Dietary energy restriction tested to reverse prediabetes – study withdrawn
NCT ID NCT06451055
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aimed to see if an 8-week low-calorie diet (about 1,300 calories per day) could reverse isolated impaired fasting glucose, a form of prediabetes, in overweight adults aged 35 to 65. Participants would have received pre-prepared meals and been monitored for changes in blood sugar and weight. However, the study was withdrawn before enrolling anyone, so no data are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-calorie diet (approximately 1,300 kcal/day)
- What this could lead to
- If it works, this could point toward a simple dietary approach to reverse early prediabetes without medication.
- What could go wrong
- The study was withdrawn before any participants enrolled, so no results are available. Dietary interventions can be hard to stick with long-term, and effects may not last.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 35 to 65 years 2. Overweight (body mass index (BMI) ≥25 to \<29 kg/m² or ≥23 to \<29 kg/m² if Asian descent) or Obese (BMI ≥30 kg/m²) 3. Physically inactive (\<150 minutes per week of moderate-intensity physical activity or \<75 minutes per week of vigorous-intensity physical activity) 4. Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool Exclusion Criteria: 1. Diagnosed with type 1 or type 2 diabetes 2. Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions) 3. Chronic kidney disease 4. Chronic liver disease (e.g., cirrhosis) 5. Cancers 6. Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption 7. Food allergies 8. Participation in weight loss programs in the past six months 9. Currently following a specific diet (e.g., ketogenic diet, Mediterranean diet) 10. Participation in any exercise programs in the past six months 11. Currently taking weight-loss medications or drugs known to affect glycemia (steroids and antipsychotics) 12. Previous bariatric surgery or plan to have bariatric surgery during the study period 13. Planning to relocate during the study period 14. Intending to fast during the study period for religious or other reasons 15. Pregnancy or planning to become pregnant during the study period 16. Breastfeeding 17. Non-English speaker
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs)
Atlanta, Georgia, 30322, United States
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