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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Ketogenic weight loss maintenance diet; Behavioral: Isocaloric balanced weight loss maintenance diet

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Forsyningssenteret at NTNU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Director: Torstein Baade Rø, MD PhD, NTNU Faculty of Medicine and Health Sciences, IKOM; Study Director: Birger Henning Endreseth, Professor, St. Olvas Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Weight Loss; Body Weight; Diet, Ketogenic
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2020/50405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No