To Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
1 other identifier
interventional
97
1 country
1
Brief Summary
CitruSlim® can promote healthy weight loss by promoting anabolic state during weight loss programs, prevent the body from storing fat, reduce appetites and maintain healthy cholesterol and blood glucose level during weight loss program. This study focuses to prove the efficacy and safety of the product in a population of overweight and obese individual.
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 Jun 2019
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
First Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedStudy Start
First participant enrolled
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2020
CompletedApril 12, 2021
June 1, 2019
12 months
May 7, 2019
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Change in body fat percent Body Mass Index (kg/m2)
Assessed using DEXA
16 weeks.
Change in Lean Body Mass (g)
Assessed using DEXA
16 weeks
Change in Body Fat (%)
Assessed using DEXA
16 weeks
Change in Fat Free Mass (g)
Assessed using DEXA
16 weeks
Study Arms (3)
Citrus flavonone-O-glycosides (Low dose)
EXPERIMENTALCitrus flavonone-O-glycosides (High dose)
EXPERIMENTALMicrocrystaline Cellulose- 400mg
PLACEBO COMPARATORInterventions
Low Dose of 200 mg
High Dose of 400 mg
Placebo (Microcrystalline Cellulose) of 400 mg
Eligibility Criteria
You may qualify if:
- Male and female participants with the age of ≥18 and ≤ 60 years of age.
- BMI of ≥25 - ≤ 35 kg/m2
- Waist circumference:India: Men: \> 94 cm (37 inches), Women: \>80 cm (31.5 inches) USA: Men: \> 102 cm (40 inches), Women: \>89 cm (35 inches)
- Triglycerides \>150 mg/dL
- Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg
- Fasting blood glucose ≥ 100 mg/ dl
- Low HDL level: Men: \< 40 mg/dL, Women: \< 50 mg/dL
- Ready to give voluntary, written, informed consent to participate in the study.
You may not qualify if:
- Participants meeting any of the following criteria will be excluded from the trial:
- Current smoker.
- Inability to walk independently.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Neurological conditions causing functional or cognitive impairments
- Unwillingness or inability to be randomized to one of three intervention groups.
- Bilateral hip replacements.
- Exposure to any non-registered drug product within 3 months prior to the screening visit.
- Unable/unwillingness to complete study specific diaries (digital/paper-based).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reveal
Bradenton, Florida, 34205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2019
First Posted
June 4, 2019
Study Start
June 4, 2019
Primary Completion
May 30, 2020
Study Completion
September 18, 2020
Last Updated
April 12, 2021
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share