Impact of Ketogenic Diets in Preventing Relapse in Obesity Management

Obesity Clinical Trial

— Ketomaintain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382183
• Other study ID #: 2020/50405
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: December 10, 2021

Study information

• Verified date: April 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Norway	Forsyningssenteret at NTNU	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight regain	Body weight will be measured at baseline, at week 5, at 6 months, and at 1 year	Body weight changes at 1-year intervention
Secondary	Fasting lipid profile	Blood sampling in fasting to measure lipid profile (plasma concentration of total cholesterol, triglycerides, high-density lipids (HDL), low-density lipids (LDL) at baseline, at 6 months, and at 1 year	Lipid profile changes at 1-year intervention
Secondary	Bone mineral density	Bone mineral density will be measured by Dual-energy X-ray absorptiometry (DXA) at baseline, at 6 months, and at 1 year	Bone mineral density changes at 1-year intervention