Tier 3 — preclinical

Effects of a Multi-Ingredient Longevity Formulation (DoNotAge®) on Subjective Well-Being, Fatigue, and Gastrointestinal Tolerability: A 60-Day Randomised, Double-Blind, Placebo-Controlled Trial

DoNotAge.org Research Team
DoNotAge.org, Health Research Organisation — sponsor-published original research article 2026 Clinical Trial 1, published on the DoNotAge Routine science hub

Bibliography

Funding
The study was conducted and published by DoNotAge.org, the manufacturer of the tested product. No external funding source is declared. The report states the protocol was designed in accordance with the Declaration of Helsinki and that informed consent was obtained from all participants prior to enrolment.
Competing interests
The trial was designed, funded, conducted, analysed and published by DoNotAge.org, the manufacturer of the tested product. No independent sponsor or external funder is declared.

Study snapshot

Design60-day, single-centre, randomised, double-blind, placebo-controlled, parallel-group trial conducted at a clinical site in Dubai, United Arab Emirates.
ModelGenerally healthy adults aged 30–65 years in self-reported good general health. Excluded: current prescription medication for chronic conditions, known gastrointestinal disorders, current supplementation with any study ingredient, pregnancy or breastfeeding.
Samplen=30 enrolled (15 treatment, 15 placebo); n=28 completers (15 treatment, 13 placebo) after two placebo-arm withdrawals.
InterventionOne DoNotAge® sachet daily with water, preferably in the morning, versus a visually and organoleptically matched placebo sachet, for 60 days.
Duration60 days, with assessment at baseline (day 0), midpoint (day 30) and endpoint (day 60).
EndpointsPrimary: WHO-5 Well-Being Index percentage score (MCID 10 points, two-week recall); Primary: FACIT-Fatigue total score, version 4 (MCID 3-4 points, seven-day recall); Secondary: Gastrointestinal Symptom Rating Scale across five domains plus nausea; Secondary: willingness to continue at day 60; Secondary: Patient Global Impression of Change at day 60; Prespecified responder analysis against MCID thresholds

What the study showed, in plain terms

Almost no all-in-one longevity powder has ever been tested as a finished product. The industry norm is to cite research on individual ingredients and let the reader assume it transfers to the blend. DoNotAge is one of a small number of brands in this comparison that ran a controlled trial on the actual sachet people buy, and this 60-day study is the larger of its two.

Thirty generally healthy adults aged 30 to 65 were randomly assigned at a clinical site in Dubai to one DoNotAge sachet daily or a placebo matched for appearance, taste and smell. Neither participants nor investigators knew which was which. Two primary outcomes were fixed in advance, both validated instruments in wide clinical use: the WHO-5 Well-Being Index and the FACIT-Fatigue scale. Both have an established minimally clinically important difference, so the bar for a meaningful result was set before the data existed rather than after.

On WHO-5, the treatment group rose from 34.4 percent at baseline to 70.4 percent at day 60 — from a level the instrument's literature treats as low mood warranting further assessment, up into the good wellbeing range. Placebo moved from 33.8 to 43.7. The between-group difference in change was 26.2 percentage points against an MCID of 10. On FACIT-Fatigue, treatment improved 4.9 points against an MCID of 3 to 4, while placebo moved -0.1. Gains appeared at day 30 and continued to day 60 rather than spiking and fading. Every treatment participant crossed the responder threshold on both instruments; on placebo, 2 of 13 crossed it on WHO-5 and none on fatigue.

Gastrointestinal tolerability was the secondary endpoint, and it returned a clean null: no domain of the GSRS moved in either arm. For a formula carrying fifteen actives at meaningful doses in a single sachet, a null tolerability result is a genuinely useful finding.

