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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ketogenic weight loss maintenance diet
Isocaloric balanced weight loss maintenance diet
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Diet, Ketogenic, Weight Loss, Body Weight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Forsyningssenteret at NTNU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ketogenic weight loss maintenance diet

Isocaloric balanced weight loss maintenance diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Body weight regain
Body weight will be measured at baseline, at week 5, at 6 months, and at 1 year

Secondary Outcome Measures

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
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

Full Information

First Posted
April 28, 2020
Last Updated
April 28, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04382183
Brief Title
Impact of Ketogenic Diets in Preventing Relapse in Obesity Management
Acronym
Ketomaintain
Official Title
Evaluation of the Efficacy, Feasibility, and Safety of Ketogenic Diets in Preventing Relapse in Obesity Management
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Diet, Ketogenic, Weight Loss, Body Weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic weight loss maintenance diet
Arm Type
Experimental
Arm Description
The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.
Arm Title
Isocaloric balanced weight loss maintenance diet
Arm Type
Experimental
Arm Description
The isocaloric balanced weight loss maintenance group will undergo in a diet following the standard Norwegian Health Directorate recommendations for 1 year.
Intervention Type
Behavioral
Intervention Name(s)
Ketogenic weight loss maintenance diet
Intervention Description
The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.
Intervention Type
Behavioral
Intervention Name(s)
Isocaloric balanced weight loss maintenance diet
Intervention Description
The isocaloric balanced weight loss maintenance group will undergo in a diet following the recommendations from the Norwegian Health Directorate for 1 year.
Primary Outcome Measure Information:
Title
Body weight regain
Description
Body weight will be measured at baseline, at week 5, at 6 months, and at 1 year
Time Frame
Body weight changes at 1-year intervention
Secondary Outcome Measure Information:
Title
Fasting lipid profile
Description
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
Time Frame
Lipid profile changes at 1-year intervention
Title
Bone mineral density
Description
Bone mineral density will be measured by Dual-energy X-ray absorptiometry (DXA) at baseline, at 6 months, and at 1 year
Time Frame
Bone mineral density changes at 1-year intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torstein Baade Rø, MD PhD
Organizational Affiliation
NTNU Faculty of Medicine and Health Sciences, IKOM
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Birger Henning Endreseth, Professor
Organizational Affiliation
St. Olvas Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Forsyningssenteret at NTNU
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Ketogenic Diets in Preventing Relapse in Obesity Management

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