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

NCT06344377 | Completed

• 1 other identifier: BETadiposeWOMEN
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Secondary Outcomes (3)

• Liver function test

  8 weeks, two measurements: at week 0 and 8

• Dietary intake

  8 weeks, two measurements: at week 0 and 8

• sex hormones

  8 weeks, two measurements: at week 0 and 8

Study Arms (2)

Betaine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Betaine DIETARY_SUPPLEMENT

Betaine supplemented for 8 weeks

Betaine

Placebo DIETARY_SUPPLEMENT

Placebo supplementation for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Sciences

Poznan, 60-637, Poland

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Betaine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Agata Chumrzynska

  Poznan University of Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: September 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)