The honest framing is that this is promising early finished-product evidence rather than proof. The sample is 28 completers. The analysis is per-protocol, not intention-to-treat. Both primary outcomes are how people say they feel, not a measured biomarker. The exact doses used in the study sachet are withheld as proprietary. The report is published by the manufacturer rather than a journal, and in the version reviewed the ethics-approval line still read "to be confirmed" rather than naming the committee. Those are the things a larger, externally reviewed replication would need to close — and the report itself calls for exactly that.

Key findings

  • WHO-5 percentage score rose from 34.4 (SD 4.5) at baseline to 53.3 (SD 6.7) at day 30 and 70.4 (SD 7.1) at day 60 in the treatment group, versus 33.8 to 42.2 to 43.7 (SD 11.7) on placebo.
  • Between-group difference in WHO-5 change was +26.2 points (treatment +36.0, SD 6.2; placebo +9.8, SD 11.6), Cohen's d = 2.87, confirmed by Mann-Whitney U at p = 0.0002. MCID is 10 points.
  • FACIT-Fatigue total improved +4.9 (SD 0.4) on treatment versus -0.1 (SD 0.3) on placebo, a between-group difference of +4.9 with Cohen's d = 15.47. MCID is 3-4 points. Higher scores indicate less fatigue.
  • Responder analysis against prespecified MCID thresholds: 15 of 15 treatment participants met the WHO-5 threshold versus 2 of 13 on placebo; 15 of 15 met the FACIT-Fatigue threshold versus 0 of 13 on placebo.
  • Baseline balance on both primary endpoints was close: WHO-5 34.4 versus 33.8 (p = 0.73); FACIT-Fatigue 26.0 versus 26.0 (p = 1.00).
  • All six GSRS measures — abdominal pain, reflux, indigestion, diarrhoea, constipation and nausea — showed a change of 0.0 in both arms over 60 days, indicating no gastrointestinal adverse effect.
  • Willingness to continue at day 60 was 4.5 (SD 0.5) on treatment versus 2.8 (SD 0.8) on placebo, Cohen's d = 2.55; 53 percent of treatment participants selected "Definitely yes" and 47 percent "Probably yes", with none unwilling.
  • Patient Global Impression of Change was 4.5 (SD 0.6) on treatment versus 2.9 (SD 1.0) on placebo, Cohen's d = 1.93; 53 percent reported feeling "Much better" and 40 percent "Somewhat better", against 62 percent reporting "About the same" on placebo.
  • The report notes the placebo WHO-5 gain was driven largely by one atypically large placebo responder, with high variability (SD 11.6) and minimal change in the majority.

What this study can and cannot tell us

The report lists its own limitations, and they are the right ones. Sample size is 28 completers and the authors state the results should be interpreted as hypothesis-generating pending a larger confirmatory trial.

The analysis is per-protocol on completers rather than intention-to-treat, following two placebo-arm withdrawals that left a 15:13 imbalance. Minor baseline imbalances were present in three GSRS domains — reflux, diarrhoea and constipation — though not in the primary endpoints.

Both primary outcomes are patient-reported. WHO-5 and FACIT-Fatigue are validated instruments with established MCIDs, which is a real methodological strength, but they measure how participants say they feel rather than an objective biomarker. The report recommends objective biomarkers of ageing in future trials.

Exact ingredient doses in the study sachet are described as proprietary, which the report acknowledges limits full reproducibility. Note that the retail product page does publish all fifteen headline doses; it is the study product composition table that withholds them.

The effect sizes are very large — Cohen's d of 2.87 on WHO-5 and 15.47 on FACIT-Fatigue. Values of that magnitude in a small single-site trial usually indicate low within-group variance rather than an effect of that true size, and would be expected to attenuate substantially in a larger, more heterogeneous sample. They should be reported as observed and not extrapolated.

The trial was designed, funded, conducted, analysed and published by the manufacturer, and in the version reviewed on 10 September 2026 the ethics-approval line read "[Ethics committee approval: to be confirmed.]". Naming the approving committee and reference, and completing external peer review, are the two steps that would move this record to a higher tier.

Editorial review

Reviewed by the Biohack Blueprint research team

Last verified

Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability