Diet ModificationCHAMPIONNCT03499509
Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction
A study testing Low Glycemic Diet and High Glycemic Diet in people with Diet Modification, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The Scientific Premise of this study is that the high level of obesity displayed by African American (AA) women is due to the ability to secrete large amounts of insulin when sugary foods are consumed. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Low Glycemic Diet and High Glycemic Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 30-45 kg/m2
- Sedentary to moderately active (<2 hours/wk of moderate, structured, intentional exercise.
- Normal menstrual cycle
Who cannot join
- History of eating disorder
- daily use of tobacco (>1 pack/wk)
- change in weight greater than 5 pounds in previous 3 months
- presence of any condition (e.g. PCOS) or use of any medication (e.g. glucocorticoid) deemed by the project physician to interfere with study outcomes
- applicants will be screened with a standard oral glucose tolerance test. If a participant's 2 hour glucose if >200, they will not be able to enroll in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The Scientific Premise of this study is that the high level of obesity displayed by African American (AA) women is due to the ability to secrete large amounts of insulin when sugary foods are consumed. When AA women eat a diet rich in starchy or sugary food (a "high-glycemic" diet that stimulates insulin secretion), the food that is eaten is stored as fat rather than being burned as fuel. The investigators previous research has suggested that AA women have an easier time losing weight and keeping it off when eating a low-glycemic diet. The proposed study will be the first randomized clinical trial to test the effect of high and low glycemic diets for weight loss and weight-loss-maintenance in obese AA women.
- Conditions
- Diet Modification
- Being tested
- Low Glycemic Diet, High Glycemic Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic DietOther
Also called Low Carbohydrate Diet
Low Glycemic (LG) diet: The LG diet was made up of foods that do not stimulate insulin secretion and was composed of 20% CHO, 55% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet.
High Glycemic DietOther
Also called Low Fat Diet
High Glycemic (HG) diet: The HG diet aligned with the United States Department of Agriculture (USDA) guidelines (http://health.gov/dietaryguidelines/2015/guidelines/) and was composed of 55% CHO, 20% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet.
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Diet | Experimental | Low Glycemic (LG) diet: The LG diet was made up of foods that do not stimulate insulin secretion and was composed of 20% CHO, 55% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet. Receives: Other: Low Glycemic Diet |
| High Glycemic Diet | Placebo comparator | High Glycemic (HG) diet: The HG diet aligned with the United States Department of Agriculture (USDA) guidelines (http://health.gov/dietaryguidelines/2015/guidelines/) and was composed of 55% CHO, 20% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet. Receives: Other: High Glycemic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Energy Expenditure
Total energy expenditure measured by doubly labeled water. The protocol is based on established procedures [12]. Urine samples are analyzed in duplicate for H218O and 2H2O enrichments using Thermo Scientific Delta V Advantage IRMS with GasBench. CO2 production rates are determined using a fixed assumption for the dilution space ratio (1.043), using Equation 3 of Speakman et al. [10], and energy expenditure is calculated with equation 5 of Speakman et al. [10].
[10] Speakman JR, Yamada Y, Sagayama H et al. A standard calculation methodology for human doubly labeled water studies. Cell Rep Med 2021; 2:100203.
[12] Goran MI, Carpenter WH, McGloin A et al. Energy expenditure in children of lean and obese parents. American Journal of Physiology 1995; 31:E917-E924.
[13] Wolfe RR. Measurement of Total Energy Expenditure Using the Doubly-Labeled Water Method. In: Radioactive and Stable Isotope Tracers in Biomedicine. Edited by: Wiley-Liss. 1992.
Measured: Baseline, Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start19 Mar 2019
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Gower, University of Alabama at Birmingham
- Investigators
- Barbara Gower, PhD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499509
- Sponsor's protocol ID
- IRB-300001324
- Other IDs
- R01DK115483-01A1
- Acronym
- CHAMPION
- Status last verified
- May 2025
- First submitted
- 4 Apr 2018
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez Torres SY, Gower BA, Garvey WT, Martins C. Adaptive Thermogenesis After Hypocaloric Low-Carbohydrate Versus Low-Fat Diets in African American Women: A Secondary Analysis. Obesity (Silver Spring). 2025 Nov;33(11):2160-2169. doi: 10.1002/oby.70020. Epub 2025 Sep 10.
