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Backed by Science: Clinically Validating a Powerful Metabolism Booster

A U.S.-based nutraceutical startup developing a natural metabolism booster and weight management supplement aimed to clinically validate its product to support claims of increased fat oxidation, appetite regulation, and energy improvement. The trial was a key step toward securing retail partnerships and substantiating health claims under FTC and FDA guidelines.

Client Challenges

  • Conduct a 12-week, placebo-controlled, double-blind trial in overweight and mildly obese adults
  • Capture both objective biomarkers (e.g., BMI, body fat %, resting energy expenditure) and subjective outcomes (appetite, satiety, mood)
  • Deliver regulatory-ready results within a short commercial launch timeline
  • Meet expectations for FTC-compliant substantiation for weight loss claims
  • Ensure high compliance and retention in a lifestyle-based protocol

Clinvigilant Research Solution

Regulatory & Study Design Support

  • Developed a clinical protocol aligned with FDA dietary supplement guidance
  • Assisted in defining primary and secondary endpoints including:
  • Change in body weight, BMI, waist circumference
  • Appetite and satiety ratings (via validated scales)
  • Resting metabolic rate (via indirect calorimetry)
  • Supported IRB approval, created GCP-compliant informed consent forms, and handled FDA DSHEA guidance alignment

Participant Recruitment & Lifestyle Tracking

  • Designed a digital recruitment campaign targeting adults with BMI 25–32 using health-focused communities and primary care partners
  • Screened and enrolled 180 participants in 6 weeks
  • Integrated wearable fitness tracker data and digital food diaries via ePRO system to monitor lifestyle adherence

Clinivigilant EDC + Monitoring

  • Deployed EDC with integrated ePRO to collect:
  • Anthropometric measurements
  • Self-reported dietary intake and appetite
  • Product adherence and AEs
  • Real-time dashboards and site monitoring ensured protocol compliance and data completeness
  • Conducted centralized monitoring and source verification with CRA oversight

Data Management & Submission Prep

  • Delivered complete, locked database within 4 weeks of study close
  • Prepared clinical study report (CSR) for FTC substantiation
  • Provided data visualization assets for marketing claims review

Outcomes

180

Total Participants Enrolled

92%

Completion
Rate

<2%, all mild

AE
Incidence

+11%

(active group)

Increase in Resting Energy Expenditure

6.1% of body weight

(vs. 1.8% placebo)

Average Weight Loss (Active Group)

Delivered 3 weeks post DB lock

FTC Substantiation Package

Client Testimonial

VP, Scientific Affairs
U.S. Nutraceutical Brand

“Clinivigilant’s expertise in supplement trials, data integrity, and speed made all the difference. We now have defensible data that sets us apart in the crowded weight loss category.”

Value Delivered

With deep therapeutic and regulatory knowledge in weight management,
Clinivigilant enabled this client to generate real-world evidence, navigate compliance challenges, and prepare for multi-channel commercial rollout — all within timeline and budget.

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