Anti-obesity Effects of Dandelion (Taraxacum Officinale L.)
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2024
CompletedFirst Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedOctober 3, 2024
September 1, 2024
8 months
September 30, 2024
October 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in body weight
monthly change, assessed up to 3 months
Change in fat mass
Monthly change, assessed up to 3 months
Secondary Outcomes (8)
Appetite Ratings
monthly change, assessed up to 3 months
Dietary intake via 24-hour recalls
Recorded for patients daily, assessed up to 3 months
Lipid profile
Monthly change, assessed up to 3 months
CRP
Monthly change, assessed up to 3 months
TNF-α
Monthly change, assessed up to 3 months
- +3 more secondary outcomes
Study Arms (2)
Control group
ACTIVE COMPARATORThe 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
EXPERIMENTALThe 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.
Interventions
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 extract group will receive 500 mg capsules of dandelion leaf extract, given 3 times per day before meals.
Eligibility Criteria
You may qualify if:
- Premenopausal women with obesity. Age between 18-45 years Stable body weight in the past 3 months
You may not qualify if:
- Pregnancy Breastfeeding Diabetes Cardiovascular diseases kidney or liver diseases use of medications that affect body weight Smoking Allergy to dandelion or related plants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- October 6 Universitylead
- Pharos University in Alexandriacollaborator
Study Sites (1)
October 6 University Hospital
Giza, 12566, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
September 30, 2024
First Posted
October 3, 2024
Study Start
January 5, 2024
Primary Completion
September 7, 2024
Study Completion
September 7, 2024
Last Updated
October 3, 2024
Record last verified: 2024-09