Trial to Examine the Effect of Natural Anti- Obesity Agent (Phaseolus Vulgaris) Among Women of Lahore

NCT05451927 | Completed

• 1 other identifier: RCT012022
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity

Keywords

Weight loss

Outcome Measures

Primary Outcomes (1)

• Body weight

  change in body weight

  3 months

Study Arms (2)

Phaseolus Vulgaris

EXPERIMENTAL

Three oral doses of 1000 mg Phaseolus Vulgaris daily for 3 months

Dietary Supplement: Phaseolus Vulgaris

Placebo

PLACEBO COMPARATOR

Three oral doses of Placebo daily for 3 months

Dietary Supplement: Placebo

Interventions

Phaseolus Vulgaris DIETARY_SUPPLEMENT

Weight loss

Phaseolus Vulgaris

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women, resident of Lahore, Pakistan
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hafiza Aisha Sadiqa: lead
• University of the Punjab: collaborator

Study Sites (2)

Akhuwat Medical Centre

Lahore, Punjab Province, Pakistan

Location

Niazi Medical Centre

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Aisha Sadiqa, M.Phil

  University of the Punjab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 11, 2022
• Study Start: October 27, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Till 10 years after completion of trial
• Access Criteria: on request through email and after Data Transfer Agreement and IRB approval

Locations

PA (2)