Obese WomenNCT06625736
Anti-obesity Effects of Dandelion (Taraxacum Officinale L.)
A study testing Xenical and The dandelion extract in people with Obese Women and Perimenopause, run by October 6 University at 1 site in Egypt.
Trial summary
The study investigates the effectiveness of the natural product Dandelion in treating obesity in premenopausal women through a randomized interventional trial, measuring various parameters and biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obese Women, Perimenopause
- What is being tested?
- Xenical and The dandelion extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2024to 7 Sep 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women with obesity. Age between 18-45 years Stable body weight in the past 3 months
Who cannot join
- Pregnancy Breastfeeding Diabetes Cardiovascular diseases kidney or liver diseases use of medications that affect body weight Smoking Allergy to dandelion or related plants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-obesity Effects of Dandelion (Taraxacum Officinale L.) in Premenopausal Obese Women: Impacts on Appetite, Energy Intake and Lipid Metabolism
The study investigates the effectiveness of the natural product Dandelion in treating obesity in premenopausal women through a randomized interventional trial, measuring various parameters and biomarkers.
Read the detailed description
The study aims to explore the anti-obesity effects of dandelion supplementation in premenopausal obese women. The research will measure changes in appetite, energy intake, body weight, composition, lipid profile, and inflammatory markers, providing evidence of dandelion\'s efficacy as an anti-obesity phototherapy. The randomized interventional trial will measure multiple parameters and biomarkers.
- Conditions
- Obese Women, Perimenopause
- Being tested
- Xenical, The dandelion extract
- Keywords
- Dandelion, Premenopausal Obese Women, Anti-obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenicalDrug
The Xenical group will receive identical capsules 120mg (one capsule) to be taken three times daily with meals, equaling 360mg total daily dose, which aligns with the usage in adult female patients
The dandelion extractDietary supplement
The dandelion extract group will receive 500 mg capsules of dandelion leaf extract, given 3 times per day before meals.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The Xenical group:60 patients will receive identical capsules of 120mg (one capsule) to be taken three times daily with meals and for 12 weeks, equaling 360mg total daily dose. Receives: Drug: Xenical |
| The dandelion extract group | Experimental | The dandelion extract group: 60 patients will receive 500 mg capsules of dandelion leaf extract, given 3 times per day before meals and for 12 weeks. Receives: Dietary Supplement: The dandelion extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Measured: monthly change, assessed up to 3 months
Change in fat mass
Measured: Monthly change, assessed up to 3 months
Secondary outcomes (8)
Appetite Ratings
Measured: monthly change, assessed up to 3 months
Dietary intake via 24-hour recalls
Measured: Recorded for patients daily, assessed up to 3 months
Lipid profile
Measured: Monthly change, assessed up to 3 months
CRP
C-reactive protein
Measured: Monthly change, assessed up to 3 months
TNF-α
Measured: Monthly change, assessed up to 3 months
IL-6
Interelukine 6
Measured: Monthly change, assessed up to 3 months
IL-16
Measured: Monthly change, assessed up to 3 months
Glycemic indices
Measured: Monthly change, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start5 Jan 2024
- Primary completion7 Sep 2024
- Study completion7 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese WomenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Pharos University in Alexandria
- Responsible party
- Principal investigator, rabab ahmed mohamed, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625736
- Sponsor's protocol ID
- Dandelion effect on obesity
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-obesity Effects of Dandelion (Taraxacum Officinale L.) in Premenopausal Obese Women: Impacts on Appetite, Energy Intake and Lipid Metabolism
- ClinicalTrials.gov ID
- NCT06625736
- Acronym / sponsor ID
- Dandelion effect on obesity
- Conditions
- Obese Women, Perimenopause
- Keywords
- Dandelion, Premenopausal Obese Women, Anti-obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Pharos University in Alexandria
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 7 Sep 2024 (actual)
- Study completion
- 7 Sep 2024 (actual)
- First posted
- 3 Oct 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.
The study investigates the effectiveness of the natural product Dandelion in treating obesity in premenopausal women through a randomized interventional trial, measuring various parameters and biomarkers.
Detailed description
The study aims to explore the anti-obesity effects of dandelion supplementation in premenopausal obese women. The research will measure changes in appetite, energy intake, body weight, composition, lipid profile, and inflammatory markers, providing evidence of dandelion\'s efficacy as an anti-obesity phototherapy. The randomized interventional trial will measure multiple parameters and biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: XenicalThe Xenical group:60 patients will receive identical capsules of 120mg (one capsule) to be taken three times daily with meals and for 12 weeks, equaling 360mg total daily dose. |
| The dandelion extract group | Experimental | Dietary Supplement: The dandelion extractThe dandelion extract group: 60 patients will receive 500 mg capsules of dandelion leaf extract, given 3 times per day before meals and for 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premenopausal women with obesity. Age between 18-45 years Stable body weight in the past 3 months
Key exclusion criteria (1 listed)
- Pregnancy Breastfeeding Diabetes Cardiovascular diseases kidney or liver diseases use of medications that affect body weight Smoking Allergy to dandelion or related plants
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 |
|---|---|---|
| XenicalThe Xenical group will receive identical capsules 120mg (one capsule) to be taken three times daily with meals, equaling 360mg total daily dose, which aligns with the usage in adult female patients | Drug | Control group |
| The dandelion extractThe dandelion extract group will receive 500 mg capsules of dandelion leaf extract, given 3 times per day before meals. | Dietary supplement | The dandelion extract group |
Primary outcome
Changes in body weight
Time frame: monthly change, assessed up to 3 months
Change in fat mass
Time frame: Monthly change, assessed up to 3 months
8 secondary outcomes
Appetite Ratings
Time frame: monthly change, assessed up to 3 months
Dietary intake via 24-hour recalls
Time frame: Recorded for patients daily, assessed up to 3 months
Lipid profile
Time frame: Monthly change, assessed up to 3 months
CRP
Time frame: Monthly change, assessed up to 3 months
TNF-α
Time frame: Monthly change, assessed up to 3 months
IL-6
Time frame: Monthly change, assessed up to 3 months
IL-16
Time frame: Monthly change, assessed up to 3 months
Glycemic indices
Time frame: Monthly change, assessed up to 3 months
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 3 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenical and The dandelion extract in people with Obese Women and Perimenopause, run by October 6 University at 1 site in Egypt.
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 1 inclusion and 1 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 3 Oct 2024. 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 Egypt. 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. 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?
Changes in body weight (time frame: monthly change, assessed up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.