Impact of Ketogenic Diets in Preventing Relapse in Obesity Management

NCT ID: NCT04382183

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2021-12-10

Brief 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

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ketogenic weight loss maintenance diet

The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.

Group Type: EXPERIMENTAL

Ketogenic weight loss maintenance diet

Intervention Type: BEHAVIORAL

The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.

Isocaloric balanced weight loss maintenance diet

The isocaloric balanced weight loss maintenance group will undergo in a diet following the standard Norwegian Health Directorate recommendations for 1 year.

Group Type: EXPERIMENTAL

Isocaloric balanced weight loss maintenance diet

Intervention Type: BEHAVIORAL

The isocaloric balanced weight loss maintenance group will undergo in a diet following the recommendations from the Norwegian Health Directorate for 1 year.

Interventions

Ketogenic weight loss maintenance diet

The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.

Intervention Type: BEHAVIORAL

Isocaloric balanced weight loss maintenance diet

The isocaloric balanced weight loss maintenance group will undergo in a diet following the recommendations from the Norwegian Health Directorate for 1 year.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• weight stable over the last three months (<2 kg)
• not currently dieting to lose weight
• inactive lifestyle (less than 150 min of physical activity weekly.
• Given that some of the variables of interest have been shown to be affected by the phase of menstrual cycle in normally ovulating women, namely appetite and resting metabolic rate, only women taking oral contraceptives, with regular menstrual cycles or post-menopausal will be included in the study

Exclusion Criteria

• pregnancy
• breast-feeding
• drug or alcohol abuse within the last two years
• clinically significant illness including diabetes, gastrointestinal (particularly cholelithiasis), kidney (GFR <60) or liver disease, osteoporosis (T-score <-2.5) and osteopenia (T-score <-1.5)
• treatment with antiosteoporotic drug
• depression or other psychological disorders
• eating disorders
• milk intolerance
• current medication known to affect appetite/metabolism or induce weight loss.
• a planned surgery during the study period
• participating in another research study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torstein Baade Rø, MD PhD

Role: STUDY_DIRECTOR

NTNU Faculty of Medicine and Health Sciences, IKOM

Birger Henning Endreseth, Professor

Role: STUDY_DIRECTOR

St. Olvas Hospital

Locations

Forsyningssenteret at NTNU

Trondheim, , Norway

Countries

Norway

Other Identifiers

2020/50405

Identifier Type: -

Identifier Source: org_study_id