Anti-obesity Effects of Dandelion (Taraxacum Officinale L.)

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.

Study Overview

• Status: Completed
• Conditions: Perimenopause; Obese Women
• Intervention / Treatment: Drug: Xenical; Dietary supplement: The dandelion extract

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12566
    • October 6 university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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.	Drug: Xenical; 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
Experimental: The dandelion extract group; 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.	Dietary supplement: The dandelion extract; The dandelion extract group will receive 500 mg capsules of dandelion leaf extract, given 3 times per day before meals.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	C-reactive protein	Monthly change, assessed up to 3 months
TNF-α		Monthly change, assessed up to 3 months
IL-6	Interelukine 6	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

Collaborators and Investigators

• Sponsor: October 6 University
• Collaborators: Pharos University in Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Actual): September 7, 2024
• Study Completion (Actual): September 7, 2024

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Dandelion; Premenopausal Obese Women; Anti-obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Anti-Obesity Agents; Orlistat
• Other Study ID Numbers: Dandelion effect on obesity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes