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Completed

NCT Number: NCT04382183

Impact 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Forsyningssenteret at NTNU

Trondheim, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Body weight regain

    Time frame: Body weight changes at 1-year intervention

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

Secondary outcomes

  1. Fasting lipid profile

    Time frame: Lipid profile changes at 1-year intervention

    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

  2. Bone mineral density

    Time frame: Bone mineral density changes at 1-year intervention

    Bone mineral density will be measured by Dual-energy X-ray absorptiometry (DXA) at baseline, at 6 months, and at 1 year

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: Ketomaintain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 11, 2020
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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