NCT02298725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

December 16, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

November 18, 2014

Last Update Submit

March 20, 2026

Conditions

Insulin ResistanceMetabolic Syndrome XObesity

Keywords

Insulin ResistanceObesityUS Dietary Guidelines

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Lipid Profile

    Weeks 1, 3, and 9

Other Outcomes (24)

  • Change in Metabolomic Profile

    Weeks 1,3, and 9

  • Change in Immunological Markers

    Weeks 1 and 9

  • Bio-Behavioral responses to diet intervention

    Weeks 1 and 9

  • +21 more other outcomes

Study Arms (2)

DGA Diet Plan

EXPERIMENTAL

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

NHANES Diet Plan

EXPERIMENTAL

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

Interventions

DGA Diet PlanOTHER

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.

Also known as: Dietary Guidelines for Americans Diet Plan
DGA Diet Plan
NHANES Diet PlanOTHER

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.

NHANES Diet Plan

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Clinical Translational Science Center

Sacramento, California, 95817, United States

Location

Related Publications (11)

  • 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.

    PMID: 32190808BACKGROUND

  • Krishnan S, Freytag T, Jiang X, Schuster GU, Woodhouse LR, Keim NL, Stephensen CB. Effect of a diet based on the dietary guidelines for americans on inflammation markers in women at risk for cardiometabolic disease: results of a randomized, controlled trial. BMC Nutr. 2022 Dec 27;8(1):157. doi: 10.1186/s40795-022-00647-z.

    PMID: 36575541RESULT

  • 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.

    PMID: 35634390RESULT

  • 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.

    PMID: 35187036RESULT

  • 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.

    PMID: 34895998RESULT

  • Soltani H, Keim NL, Laugero KD. Increasing Dietary Carbohydrate as Part of a Healthy Whole Food Diet Intervention Dampens Eight Week Changes in Salivary Cortisol and Cortisol Responsiveness. Nutrients. 2019 Oct 24;11(11):2563. doi: 10.3390/nu11112563.

    PMID: 31652899RESULT

  • Soltani H, Keim NL, Laugero KD. Diet Quality for Sodium and Vegetables Mediate Effects of Whole Food Diets on 8-Week Changes in Stress Load. Nutrients. 2018 Nov 1;10(11):1606. doi: 10.3390/nu10111606.

    PMID: 30388762RESULT

  • 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.

    PMID: 30101333RESULT

  • 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.

    PMID: 35669046DERIVED

  • 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.

    PMID: 34154665DERIVED

  • 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.

    PMID: 33770218DERIVED

Related Links

MeSH Terms

Conditions

Insulin ResistanceMetabolic SyndromeObesity

Interventions

Nutrition Policy

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PolicyPublic PolicySocial Control PoliciesPolicyHealth Care Economics and Organizations

Study Officials

  • Nancy L Keim, PhD

    USDA, Western Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 24, 2014

Study Start

December 16, 2014

Primary Completion

March 30, 2017

Study Completion

March 30, 2017

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)