Clinical trial NCT04382183: Impact of Ketogenic Diets in Preventing Relapse in Obesity Management
Official title: Evaluation of the Efficacy, Feasibility, and Safety of Ketogenic Diets in Preventing Relapse in Obesity Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Diet, Ketogenic
Weight Loss
Body Weight
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2020-05-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Body weight regain
timeFrame: Body weight changes at 1-year intervention
Secondary outcomes:
measure: Fasting lipid profile
timeFrame: Lipid profile changes at 1-year intervention
measure: Bone mineral density
timeFrame: Bone mineral density changes at 1-year intervention
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Forsyningssenteret at NTNU
Study officials:
affiliation: NTNU Faculty of Medicine and Health Sciences, IKOM
name: Torstein Baade Rø, MD PhD
role: STUDY_DIRECTOR
affiliation: St. Olvas Hospital
name: Birger Henning Endreseth, Professor
role: STUDY_DIRECTOR
References: