Impact of Ketogenic Diets in Preventing Relapse in Obesity Management (Ketomaintain)

Norwegian University of Science and Technology

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Isocaloric balanced weight loss maintenance diet; Behavioral: Ketogenic weight loss maintenance diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04382183

2020/50405

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Ketogenic weight loss maintenance diet

Experimental group

Description:

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

Treatment:

Behavioral: Ketogenic weight loss maintenance diet

Isocaloric balanced weight loss maintenance diet

Experimental group

Description:

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

Treatment:

Behavioral: Isocaloric balanced weight loss maintenance diet