Obese Women, Perimenopause
Conditions
Keywords
Dandelion, Premenopausal Obese Women, Anti-obesity
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.
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.
Interventions
DRUGXenical
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
DIETARY_SUPPLEMENTThe dandelion extract
The dandelion extract group will receive 500 mg capsules of dandelion leaf extract, given 3 times per day before meals.
Sponsors
Pharos University in Alexandria
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Premenopausal women with obesity. Age between 18-45 years Stable body weight in the past 3 months
Exclusion criteria
Pregnancy Breastfeeding Diabetes Cardiovascular diseases kidney or liver diseases use of medications that affect body weight Smoking Allergy to dandelion or related plants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in body weight | monthly change, assessed up to 3 months |
| Change in fat mass | Monthly change, assessed up to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile | Monthly change, assessed up to 3 months | — |
| CRP | Monthly change, assessed up to 3 months | C-reactive protein |
| TNF-α | Monthly change, assessed up to 3 months | — |
| Appetite Ratings | monthly change, assessed up to 3 months | — |
| IL-16 | Monthly change, assessed up to 3 months | — |
| Glycemic indices | Monthly change, assessed up to 3 months | — |
| IL-6 | Monthly change, assessed up to 3 months | Interelukine 6 |
| Dietary intake via 24-hour recalls | Recorded for patients daily, assessed up to 3 months | — |
Countries
Egypt
Outcome results
None listed