A supplement study with a blood metabolite endpoint, daily intake and wellbeing outcomes needs more than a survey tool. Capture ties product lot, intake diary, blood results and safety checks to each participant, with a free sandbox to build and test it first.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Daily intake diary (demo study)
Participant phone view · Day 21
Did you take today's capsules?
TAKENTime taken
TAKTIMTaken with food?
FOODFLEnergy today
ENERGYAny new symptoms?
AEYNSupplement trial data in brief
The study type
NAD+ precursors such as nicotinamide riboside and nicotinamide mononucleotide are widely discussed in longevity research and are sold as supplements. Whatever you believe about them, a study of one has a recognisable shape. The intervention is an oral product taken daily for weeks or months. The mechanistic endpoint is often a blood level of NAD-related metabolites, measured at baseline and again later. The practical endpoints are what people feel and do: energy, sleep, recovery and function. And a good study needs product traceability, so every participant's capsules can be linked to a manufacturing lot.
This page is specific to that pattern. If your study is a general supplement or nutrition study, our pages on EDC for supplement clinical trials, clinical trial software for nutrition research and supplement claim substantiation study software cover the broader ground, including how labelling and claims relate to evidence. Here, we focus on what the EDC must capture when the endpoint is a blood metabolite and the exposure is a daily intake.
Data model
| Data group | What is recorded | How it fits in Capture |
|---|---|---|
| Product and lot | Product code, lot number, expiry, bottles issued and returned | Site form on each dispensing visit; kit dispensing and accountability for blinded supply |
| Daily intake | Taken or not, time, with or without food, reason if missed | Participant diary on the phone with a reminder ladder; completion windows |
| Adherence | Percentage of days taken, pill count against diary | Calculated fields from diary rows and returned count; edit checks on large differences |
| Blood metabolites | NAD-related metabolite levels, assay batch, collection time and fasting state | Result form with units; batch and timing fields in the same record |
| Routine safety labs | Liver, kidney, glucose, lipids and so on | Laboratory form with reference ranges and auto-queries |
| Wellbeing outcomes | Energy, fatigue, sleep, mood, recovery | ePRO templates such as the sleep diary, fatigue log and recovery tracker |
| Function measures | Grip strength, walking tests | Site forms, repeated trials as table rows |
| Safety | Adverse events, concomitant medicines and supplements | Adverse event form, SAE workflow and a repeating concomitant table |
Traceability
In a placebo-controlled supplement study, active and placebo capsules look the same, so the lot number is the link to what was actually taken. Record the lot on every dispensing visit, with expiry and quantities. If a lot is ever questioned, you can list every participant who received it and what happened to them. Blinded roles never receive treatment-arm values; the lot code can be recoded so that it does not reveal the arm to people who must remain unaware. The IMP inventory and drug accountability page describes kit dispensing and returns, and randomization software covers allocation and stratification.
Supplements also carry a data risk that drugs rarely do: participants may take other products on their own. Ask about every supplement, not just prescribed medicines, on a repeating concomitant table, and repeat the question at each visit. A participant who starts a second NAD-related product mid-study changes the exposure, and the analysis needs to know.
Every feature is free to test: forms, ePRO, randomisation and the audit trail. No credit card, and you pay only when you go live.
Setup
Choose the primary blood measure, the secondary wellbeing outcomes and the timing of each draw and each diary.
Record the product, lot, expiry and quantity issued and returned at each dispensing visit.
Short phone entries with a reminder ladder, quiet hours and a completion window rule. See ePRO compliance reminders.
A blood metabolite form with batch fields, a safety lab form with ranges, and the adverse event form.
Adapt the sleep diary, fatigue log and recovery tracker, or add a validated scale with its licence handled according to its terms.
Enter sample data, break your own edit checks, approve the forms and open enrolment.
Outcomes
Wellbeing outcomes are noisy, so design them to be small and frequent. A one-minute daily entry on energy, sleep and mood beats a long monthly questionnaire for recall, and the same entry can carry the intake question so participants answer once. The phone-browser link means no app to install, and QR code enrolment works for participants recruited at events or clinics. See ePRO software for clinical trials for the feature set.
Wearables add sleep, heart-rate variability and activity. Capture connects wearables natively: the study team enables a device per study, the participant connects their own account, and data sync with a last-sync time and a disconnect control. Oura is the device named today. Add the wearable data sharing consent template to your consent set, and read EDC for wearable device studies to decide which sensor variables are endpoints and which are exploratory. For wider healthy-ageing designs see EDC for longevity clinical trials.
Before you start
Lot, expiry and quantities on every dispensing record.
Reminders, quiet hours and completion windows verified on a real phone.
Participant code, sample ID, collection date, assay batch and result columns.
A repeating table for every product the participant takes, repeated at each visit.
Adverse event definitions and the SAE route tested in the sandbox.
Your regulatory adviser has checked how study results may be described.
Claims and responsibilities
Rules about what a supplement may say about health differ by country, and a study does not by itself authorise a claim. This page is not legal or regulatory advice; talk to your regulatory adviser about how results can be described and whether the study needs ethics approval in your jurisdiction. Capture provides 21 CFR Part 11-aligned controls, a field-level audit trail and role-based access, and the sponsor remains responsible for validated use. The audit trail records timestamp, user, old value, new value and reason for each change, and cannot be altered through the interface. Our audit trail software page explains what that means in practice.
Yes. Participants answer a short phone diary with reminders and completion windows, and the site records product lot, quantities issued and returned at each dispensing visit.
Yes. Results are stored on a form with typed fields, units and ranges, with batch and collection time recorded in the same record. Capture records the results your laboratory returns; it does not run the assay.
Randomisation assigns arms and blinded roles never receive treatment-arm values, enforced by masked database views. Lot codes can be handled so they do not reveal the arm.
No. It is data capture software and makes no health or efficacy claim about any supplement. This page is not legal or regulatory advice.
Yes. Questionnaires open in the phone browser through a secure link or a QR code, with no app and no password.
The sandbox is free with every feature, no credit card and no time limit. You pay only once the study goes live with real participants.
Keep exploring
EDC for supplement clinical trials
The general supplement view.
Supplement claim substantiation software
Evidence behind claims.
Clinical trial software for nutrition research
Diet and nutrition studies.
IMP inventory and accountability
Lots, kits and returns.
EDC for longevity clinical trials
Healthy-ageing designs.
EDC for wearable device studies
Sensor data in the study record.
Free sandbox with every feature. No credit card, and you pay only when you go live.