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COMPLETED
NCT07830121
NA

Very-Low-Carbohydrate Diet for Prediabetes and Obesity

Sponsor: Universiti Teknologi Mara

View on ClinicalTrials.gov

Summary

Prediabetes is a condition where blood sugar is higher than normal but not yet high enough to be called type 2 diabetes. It is common in adults who are overweight or obese, and without treatment it often progresses to diabetes over time. This study looks at whether following a very-low-carbohydrate diet for 12 weeks can help adults with prediabetes and obesity lose weight, reduce body fat, and improve how well their body responds to insulin, compared with standard dietary advice. Adults aged 30 to 65 with obesity and newly diagnosed prediabetes are invited to take part. Participants are randomly assigned to one of two groups: one follows a very-low-carbohydrate diet with support from a dietitian, and the other receives standard dietary advice without a specific carbohydrate limit. Both groups are followed for 12 weeks, during which their weight, body composition, blood sugar, insulin levels, cholesterol, and kidney function are checked. The study aims to find out whether the very-low-carbohydrate diet leads to greater improvements in weight, body fat, and insulin sensitivity than standard advice, and whether it is safe and practical to follow in everyday life. The findings may help doctors and dietitians offer more effective ways to prevent prediabetes from progressing to type 2 diabetes.

Official title: Effects of a 12-Week Very-Low-Carbohydrate Diet on Body Composition and Cardiometabolic Outcomes in Adults With Prediabetes and Obesity: A Randomised Controlled Trial

Key Details

Gender

All

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2024-01-01

Completion Date

2025-12-01

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

BEHAVIORAL

Standard Dietary Advice

Participants received standard dietary advice with no specific carbohydrate restriction, with total caloric intake individualised to ideal body weight, the same dietitian counselling, and food diaries, for 12 weeks.

BEHAVIORAL

Very-Low-Carbohydrate Diet (VLCBD)

Participants received a very-low-carbohydrate diet (\<50 g carbohydrate/day), with total caloric intake individualised to ideal body weight, structured dietitian counselling, and food diaries, for 12 weeks.

Locations (1)

Hospital UITM

Sungai Buloh, Selangor, Malaysia