Can a High-Protein or High-Fat Low-Carb diet tame blood sugar and triglycerides?
NCT ID NCT07801378
First seen Sep 03, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This trial tests whether two moderate low-carbohydrate diets, one higher in protein and one higher in fat, improve blood sugar, blood fats, and weight more than a standard diet. Adults with type 2 diabetes, high triglycerides, and overweight or obesity will follow one of the three calorie-restricted meal plans for 12 weeks. Researchers will measure changes in triglycerides, HbA1c, blood pressure, and body weight to see which approach offers the best metabolic benefits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two calorie-restricted moderate low-carbohydrate diets: one high-protein (30% protein, 30% fat) and one high-fat (15% protein, 45% fat), compared with a standard diet, delivered as individualized meals over 12 weeks.
- What this could lead to
- If one of these diets works better, it could point to a practical eating plan that helps people with type 2 diabetes, high triglycerides, and excess weight improve blood sugar and heart health without extra medication.
- What could go wrong
- This is a 12-week dietary study with 168 participants, so results may not apply to everyone or last long-term. People may find it hard to stick to the meal plans, and the diets might not produce meaningful differences in outcomes.
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.
- Participants
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About 168 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 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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30 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * Diagnosed with type 2 diabetes mellitus for at least 6 months * Fasting serum triglycerides between 200-399 mg/dL * Body mass index (BMI) between 25 and 35 kg/m\^2 * Age between 30 and 70 years * If taking medication for diabetes, dyslipidemia, or hypertension, dose stable for at least 8 weeks prior to enrollment * Able to follow the prescribed diet * Willing and able to provide informed consent Exclusion Criteria: * Fasting triglycerides of 400 mg/dL or higher, or lower than 200 mg/dL * HbA1c greater than 10.5% * eGFR less than 30 mL/min/1.73m\^2 * Type 1 diabetes or rare metabolic disorders * Severe renal, cardiac, or hepatic disease, or active pancreatitis * Established cardiovascular disease (myocardial infarction, stroke, coronary angioplasty or bypass surgery, or heart failure) * Pregnancy, breastfeeding, or planning pregnancy during the study * Psychiatric disorder or social circumstances that would prevent adherence to the dietary protocol * Change in dose or type of diabetes, lipid-lowering, or blood pressure medication within 8 weeks before enrollment or during the study * Use of weight-loss medications, protein supplements, or probiotics * Body weight change greater than 3% within the past 6 months * Withdrawal of consent to continue participation
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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