Clinical trial NCT06344377: Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women
Official title: The Impact of Betaine Supplementation on Body Composition and Lipid Metabolism in a Group of Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity represents a serious global health issue with significant consequences, including an increased risk of chronic diseases. Statistics indicate a growing trend of obesity, highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications. Previous research on animals has shown that betaine, a substance engaged in one-carbon metabolism, may enhance fat oxidation and lower adipose tissue. Therefore, the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers, as well as expression of genes related to lipid metabolism, in a group of adult women with abdominal obesity.

This study is designed in a placebo-controlled, double-blinded, randomized fashion. The participants will be overweight or obese pre-menopausal females. Upon enrollment, participants will be randomly assigned to one of two parallel groups: betaine (3g/d) or placebo. The supplementation period will last for 8 weeks. There will be three study meetings: T1 before supplementation, T2 after 4 weeks of supplementation, and T3 after 8 weeks of supplementation. Blood will be drawn and body composition measured, and adipose tissue biopsy taken at meetings T1 and T3. The T2 meeting will involve only body composition measurement. Study outcomes will include body mass and composition (including body fat percent), lipid profile, and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells.


Eligibility criteria: Inclusion Criteria:

* females
* age: 18-45 years
* pre-menopausal
* overweight or obese: BMI \>25 kg/m2
* waist circumference \> 80 cm

Exclusion Criteria:

* males
* age \<18 or \>45 years
* perimenopausal or postmenopausal
* BMI \< 25 kg/m2
* waist circumference \< 80 cm
* betaine administration for 3 months prior to study
* pregnant or breastfeeding

Primary outcomes:
measure: Body composition
timeFrame: 8 weeks, three measurements: at week 0, 4 and 8
measure: Body mass
timeFrame: 8 weeks, three measurements: at week 0, 4 and 8
measure: Waist and hips circumference
timeFrame: 8 weeks, three measurements: at week 0, 4 and 8
measure: Lipid profile
timeFrame: 8 weeks, two measurements: at week 0 and 8
measure: Gene expression
timeFrame: 8 weeks, two measurements: at week 0 and 8
Secondary outcomes:
measure: Liver function test
timeFrame: 8 weeks, two measurements: at week 0 and 8
measure: Dietary intake
timeFrame: 8 weeks, two measurements: at week 0 and 8
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
Study officials:
affiliation: Poznan University of Life Sciences
name: Agata Chumrzynska
role: PRINCIPAL_INVESTIGATOR
References: