Impact of Ketogenic Diets in Preventing Relapse in Obesity Management

NCT04382183 | Completed

• 1 other identifier: 2020/50405
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Diet, Ketogenic; Weight Loss; Body Weight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fasting lipid profile

  Lipid profile changes at 1-year intervention

• Bone mineral density

  Bone mineral density changes at 1-year intervention

Study Arms (2)

Ketogenic weight loss maintenance diet

EXPERIMENTAL

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

Isocaloric balanced weight loss maintenance diet

EXPERIMENTAL

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

Interventions

Ketogenic weight loss maintenance diet BEHAVIORAL

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

Ketogenic weight loss maintenance diet

Isocaloric balanced weight loss maintenance diet BEHAVIORAL

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

Isocaloric balanced weight loss maintenance diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Forsyningssenteret at NTNU

Trondheim, Norway

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Torstein Baade Rø, MD PhD

  NTNU Faculty of Medicine and Health Sciences, IKOM

  STUDY DIRECTOR

• Birger Henning Endreseth, Professor

  St. Olvas Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 11, 2020
• Study Start: August 3, 2020
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)