Overweight and ObesityNCT06344377
Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women
A study testing Betaine in people with Overweight and Obesity, run by Poznan University of Life Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Betaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- females
- age: 18-45 years
- pre-menopausal
- overweight or obese: BMI >25 kg/m2
- waist circumference > 80 cm
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight and Obesity
- Being tested
- Betaine, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaineDietary supplement
Betaine supplemented for 8 weeks
PlaceboDietary supplement
Placebo supplementation for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Body composition will include percent body fat and lean body mass measured with air displacement plethysmography
Measured: 8 weeks, three measurements: at week 0, 4 and 8
Body mass
Measured in kg
Measured: 8 weeks, three measurements: at week 0, 4 and 8
Waist and hips circumference
Measured in cm
Measured: 8 weeks, three measurements: at week 0, 4 and 8
Lipid profile
Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol
Measured: 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
Measured: 8 weeks, two measurements: at week 0 and 8
Secondary outcomes (3)
Liver function test
activities of enzymes: ALT, AST, GGTP, ALP
Measured: 8 weeks, two measurements: at week 0 and 8
Dietary intake
Based on food diary
Measured: 8 weeks, two measurements: at week 0 and 8
sex hormones
Measured: 8 weeks, two measurements: at week 0 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Sep 2024
- Primary completion30 Jun 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agata Chmurzyńska, Poznan University of Life Sciences
- Investigators
- Agata Chumrzynska, Principal investigator, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344377
- Sponsor's protocol ID
- BETadiposeWOMEN
- Status last verified
- Sep 2025
- First submitted
- 27 Mar 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zawieja E, Mlodzik-Czyzewska M, Chmurzynska A. Betaine supplementation modulates mitochondrial and redox-related adaptations in premenopausal women with overweight: a randomized controlled trial. Eur J Nutr. 2026 Oct 7;65(8):275. doi: 10.1007/s00394-026-04131-3.
PubMed 42841999Zawieja E, Mlodzik-Czyzewska M, Chmurzynska A. Betaine supplementation has no effect on sex hormones in premenopausal women with overweight or obesity: A randomized controlled trial. Clin Nutr ESPEN. 2026 Jul 24;75:103610. doi: 10.1016/j.clnesp.2026.103610. Online ahead of print.
PubMed 42498161
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Betaine Supplementation on Body Composition and Lipid Metabolism in a Group of Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT06344377
- Acronym / sponsor ID
- BETadiposeWOMEN
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betaine | Experimental | Dietary Supplement: BetaineBetaine 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- females
- age: 18-45 years
- pre-menopausal
- overweight or obese: BMI >25 kg/m2
- waist circumference > 80 cm
Key exclusion criteria (7 listed)
- males
- age <18 or >45 years
- perimenopausal or postmenopausal
- BMI < 25 kg/m2
- waist circumference < 80 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetaineBetaine supplemented for 8 weeks | Dietary supplement | Betaine |
| PlaceboPlacebo supplementation for 8 weeks | Dietary supplement | Placebo |
Primary outcome
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
Body mass
Time frame: 8 weeks, three measurements: at week 0, 4 and 8
Measured in kg
Waist and hips circumference
Time frame: 8 weeks, three measurements: at week 0, 4 and 8
Measured in cm
Lipid profile
Time frame: 8 weeks, two measurements: at week 0 and 8
Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol
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
3 secondary outcomes
Liver function test
Time frame: 8 weeks, two measurements: at week 0 and 8
Dietary intake
Time frame: 8 weeks, two measurements: at week 0 and 8
sex hormones
Time frame: 8 weeks, two measurements: at week 0 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 42841999Zawieja E, Mlodzik-Czyzewska M, Chmurzynska A. Betaine supplementation modulates mitochondrial and redox-related adaptations in premenopausal women with overweight: a randomized controlled trial. Eur J Nutr. 2026 Oct 7;65(8):275. doi: 10.1007/s00394-026-04131-3.
- Derived from this study: PubMed 42498161Zawieja E, Mlodzik-Czyzewska M, Chmurzynska A. Betaine supplementation has no effect on sex hormones in premenopausal women with overweight or obesity: A randomized controlled trial. Clin Nutr ESPEN. 2026 Jul 24;75:103610. doi: 10.1016/j.clnesp.2026.103610. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agata Chumrzynska principal investigator
Poznan University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betaine in people with Overweight and Obesity, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 8 weeks, three measurements: at week 0, 4 and 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06344377, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.