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NCT03499509 · ClinicalTrials.gov registry record · NA

Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction

A NA study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
NA
Development phase
67
Enrollment target

NCT03499509: Completed NA study, sponsored by University of Alabama at Birmingham.

NCT03499509 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03499509, a NA study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
NA
Development phase
67 participants
Enrollment target

Study 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. 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.

Primary Outcome

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

Interventions

  • OTHER Low Glycemic Diet
  • OTHER High Glycemic Diet

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2019-03-19
Est. Completion 2024-04-30
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT03499509 record still lists

NCT03499509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Low Glycemic Diet is the first listed.

NCT03499509 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03499509 about?

NCT03499509 is a clinical study titled "Obesity Risk in African American Women is Determined by a Diet-by-phenotype Interaction". 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 in...

What is the current status of trial NCT03499509?

This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2019-03-19. Estimated completion is 2024-04-30.

What interventions are being tested in trial NCT03499509?

The interventions under investigation include: Low Glycemic Diet (OTHER), High Glycemic Diet (OTHER).

Who is sponsoring clinical trial NCT03499509?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03499509's enrollment target sits among peer trials

67 1139th of 2000 higher than 862 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03499509, the US trial registry maintained by the National Library of Medicine. NCT03499509 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.