Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women

Poznan University of Life Sciences

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Betaine; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06344377

BETadiposeWOMEN

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

Betaine

Experimental group

Description:

Betaine supplementation for 8 weeks, daily dose of 3 g/d, taken twice a day in a capsulated form. One capsule will contain 500 mg betaine. Daily number of capsules will be 2 x 3 = 6.

Treatment:

Dietary Supplement: Betaine

Placebo

Placebo Comparator group

Description:

Placebo will be inactive substance (maltodextrin) provided in the same-looking capsules as betaine. Placebo will be administered twice a day, daily number of capsules will be 2 x 3 = 6.

Treatment:

Dietary Supplement: Placebo