and reported as a composite measurement.

  5. Change in Taste preference threshold

    Time frame: Weeks 1 and 9

    Sweet, salty, and bitter taste sensitivity will be evaluated using the three-alternative-forced choice method for determining recognition taste thresholds

  6. Change in intestinal microbiota

    Time frame: weeks 1, 3, 5 and 9

    Assays will be performed on fecal samples to determine DNA representing the colonic microbiota, amount of organic acids and other metabolites of fermentation.

  7. Change in usual physical activity

    Time frame: weeks 1, 3, and 9

    Usual physical activity will be measured by accelerometer worn for 7 days

  8. Change in body composition

    Time frame: weeks 1 and 9

    Body composition (total body fat) will be measured by dual energy x-ray absorptiometry (DXA)

  9. Change in vascular function

    Time frame: weeks 1 and 9

    Vascular function assessment of peripheral arterial tone (PAT) measurement conducted at resting conditions and after a reactive hyperemia

  10. Change in Framingham Risk Score

    Time frame: weeks 1, 3 and 9

    Calculated Framingham 10-year cardiovascular disease risk score

  11. Change in vascular age score

    Time frame: weeks 1, 3 and 9

    Calculated vascular age score

  12. Change in metabolic rate

    Time frame: weeks 1, 3, and 9

    Respiratory gas exchange measurements (oxygen consumption and carbon dioxide production) will be measured in response to a test meal

  13. Change in breath volatile gases

    Time frame: weeks 1, 3, and 9

    Alveolar air (breath) samples will be analyzed for hydrogen and methane, products produced by bacterial fermentation of carbohydrates in the gastrointestinal tract

  14. Usual diet

    Time frame: week 1

    Usual diet will be measured once by food frequency questionnaire and 24 hour recall methodology

  15. Change in post-translational glycosylation of select serum proteins (glycoproteome)

    Time frame: weeks 1, 3 and 9

    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.

  16. Change in Trimethylamine Oxide (TMAO)

    Time frame: weeks 1, 3 and 9

    Fasting serum level of TMAO measured by liquid chromatography mass spectrometry (LCMS)

  17. Change in choline

    Time frame: weeks 1, 3 and 9

    Fasting serum level of choline measured by liquid chromatography mass spectrometry (LCMS)

  18. Change in carnitine

    Time frame: weeks 1, 3 and 9

    Fasting serum level of carnitine measured by liquid chromatography mass spectrometry (LCMS)

  19. Change in betaine

    Time frame: weeks 1, 3 and 9

    Fasting serum level of betaine measured by liquid chromatography mass spectrometry (LCMS)

  20. Change in creatinine

    Time frame: weeks 1, 3 and 9

    Fasting serum level of creatinine measured by liquid chromatography mass spectrometry (LCMS)

  21. Fasting urinary cortisol

    Time frame: weeks 1 and 9

    Cortisol was measured in 12-hour overnight urine samples collected prior to eating

  22. Baseline and change in diurnal salivary cortisol

    Time frame: weeks 1 and 9; at nighttime before going to sleep and upon waking

    Cortisol was measured in saliva samples collected using a cotton swab (Salivette)

  23. Baseline and change in salivary cortisol response to a meal

    Time frame: weeks 1 and 9; at 60, 90, and 120 minutes after the initiation of a meal

    Cortisol was measured in saliva samples collected using a cotton swab (Salivette)

  24. Baseline and change in salivary cortisol response to stress

    Time frame: weeks 1 and 9; at 30, 60, 90, and 120 minutes after the start of a stress test

    Cortisol was measured in saliva samples collected using a cotton swab (Salivette)

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • Dairy Research Institute
  • University of Arkansas
  • University of California, Davis

Registry information

Acronym: iMAPS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 24, 2014
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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