Clinical trial NCT02298725: Individual Metabolism and Physiology Signature Study
Official title: Individual Metabolism and Physiology Signature Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Metabolic Syndrome X
Obesity
Keywords: Insulin Resistance
Obesity
US Dietary Guidelines
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Dairy Research Institute
name: University of California, Davis
name: University of Arkansas
First posted: 2014-11-24
Enrollment: 52
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in Fasting Insulin Concentrations
timeFrame: Weeks 1, 3, and 9
Secondary outcomes:
measure: Change in Lipid Profile
timeFrame: Weeks 1, 3, and 9
Other outcomes:
measure: Change in Metabolomic Profile
timeFrame: Weeks 1,3, and 9
measure: Change in Immunological Markers
timeFrame: Weeks 1 and 9
measure: Bio-Behavioral responses to diet intervention
timeFrame: Weeks 1 and 9
measure: Change in responses to Behavioral questionnaires
timeFrame: Weeks 1, 3, and 9
measure: Change in Taste preference threshold
timeFrame: Weeks 1 and 9
measure: Change in intestinal microbiota
timeFrame: weeks 1, 3, 5 and 9
measure: Change in usual physical activity
timeFrame: weeks 1, 3, and 9
measure: Change in body composition
timeFrame: weeks 1 and 9
measure: Change in vascular function
timeFrame: weeks 1 and 9
measure: Change in Framingham Risk Score
timeFrame: weeks 1, 3 and 9
measure: Change in vascular age score
timeFrame: weeks 1, 3 and 9
measure: Change in metabolic rate
timeFrame: weeks 1, 3, and 9
measure: Change in breath volatile gases
timeFrame: weeks 1, 3, and 9
measure: Usual diet
timeFrame: week 1
measure: Change in post-translational glycosylation of select serum proteins (glycoproteome)
timeFrame: weeks 1, 3 and 9
measure: Change in Trimethylamine Oxide (TMAO)
timeFrame: weeks 1, 3 and 9
measure: Change in choline
timeFrame: weeks 1, 3 and 9
measure: Change in carnitine
timeFrame: weeks 1, 3 and 9
measure: Change in betaine
timeFrame: weeks 1, 3 and 9
measure: Change in creatinine
timeFrame: weeks 1, 3 and 9
measure: Fasting urinary cortisol
timeFrame: weeks 1 and 9
measure: Baseline and change in diurnal salivary cortisol
timeFrame: weeks 1 and 9; at nighttime before going to sleep and upon waking
measure: Baseline and change in salivary cortisol response to a meal
timeFrame: weeks 1 and 9; at 60, 90, and 120 minutes after the initiation of a meal
measure: Baseline and change in salivary cortisol response to stress
timeFrame: weeks 1 and 9; at 30, 60, 90, and 120 minutes after the start of a stress test
Locations:
city: Davis
country: United States
facility: Western Human Nutrition Research Center
state: California
city: Sacramento
country: United States
facility: Clinical Translational Science Center
state: California
Study officials:
affiliation: USDA, Western Human Nutrition Research Center
name: Nancy L Keim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.