PubMed 40931394
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction
- ClinicalTrials.gov ID
- NCT03499509
- Acronym / sponsor ID
- CHAMPION / IRB-300001324
- Conditions
- Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Scientific Premise of this study is that the high level of obesity displayed by African American (AA) women is due to the ability to secrete large amounts of insulin when sugary foods are consumed. When AA women eat a diet rich in starchy or sugary food (a "high-glycemic" diet that stimulates insulin secretion), the food that is eaten is stored as fat rather than being burned as fuel. The investigators previous research has suggested that AA women have an easier time losing weight and keeping it off when eating a low-glycemic diet. The proposed study will be the first randomized clinical trial to test the effect of high and low glycemic diets for weight loss and weight-loss-maintenance in obese AA women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Diet | Experimental | Other: Low Glycemic DietLow Glycemic (LG) diet: The LG diet was made up of foods that do not stimulate insulin secretion and was composed of 20% CHO, 55% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet. |
| High Glycemic Diet | Placebo comparator | Other: High Glycemic DietHigh Glycemic (HG) diet: The HG diet aligned with the United States Department of Agriculture (USDA) guidelines (http://health.gov/dietaryguidelines/2015/guidelines/) and was composed of 55% CHO, 20% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 30-45 kg/m2
- Sedentary to moderately active (<2 hours/wk of moderate, structured, intentional exercise.
- Normal menstrual cycle
Key exclusion criteria (5 listed)
- History of eating disorder
- daily use of tobacco (>1 pack/wk)
- change in weight greater than 5 pounds in previous 3 months
- presence of any condition (e.g. PCOS) or use of any medication (e.g. glucocorticoid) deemed by the project physician to interfere with study outcomes
- applicants will be screened with a standard oral glucose tolerance test. If a participant's 2 hour glucose if >200, they will not be able to enroll in the study.
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 |
|---|---|---|
| Low Glycemic DietAlso: Low Carbohydrate DietLow Glycemic (LG) diet: The LG diet was made up of foods that do not stimulate insulin secretion and was composed of 20% CHO, 55% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet. | Other | Low Glycemic Diet |
| High Glycemic DietAlso: Low Fat DietHigh Glycemic (HG) diet: The HG diet aligned with the United States Department of Agriculture (USDA) guidelines (http://health.gov/dietaryguidelines/2015/guidelines/) and was composed of 55% CHO, 20% fat, and 25% protein. The diet emphasized complex over simple carbohydrates and allowed dairy products, fruits, and vegetables within allowance of the diet. | Other | High Glycemic Diet |
Primary outcome
Total Energy Expenditure
Time frame: Baseline, Week 13
Total energy expenditure measured by doubly labeled water. The protocol is based on established procedures [12]. Urine samples are analyzed in duplicate for H218O and 2H2O enrichments using Thermo Scientific Delta V Advantage IRMS with GasBench. CO2 production rates are determined using a fixed assumption for the dilution space ratio (1.043), using Equation 3 of Speakman et al. [10], and energy expenditure is calculated with equation 5 of Speakman et al. [10]. [10] Speakman JR, Yamada Y, Sagayama H et al. A standard calculation methodology for human doubly labeled water studies. Cell Rep Med 2021; 2:100203. [12] Goran MI, Carpenter WH, McGloin A et al. Energy expenditure in children of lean and obese parents. American Journal of Physiology 1995; 31:E917-E924. [13] Wolfe RR. Measurement of Total Energy Expenditure Using the Doubly-Labeled Water Method. In: Radioactive and Stable Isotope Tracers in Biomedicine. Edited by: Wiley-Liss. 1992.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40931394Lopez Torres SY, Gower BA, Garvey WT, Martins C. Adaptive Thermogenesis After Hypocaloric Low-Carbohydrate Versus Low-Fat Diets in African American Women: A Secondary Analysis. Obesity (Silver Spring). 2025 Nov;33(11):2160-2169. doi: 10.1002/oby.70020. Epub 2025 Sep 10.
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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.
Barbara Gower, PhD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Diet and High Glycemic Diet in people with Diet Modification, run by University of Alabama at Birmingham at 1 site 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 3 inclusion and 5 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 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Energy Expenditure (time frame: Baseline, Week 13). 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 NCT03499509, which also lists 1 linked publication.
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 18 May 2025.