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Individual Metabolism and Physiology Signature Study (iMAPS)

Primary Purpose

Insulin Resistance, Metabolic Syndrome X, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DGA Diet Plan
NHANES Diet Plan
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Insulin Resistance, Obesity, US Dietary Guidelines

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Western Human Nutrition Research Center
  • Clinical Translational Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DGA Diet Plan

NHANES Diet Plan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2014
Last Updated
September 27, 2021
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
Dairy Research Institute, University of California, Davis, University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT02298725
Brief Title
Individual Metabolism and Physiology Signature Study
Acronym
iMAPS
Official Title
Individual Metabolism and Physiology Signature Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 16, 2014 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
March 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
Dairy Research Institute, University of California, Davis, University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Metabolic Syndrome X, Obesity
Keywords
Insulin Resistance, Obesity, US Dietary Guidelines

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DGA Diet Plan
Arm Type
Experimental
Arm Description
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.
Arm Title
NHANES Diet Plan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
DGA Diet Plan
Other Intervention Name(s)
Dietary Guidelines for Americans Diet Plan
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NHANES Diet Plan
Intervention Description
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 Outcome Measure Information:
Title
Change in Fasting Insulin Concentrations
Description
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
Time Frame
Weeks 1, 3, and 9
Secondary Outcome Measure Information:
Title
Change in Lipid Profile
Description
fasting triglyceride concentrations, LDL cholesterol, HDL cholesterol will be measured in serum as a composite measurement
Time Frame
Weeks 1, 3, and 9
Other Pre-specified Outcome Measures:
Title
Change in Metabolomic Profile
Description
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.
Time Frame
Weeks 1,3, and 9
Title
Change in Immunological Markers
Description
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.
Time Frame
Weeks 1 and 9
Title
Bio-Behavioral responses to diet intervention
Description
Stress Reactivity, Allostatic Load, Autonomic Nervous System Output, and Cognitive Function will be recorded as a composite measurement.
Time Frame
Weeks 1 and 9
Title
Change in responses to Behavioral questionnaires
Description
Appetite, Food Preference, Diet Bias will be measured and reported as a composite measurement.
Time Frame
Weeks 1, 3, and 9
Title
Change in Taste preference threshold
Description
Sweet, salty, and bitter taste sensitivity will be evaluated using the three-alternative-forced choice method for determining recognition taste thresholds
Time Frame
Weeks 1 and 9
Title
Change in intestinal microbiota
Description
Assays will be performed on fecal samples to determine DNA representing the colonic microbiota, amount of organic acids and other metabolites of fermentation.
Time Frame
weeks 1, 3, 5 and 9
Title
Change in usual physical activity
Description
Usual physical activity will be measured by accelerometer worn for 7 days
Time Frame
weeks 1, 3, and 9
Title
Change in body composition
Description
Body composition (total body fat) will be measured by dual energy x-ray absorptiometry (DXA)
Time Frame
weeks 1 and 9
Title
Change in vascular function
Description
Vascular function assessment of peripheral arterial tone (PAT) measurement conducted at resting conditions and after a reactive hyperemia
Time Frame
weeks 1 and 9
Title
Change in Framingham Risk Score
Description
Calculated Framingham 10-year cardiovascular disease risk score
Time Frame
weeks 1, 3 and 9
Title
Change in vascular age score
Description
Calculated vascular age score
Time Frame
weeks 1, 3 and 9
Title
Change in metabolic rate
Description
Respiratory gas exchange measurements (oxygen consumption and carbon dioxide production) will be measured in response to a test meal
Time Frame
weeks 1, 3, and 9
Title
Change in breath volatile gases
Description
Alveolar air (breath) samples will be analyzed for hydrogen and methane, products produced by bacterial fermentation of carbohydrates in the gastrointestinal tract
Time Frame
weeks 1, 3, and 9
Title
Usual diet
Description
Usual diet will be measured once by food frequency questionnaire and 24 hour recall methodology
Time Frame
week 1
Title
Change in post-translational glycosylation of select serum proteins (glycoproteome)
Description
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.
Time Frame
weeks 1, 3 and 9
Title
Change in Trimethylamine Oxide (TMAO)
Description
Fasting serum level of TMAO measured by liquid chromatography mass spectrometry (LCMS)
Time Frame
weeks 1, 3 and 9
Title
Change in choline
Description
Fasting serum level of choline measured by liquid chromatography mass spectrometry (LCMS)
Time Frame
weeks 1, 3 and 9
Title
Change in carnitine
Description
Fasting serum level of carnitine measured by liquid chromatography mass spectrometry (LCMS)
Time Frame
weeks 1, 3 and 9
Title
Change in betaine
Description
Fasting serum level of betaine measured by liquid chromatography mass spectrometry (LCMS)
Time Frame
weeks 1, 3 and 9
Title
Change in creatinine
Description
Fasting serum level of creatinine measured by liquid chromatography mass spectrometry (LCMS)
Time Frame
weeks 1, 3 and 9
Title
Fasting urinary cortisol
Description
Cortisol was measured in 12-hour overnight urine samples collected prior to eating
Time Frame
weeks 1 and 9
Title
Baseline and change in diurnal salivary cortisol
Description
Cortisol was measured in saliva samples collected using a cotton swab (Salivette)
Time Frame
weeks 1 and 9; at nighttime before going to sleep and upon waking
Title
Baseline and change in salivary cortisol response to a meal
Description
Cortisol was measured in saliva samples collected using a cotton swab (Salivette)
Time Frame
weeks 1 and 9; at 60, 90, and 120 minutes after the initiation of a meal
Title
Baseline and change in salivary cortisol response to stress
Description
Cortisol was measured in saliva samples collected using a cotton swab (Salivette)
Time Frame
weeks 1 and 9; at 30, 60, 90, and 120 minutes after the start of a stress test

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy L Keim, PhD
Organizational Affiliation
USDA, Western Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
Clinical Translational Science Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35669046
Citation
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.
Results Reference
derived
PubMed Identifier
35634390
Citation
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.
Results Reference
derived
PubMed Identifier
35187036
Citation
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.
Results Reference
derived
PubMed Identifier
34895998
Citation
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.
Results Reference
derived
PubMed Identifier
34154665
Citation
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.
Results Reference
derived
PubMed Identifier
33770218
Citation
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.
Results Reference
derived
PubMed Identifier
32190808
Citation
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.
Results Reference
derived
PubMed Identifier
30101333
Citation
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.
Results Reference
derived
Links:
URL
http://www.ars.usda.gov/main/docs.htm?docid=11240
Description
USDA Western Human Nutrition Research Center

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Individual Metabolism and Physiology Signature Study

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