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Completed

NCT Number: NCT06344377

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Life Sciences

Poznan, 60-637, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betaine

Dietary Supplement

Betaine supplemented for 8 weeks

Placebo

Dietary Supplement

Placebo supplementation for 8 weeks

Primary outcomes

  1. Body composition

    Time frame: 8 weeks, three measurements: at week 0, 4 and 8

    Body composition will include percent body fat and lean body mass measured with air displacement plethysmography

  2. Body mass

    Time frame: 8 weeks, three measurements: at week 0, 4 and 8

    Measured in kg

  3. Waist and hips circumference

    Time frame: 8 weeks, three measurements: at week 0, 4 and 8

    Measured in cm

  4. Lipid profile

    Time frame: 8 weeks, two measurements: at week 0 and 8

    Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol

  5. Gene expression

    Time frame: 8 weeks, two measurements: at week 0 and 8

    Included genes relate to lipid metabolism in adipose tissue: PPARG, CD36, FABP4, UCP1, PPARGC1A, LEP, ADIPOQ, INSR, IRS1, DGAT2, SREBF1, ELOVL5 , FADS3, FASN

Secondary outcomes

  1. Liver function test

    Time frame: 8 weeks, two measurements: at week 0 and 8

    activities of enzymes: ALT, AST, GGTP, ALP

  2. Dietary intake

    Time frame: 8 weeks, two measurements: at week 0 and 8

    Based on food diary

  3. sex hormones

    Time frame: 8 weeks, two measurements: at week 0 and 8

Sponsors and collaborators

Lead sponsor

Poznan University of Life Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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