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Plant-Based Supplement for Body Fat

N/A
Recruiting
Research Sponsored by Brightseed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, ≥18 years of age at visit 1 (week -1).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 4, 8, 12, 16, 20, and 24 weeks
Awards & highlights

Summary

"This trial aims to see if a dietary supplement with plant-based phenolics can reduce body fat in healthy adults with risk factors like high BMI, dyslipidemia, or pre-diabetes. Researchers want

Who is the study for?
Adults over 18 with a BMI of 28-35, dyslipidemia (cholesterol issues), or pre-diabetes are eligible for this trial. They must have stable medication use for the past 90 days and not be current tobacco or nicotine users. Participants should maintain their current diet and supplement intake throughout the study.
What is being tested?
The trial is testing how effective a dietary supplement with plant derived phenolics is at reducing body fat in adults at risk due to high BMI, dyslipidemia, or pre-diabetes. It compares two doses of the supplement against a placebo treatment.
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to new dietary supplements such as digestive discomfort, allergic reactions, or changes in appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 4, 8, 12, 16, 20, and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 4, 8, 12, 16, 20, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body fat mass
Secondary outcome measures
ALT
AST
Abdominal circumference
+36 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Active low dose of plant derived phenolicsActive Control1 Intervention
Active low dose of plant derived phenolics via 1 capsule/day
Group II: Active high dose of plant derived phenolicsActive Control1 Intervention
Active high dose of plant derived phenolics via 1 capsule/day
Group III: Placebo treatmentPlacebo Group1 Intervention
Placebo treatment (Microcrystaline cellulose): 1 capsule/day

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Who is running the clinical trial?

BrightseedLead Sponsor
5 Previous Clinical Trials
412 Total Patients Enrolled
~56 spots leftby Dec 2024
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