Nutrition trials, GCP-grade by default.
A nutrition team that runs studies the way clinical research is run. Functional food and ingredients, FSMP, infant and early-life nutrition, medical foods, botanicals and novel food, all designed to ICH E6(R3) conduct. Ethics committees and competent authorities increasingly expect GCP-grade rigour on nutrition trials, and many sponsors discover this only after a study that no longer serves the claim.
Nutrition science sits between consumer speed and clinical rigour.
Food, supplements, ingredients, botanicals, novel food and FSMP must meet real scientific and regulatory expectations, efficacy, tolerability, compliance, across healthy, sub-healthy (subclinical, at-risk, borderline) and diseased populations. Each state needs a different recruiting channel, and standard sites rarely reach any of them well. And when ethics committees ask for GCP conduct, university and hospital teams, the usual comparators here, are rarely formally trained on GCP. The study completes; the evidence does not survive review.
One expert partner across the whole nutrition span.
- GCP-grade conductICH E6(R3) applied to nutrition trials, consent, monitoring, source data, safety and TMF, so the evidence survives ethics and authority review.
- FSMP & medical foodsStudies designed to the evidence bar that food for special medical purposes requires.
- Infant & early-life nutritionSpecialised expertise and ethical recruitment for sensitive populations.
- Ingredients, botanicals & novel foodSubstantiation for functional ingredients, botanicals and novel food, from bioavailability to health effect.
- Three health states, one protocolRecruit healthy, sub-healthy and diseased participants in the same study, through pharmacies, HCPs, associations, digital communities and GCP sites.
- Nutrition substantiationClaim support for functional foods and supplements, real-world and defensible.
- Safety, tolerability & nutrivigilanceTolerability, digestive comfort, safety and post-market nutrivigilance / food safety surveillance for foods, ingredients, botanicals and FSMP.
- Compliance captureLucaH® eDiaries capture intake, adherence and tolerability in everyday life.
- Pharmacy & online channelsActivate studies through community and online pharmacies alongside GCP centres, where consumers actually buy and use nutrition products.
The scientific rationale.
- Food and nutrition products require human evidence due to biological variability and population-level exposure.
- Nutritional effects are modulated by diet, lifestyle, microbiome and genetics.
- Small effect sizes require well-designed human studies, and real-world consumption differs from controlled-trial conditions.
- Post-market evidence is essential to demonstrate sustained physiological benefit.
Nutrition-specific human research, aligned with EFSA and international guidelines.
Interventional evidence
- Randomised controlled trials (parallel or crossover)
- Short- and long-term dietary intervention studies
- Mechanistic and biomarker-driven investigations
- Tolerance and safety studies in healthy, sub-healthy and diseased populations
Observational & epidemiological
- Prospective cohort and longitudinal dietary studies
- Consumption-pattern and adherence assessments
- Real-world effectiveness of nutritional interventions
- Health-claim substantiation bridging controlled and real-world data
Where nutrition meets real science.
- A genuine core domain, recruitment reach into the exact populations nutrition studies need.
- Bridges consumer speed and clinical rigour in one ecosystem.
- Fully GCP-trained CRO, the requirement most nutrition comparators (universities, hospitals) don't meet.
- AIRA designs endpoints that satisfy regulators and reviewers.
- Connects naturally to CHC and RWE as your evidence needs grow.
Beyond classic GCP hospital centres.
For non-Rx nutrition, we activate studies through community and online pharmacies, territorial HCPs and home settings, beyond classic GCP hospital centres.
Nutrition trials, run to clinical standards.
On food and nutrition, we compete with universities and hospitals. We win on GCP.
Ethics committees and competent authorities increasingly demand ICH E6(R3) conduct on nutrition trials. It is a requirement most sponsors don't hear about, until the study is already at risk.
- What ethics asks forGCP-grade conduct
ICH E6(R3) applied to nutrition trials: informed consent, protocol adherence, monitoring, verified source data, safety reporting, TMF and audit trail.
- What sponsors missThe quiet requirement
Nutrition studies are often run by academic teams new to GCP. GCP-grade conduct is what makes the completed study hold up in ethics and authority review.
