Insulin ResistanceiMAPSNCT02298725
Individual Metabolism and Physiology Signature Study
A study testing DGA Diet Plan and NHANES Diet Plan in people with Insulin Resistance and Metabolic Syndrome X, run by USDA, Western Human Nutrition Research Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Metabolic Syndrome X, Obesity
- What is being tested?
- DGA Diet Plan and NHANES Diet Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2014to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Western Human Nutrition Research Center
Davis, California, 95616
Clinical Translational Science Center
Sacramento, California, 95817
About this study
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.
Read the 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.
- Conditions
- Insulin Resistance, Metabolic Syndrome X, Obesity
- Being tested
- DGA Diet Plan, NHANES Diet Plan
- Keywords
- Insulin Resistance, Obesity, US Dietary Guidelines
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DGA Diet PlanOther
Also called Dietary Guidelines for Americans 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: NHANES Diet Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Weeks 1, 3, and 9
Secondary outcomes (1)
Change in Lipid Profile
fasting triglyceride concentrations, LDL cholesterol, HDL cholesterol will be measured in serum as a composite measurement
Measured: Weeks 1, 3, and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start16 Dec 2014
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Dairy Research Institute, University of California, Davis, University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Nancy L Keim, PhD, Principal investigator, USDA, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298725
- Sponsor's protocol ID
- 648620
- Acronym
- iMAPS
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2014
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32190808Krishnan 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.
PubMed 36575541Newman 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.
PubMed 35634390Richardson 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.
PubMed 35187036Krishnan 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.
PubMed 34895998Soltani 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.
PubMed 31652899Soltani 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.
PubMed 30388762Krishnan 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.
PubMed 30101333Soltani 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.
PubMed 35669046Artegoitia 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.
PubMed 34154665Kim 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.
PubMed 33770218
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Metabolism and Physiology Signature Study
- ClinicalTrials.gov ID
- NCT02298725
- Acronym / sponsor ID
- iMAPS / 648620
- Conditions
- Insulin Resistance, Metabolic Syndrome X, Obesity
- Keywords
- Insulin Resistance, Obesity, US Dietary Guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- Dairy Research Institute, University of California, Davis, University of Arkansas
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DGA Diet Plan | Experimental | Other: DGA Diet PlanA 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. |
| NHANES Diet Plan | Experimental | Other: NHANES Diet PlanA 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DGA Diet PlanAlso: Dietary Guidelines for Americans Diet PlanA 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 | DGA Diet Plan |
| NHANES Diet PlanA 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. | Other | NHANES Diet Plan |
Primary outcome
Change in Fasting Insulin Concentrations
Time frame: 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
1 secondary outcome
Change in Lipid Profile
Time frame: Weeks 1, 3, and 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 32190808Krishnan 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 publication: PubMed 36575541Krishnan 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.
- Results publication: PubMed 35634390Newman 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 publication: PubMed 35187036Richardson 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 publication: PubMed 34895998Krishnan 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 publication: PubMed 31652899Soltani 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.
- Results publication: PubMed 30388762Soltani 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.
- Results publication: PubMed 30101333Krishnan 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.
- Derived from this study: PubMed 35669046Soltani 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.
- Derived from this study: PubMed 34154665Artegoitia 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.
- Derived from this study: PubMed 33770218Kim 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.
- USDA Western Human Nutrition Research CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy L Keim, PhD principal investigator
USDA, Western Human Nutrition Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DGA Diet Plan and NHANES Diet Plan in people with Insulin Resistance and Metabolic Syndrome X, run by USDA, Western Human Nutrition Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fasting Insulin Concentrations (time frame: Weeks 1, 3, and 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02298725, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.