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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382183
Recruitment Status : Not yet recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Ketogenic weight loss maintenance diet Behavioral: Isocaloric balanced weight loss maintenance diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy, Feasibility, and Safety of Ketogenic Diets in Preventing Relapse in Obesity Management
Estimated Study Start Date : August 3, 2020
Estimated Primary Completion Date : February 3, 2021
Estimated Study Completion Date : August 3, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382183


Contacts
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Contact: Silvia Coutinho, PhD +4798639859 silvia.coutinho@ntnu.no
Contact: Cátia Martins, Professor +4772825358 catia.martins@ntnu.no

Locations
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Norway
Forsyningssenteret at NTNU
Trondheim, Norway
Contact: Silvia Couthinho, PhD       silvia.coutinho@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Study Director: Torstein Baade Rø, MD PhD NTNU Faculty of Medicine and Health Sciences, IKOM
Study Director: Birger Henning Endreseth, Professor St. Olvas Hospital
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT04382183    
Other Study ID Numbers: 2020/50405
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Diet, Ketogenic
Weight Loss
Body Weight
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms