Clinical capabilities Overview

Clinical Research Built for Dietary Supplement Claims and Commercial Strategy

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For more than 20 years, CAHS has partnered with dietary supplement, functional food, and beverage companies to design and execute human clinical trials that generate fit-for-purpose data for structure/function claims, regulatory strategy, scientific publication, and commercial differentiation.

We focus exclusively on natural products and dietary supplements. Our study designs are built around the sponsor’s intended use case, whether that is claim substantiation, safety and tolerability, bioavailability, mechanistic support, retailer scrutiny, or publication-grade evidence.

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Why Sponsors Choose CAHS

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• Exclusive focus on dietary supplement and natural product clinical research

• Single-site execution reduces inter-site variability, simplifies oversight, and accelerates startup

  for healthy-adult supplement studies

• End-to-end execution from protocol design through final report

• Fit-for-purpose physiological and mechanistic endpoints selected to support substantiable

  structure/function claims and withstand scientific and retailer scrutiny

• Sponsor-responsive model that supports efficient budgeting and rapid study refinement

• Experienced scientific and operational team spanning medicine, nursing, nutrition, applied

  physiology, and clinical research operations

• Clean audit history with zero FDA 483s

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Study Types and Product Categories Supported

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CAHS supports clinical programs across a range of dietary supplement use cases and product categories, including:

• Structure/function claim substantiation studies

• Safety and tolerability trials

• Bioavailability and pharmacokinetic studies

• Mechanistic studies using physiological and translational endpoints

• Studies designed to support self-affirmed GRAS and FDA GRAS notification dossiers

• Clinical programs designed to support NDI strategy and supporting documentation

• Manuscript-ready studies intended for peer-reviewed publication

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Core On-Site Clinical Capabilities

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CAHS conducts end-to-end single-site clinical studies designed to generate sponsor-ready human evidence for dietary supplements and natural products. Study execution is managed centrally through protocol development, site operations, participant testing, project management, data capture, and study oversight.

Select specialty services, including certain laboratory analyses, bioanalytical testing, and other highly specialized assessments, may be performed through qualified external partners when required by the study scope. In these cases, CAHS remains the sponsor’s primary point of contact and maintains oversight of vendor coordination, timelines, and data integration.

Capabilities include a range of physiological, functional, and mechanistic assessments selected to match the study objective, target population, and intended claim. Depending on protocol needs, these may include:

• Muscle biopsy and stable isotope infusion methods for mechanistic and protein kinetics research

• Resting metabolic rate and exercise metabolism testing

• DEXA and BIA for body composition, compartment-specific fluid volumes, and bone density

• Strength, power, endurance, and physical performance testing

• Hydration and fluid balance assessment

• Cognitive function, mood, and mental performance outcomes

• Healthy aging, recovery, and quality-of-life endpoints

• Gut health and microbiome-related outcomes

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Study Areas and Product Categories

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• Sports nutrition and exercise performance

• Recovery and muscle health

• Healthy aging

• Cognitive health and mood

• Body composition

• Cardio-metabolic health

• Hydration

• Gut health

• Bone health

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Regulatory and Claim Substantiation Support

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Our studies are designed to generate sponsor-ready data packages that support:

• Structure/function claim substantiation under DSHEA

• Safety and tolerability studies

• Bioavailability and efficacy trials

• Data packages relevant to self-affirmed GRAS and FDA GRAS notification dossiers

• Clinical evidence relevant to NDI strategy and supporting documentation

  All studies are conducted with GCP-aligned procedures, independent IRB oversight, and documentation structured for regulatory, scientific, and commercial use.

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Sponsor Deliverables

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Depending on study scope, CAHS deliverables may include:

• Protocol development

• Study execution and project management

• IRB submission support

• Statistical analysis

• Final clinical study report

• Sponsor-ready executive summaries for internal, legal, and marketing review

• Manuscript and publication support

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Key Performance Metrics

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• 26 years in operation

• 130+ clinical trials completed

• Median enrollment duration: 4 to 8 weeks for standard single-site healthy adult oral

  supplementation studies, typical N≈40–80, excluding niche populations and invasive protocols

• 1,700+ participants in targeted local recruitment database

• Median participant retention rate: >92%+ across completed short-duration efficacy studies

• Median compliance rate: >90%+ in oral supplementation studies

• 300+ peer-reviewed publications

• On-time study delivery rate: >85%+ for low/moderate-complexity studies, where on-time is

  defined as final report delivered by contracted date excluding sponsor-driven change orders