Individual Metabolism and Physiology Signature Study

Obesity Clinical Trial

— iMAPS  

Official title:

Individual Metabolism and Physiology Signature Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298725
• Other study ID #: 648620
• Status: Completed
• Phase: N/A
• Start date: December 16, 2014
• Est. completion date: March 30, 2017

Study information

• Verified date: September 2021
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Western Human Nutrition Research Center	Davis	California
United States	Clinical Translational Science Center	Sacramento	California

Sponsors (4)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	Dairy Research Institute, University of Arkansas, University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in Immunological Markers	Immunologic markers such as tumor necrosis factor-a, Interleukin-ß, Interleukin-6, Interferon-?, Interleukin-13, Interleukin-17A, Interleukin-10 will be measured in plasma and whole cell preparations as a composite measurement.	Weeks 1 and 9
Other	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
Other	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
Other	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
Other	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
Other	Change in usual physical activity	Usual physical activity will be measured by accelerometer worn for 7 days	weeks 1, 3, and 9
Other	Change in body composition	Body composition (total body fat) will be measured by dual energy x-ray absorptiometry (DXA)	weeks 1 and 9
Other	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
Other	Change in Framingham Risk Score	Calculated Framingham 10-year cardiovascular disease risk score	weeks 1, 3 and 9
Other	Change in vascular age score	Calculated vascular age score	weeks 1, 3 and 9
Other	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
Other	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
Other	Usual diet	Usual diet will be measured once by food frequency questionnaire and 24 hour recall methodology	week 1
Other	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
Other	Change in Trimethylamine Oxide (TMAO)	Fasting serum level of TMAO measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Other	Change in choline	Fasting serum level of choline measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Other	Change in carnitine	Fasting serum level of carnitine measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Other	Change in betaine	Fasting serum level of betaine measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Other	Change in creatinine	Fasting serum level of creatinine measured by liquid chromatography mass spectrometry (LCMS)	weeks 1, 3 and 9
Other	Fasting urinary cortisol	Cortisol was measured in 12-hour overnight urine samples collected prior to eating	weeks 1 and 9
Other	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
Other	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
Other	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
Primary	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	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

External Links

•   USDA Western Human Nutrition Research Center