NCT05451927CompletedNot Applicable
A Randomized Double Blind Study to Examine the Effect of Natural Anti-obesity Agent Among Women of Lahore
Hafiza Aisha Sadiqa2 sites in 1 country72 target enrollmentStarted: October 27, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Body weight
Study Overview
Brief Summary
This double-blind randomized placebo-controlled trial will test the hypothesis that administration of Phaseolus Vulgaris supplementation to women in Lahore, Pakistan, who are overweight will induce the weight loss (Primary outcome) and changes in body composition (Waist circumference) secondary outcome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI ranges from 25-40
- •Consistently stable body weight for at least 6 months
- •Good general health
- •No ongoing drug treatment for weight reduction
- •Commitment to avoid any changes in lifestyle throughout the test period
- •Age between 18-45 years
- •Women resident of Lahore
Exclusion Criteria
- •Pregnant or breast-feeding females
- •People with Type 2 diabetes
- •People with any other chronic diseases
- •Weight reduction treatment during the 6 months prior to the study
Arms & Interventions
Placebo
Placebo Comparator
Three oral doses of Placebo daily for 3 months
Intervention: Placebo (Dietary Supplement)
Phaseolus Vulgaris
Experimental
Three oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months
Intervention: Phaseolus Vulgaris (Dietary Supplement)
Outcomes
Primary Outcomes
Body weight
Time Frame: 3 months
change in body weight
Secondary Outcomes
No secondary outcomes reported
Investigators
Hafiza Aisha Sadiqa
Student
University of the Punjab
Study Sites (2)
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