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CompletedNCT04382183

Impact of Ketogenic Diets in Preventing Relapse in Obesity Management

Evaluation of the Efficacy, Feasibility, and Safety of Ketogenic Diets in Preventing Relapse in Obesity Management

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Norwegian University of Science and Technology · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

Low-carb ketogenic diets have become extremely popular because of large weight loss in the short-term. Yet their potential benefits in preventing long-term weight regain have not been assessed in large scale studies. The aim of this study is to determine the effect of a low-carbohydrate (CHO) ketogenic diet, compared with an isocaloric balanced diet, on the maintenance of weight loss. The secondary aim is to investigate the impact of both diets on appetite. Adults with obesity (30\<BMI\<40 kg/m2), will first undergo 4 weeks of a very-low energy diet aimed at inducing 5-10% weight loss and then will be randomized to two different weight maintenance diets for 1 year. One will be a low-CHO ketogenic diet (50 g CHO/day) plant-based (e.g. with less animal protein and more plant-based), and the other a diet following the Norwegian Health Directorate recommendations. Only conventional foods will be used in both diets.

Conditions

Interventions

TypeNameDescription
BEHAVIORALKetogenic weight loss maintenance dietThe ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.
BEHAVIORALIsocaloric balanced weight loss maintenance dietThe isocaloric balanced weight loss maintenance group will undergo in a diet following the recommendations from the Norwegian Health Directorate for 1 year.

Timeline

Start date
2020-08-03
Primary completion
2021-12-10
Completion
2021-12-10
First posted
2020-05-11
Last updated
2022-04-29

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT04382183. Inclusion in this directory is not an endorsement.