iMAPS: Individual Metabolism and Physiology Signature Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Fasting Insulin Concentrations [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 Outcome Measures
- Change in Lipid Profile [Weeks 1, 3, and 9]
fasting triglyceride concentrations, LDL cholesterol, HDL cholesterol will be measured in serum as a composite measurement
Other Outcome Measures
- Change in Metabolomic Profile [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.
- Change in Immunological Markers [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.
- Bio-Behavioral responses to diet intervention [Weeks 1 and 9]
Stress Reactivity, Allostatic Load, Autonomic Nervous System Output, and Cognitive Function will be recorded as a composite measurement.
- Change in responses to Behavioral questionnaires [Weeks 1, 3, and 9]
Appetite, Food Preference, Diet Bias will be measured and reported as a composite measurement.
- Change in Taste preference threshold [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
- Change in intestinal microbiota [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.
- Change in usual physical activity [weeks 1, 3, and 9]
Usual physical activity will be measured by accelerometer worn for 7 days
- Change in body composition [weeks 1 and 9]
Body composition (total body fat) will be measured by dual energy x-ray absorptiometry (DXA)
- Change in vascular function [weeks 1 and 9]
Vascular function assessment of peripheral arterial tone (PAT) measurement conducted at resting conditions and after a reactive hyperemia
- Change in Framingham Risk Score [weeks 1, 3 and 9]
Calculated Framingham 10-year cardiovascular disease risk score
- Change in vascular age score [weeks 1, 3 and 9]
Calculated vascular age score
- Change in metabolic rate [weeks 1, 3, and 9]
Respiratory gas exchange measurements (oxygen consumption and carbon dioxide production) will be measured in response to a test meal
- Change in breath volatile gases [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
- Usual diet [week 1]
Usual diet will be measured once by food frequency questionnaire and 24 hour recall methodology
- Change in post-translational glycosylation of select serum proteins (glycoproteome) [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.
- Change in Trimethylamine Oxide (TMAO) [weeks 1, 3 and 9]
Fasting serum level of TMAO measured by liquid chromatography mass spectrometry (LCMS)
- Change in choline [weeks 1, 3 and 9]
Fasting serum level of choline measured by liquid chromatography mass spectrometry (LCMS)
- Change in carnitine [weeks 1, 3 and 9]
Fasting serum level of carnitine measured by liquid chromatography mass spectrometry (LCMS)
- Change in betaine [weeks 1, 3 and 9]
Fasting serum level of betaine measured by liquid chromatography mass spectrometry (LCMS)
- Change in creatinine [weeks 1, 3 and 9]
Fasting serum level of creatinine measured by liquid chromatography mass spectrometry (LCMS)
- Fasting urinary cortisol [weeks 1 and 9]
Cortisol was measured in 12-hour overnight urine samples collected prior to eating
- Baseline and change in diurnal salivary cortisol [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)
- Baseline and change in salivary cortisol response to a meal [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)
- Baseline and change in salivary cortisol response to stress [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Premenopausal by self-report
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Body Mass Index 25-39.9 kg/m2
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Fasting glucose ≥100 and <126 mg/dL and/or
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Oral Glucose Tolerance Test (OGTT) 2-hour glucose ≥140 and <199 mg/dL and/or
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Quantitative insulin sensitivity check index (QUICKI) score <0.315 and/or
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Homeostasis Model Assessment (HOMA) >3.67, or log HOMA >0.085 and/or
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Glycated Hemoglobin HbA1c ≥5.7 and <6.5fasting glucose ≥100 and <126 mg/dL and/or
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Fasting triglyceride concentrations >150 mg/dL and/or
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LDL cholesterol >100 mg/dL and/or
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HDL cholesterol <40 mg/dL.
Exclusion Criteria:
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BMI <25 and >39.9 kg/m2
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Presence of any metabolic diseases, by self-report
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Gastrointestinal disorders by self-report
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Presence of cancer or other serious chronic disease by self-report
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Current use of prescribed or over the counter weight loss medications
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Pregnant
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Lactating
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Current use of tobacco
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Moderate or strenuous physical activity >30 min/day, 5 or more days per week
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Weight change >5% of body weight during the previous 6 months
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Dietary restrictions that would interfere with consuming the intervention foods
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Western Human Nutrition Research Center | Davis | California | United States | 95616 |
| 2 | Clinical Translational Science Center | Sacramento | California | United States | 95817 |
Sponsors and Collaborators
- USDA, Western Human Nutrition Research Center
- Dairy Research Institute
- University of California, Davis
- University of Arkansas
Investigators
- Principal Investigator: Nancy L Keim, PhD, USDA, Western Human Nutrition Research Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 648620