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

The Impact of Betaine Supplementation on Body Composition and Lipid Metabolism in a Group of Overweight and Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Betaine

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland, 60-637
    • Poznan University of Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Betaine; 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.	Dietary supplement: Betaine; Betaine supplemented for 8 weeks
Placebo Comparator: Placebo; 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.	Dietary supplement: Placebo; Placebo supplementation for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass	Measured in kg	8 weeks, three measurements: at week 0, 4 and 8
Waist and hips circumference	Measured in cm	8 weeks, three measurements: at week 0, 4 and 8
Lipid profile	Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol	8 weeks, two measurements: at week 0 and 8
Gene expression	Included genes relate to lipid metabolism in adipose tissue: PPARG, CD36, FABP4, UCP1, PPARGC1A, LEP, ADIPOQ, INSR, IRS1, DGAT2, SREBF1, ELOVL5 , FADS3, FASN	8 weeks, two measurements: at week 0 and 8
Body composition	Body composition will include percent body fat and lean body mass measured with air displacement plethysmography	8 weeks, three measurements: at week 0, 4 and 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake	Based on food diary	8 weeks, two measurements: at week 0 and 8
Liver function test	activities of enzymes: ALT, AST, GGTP, ALP	8 weeks, two measurements: at week 0 and 8
sex hormones		8 weeks, two measurements: at week 0 and 8

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences
• Investigators: Principal Investigator: Agata Chumrzynska, Poznan University of Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Trimethyl Ammonium Compounds; Betaine
• Other Study ID Numbers: BETadiposeWOMEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No