- What Evidilya deliversA GCP-trained CRO
Protocol, monitoring, data, safety and TMF all run to the bar regulators and ethics committees expect, with the same rigour a pharma trial gets.
We design evidence against the framework that regulates your claim.
The design of a study, endpoints, population, comparator, statistical plan, is a function of which authority will read the evidence. We start there.
- EFSA · Reg (EC) 1924/2006Nutrition & health claims, EU
Art. 13.1 generic function · Art. 13.5 new science · Art. 14 disease risk-reduction and children's development.
EvidenceHuman intervention studies with pre-specified endpoints, dose-response, characterised food matrix. - FDA · DSHEA / 21 CFR 101Structure-function & qualified health claims, US
Structure-function statements for supplements · Qualified Health Claims where evidence is emerging.
EvidenceSubstantiation dossier: RCTs, mechanism, safety, characterisation, plus notification workflow. - Codex · CXG 23-1997General principles for health claims, global
Nutrient content, comparative, function and reduction-of-disease-risk claims across Codex member states.
EvidenceSystematic review + weight-of-evidence, aligned with local competent authority. - ASA · CAP Code / FTC Act §5Advertising substantiation, UK & US
Truthful, non-misleading claims in advertising · 'competent and reliable scientific evidence' standard.
EvidenceHuman data prioritised, claim-to-evidence mapping, disclaimers where warranted.
The shortest route to nutrition evidence.
Dietary behaviour, compliance and perceived outcomes measured with psychometrically sound instruments, when a full RCT is not (yet) the right answer.
Evidence builds medical equity, and the right to talk to clinicians.
In consumer health and nutrition, evidence is a growth asset as much as a regulatory one. It earns HCP attention, opens scientific dialogue and lets the brand carry new medical content into practice, starting a category conversation.
Medical equity
A defensible body of evidence that positions the product inside a clinical conversation.
Scientific authority
Peer-reviewed publications, congress data and KOL endorsement that let the brand co-author the category narrative.
HCP engagement licence
Evidence medical affairs, MSLs and reps can actually share, turning detailing into education HCPs read, cite and recommend.
Delivered through AIRA, advisory boards & KOL and publication & scientific communication.
One study, three health states.
Unlike prescription drug trials, nutrition and consumer-health research routinely spans healthy, sub-healthy (subclinical, at-risk, borderline, self-perceived) and diseased participants. Each state has its own eligibility criteria, endpoints, ethics posture, and, critically, its own recruiting channel. Reaching only one of them narrows the science.
Across the age continuum too, from paediatric cohorts and care-partners to adults and seniors, with age-appropriate consent, endpoints and, where needed, proxy access on ECS® so a trusted caregiver can complete tasks on the participant's behalf.
Substantiate everyday benefit, tolerability, preference and habit-of-use.
General adult consumers · athletes · targeted diets · early-life & healthy ageing.
Digital communities · PHYGITAL-CROWD · online pharmacies · at-home / D-T-P with nurse visits.
Show effect on subclinical, at-risk or self-perceived conditions where a drug is not indicated.
Borderline dyslipidaemia · low-grade fatigue · digestive discomfort · perimenopause · sarcopenic-obese · IBS-lite · mild sleep or mood complaints.
Community & online pharmacies · territorial HCPs · digital communities · patient-like associations.
Generate regulatory-grade evidence for FSMP, medical foods, adjuvant CHC or condition-specific claims.
Diagnosed patients on chronic therapy · rare metabolic disorders · post-acute or recovering populations.
GCP sites · specialist HCPs · patient associations · hospital pharmacies · home visits.
Six channels, one operating layer.
PHYGITAL-CROWD activates the right mix per protocol, orchestrated on ECS® so provenance, consent and audit travel with the participant.
- GCP sites
- Community & online pharmacies
- Territorial HCPs
- Patient associations
- Digital communities · PHYGITAL-CROWD
- At-home · D-T-P & home visits
Prove your nutrition claim.
From bioavailability to health effect, we design the human study your claim needs, and run it where consumers actually live.