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DoNotAge Clinical Trial 1: What the 60-Day Finished-Formula Study Found

DoNotAge Trial 1 reports large 60-day improvements in WHO-5 well-being and FACIT-Fatigue versus placebo in 28 completers. The finished formula was tested, but ethics approval remains listed as “to be confirmed.”

By Dr. Khaled Mahmoud, MBBChPublished Last verified 4 min read
DoNotAge 15-in-1randomized controlled trialwell-beingfatiguefinished-formulation evidence
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Primary source for this analysis Open the original source ↗
Evidence contextThis page covers a company-hosted study report. Study design, measurement and company involvement are described separately from independent peer-reviewed evidence.

DoNotAge Clinical Trial 1 is the company’s strongest posted evidence for how people felt while taking the finished 15-ingredient DoNotAge® daily formulation. Unlike an article that borrows studies from individual ingredients, this 60-day study tested the combined sachet against a matched placebo in a randomized, double-blind design.

The company-posted results are substantial: well-being improved markedly, fatigue scores improved beyond the stated minimally clinically important difference, and every treatment-group completer met the report’s responder threshold on both primary endpoints. The evidence is promising for the finished formula—but the small sample, per-protocol analysis, company-hosted reporting and still-unresolved ethics-approval line materially affect how strongly the study should be interpreted.

DoNotAge Clinical Trial 1 at a glance

Study feature Reported detail
Design Randomized, double-blind, placebo-controlled, parallel-group trial
Duration 60 days
Location Single clinical site in Dubai, UAE
Enrolled 30 generally healthy adults aged 30–65
Completed 28: 15 DoNotAge®, 13 placebo
Intervention One daily sachet of the complete DoNotAge® multi-ingredient formulation
Primary outcomes WHO-5 Well-Being Index and FACIT-Fatigue
Secondary outcomes GI tolerability, willingness to continue and global impression of change
Analysis Per-protocol analysis of completers
Evidence status Company-hosted randomized trial report; no peer-reviewed journal publication identified as of October 10, 2026

What did the 60-day trial find?

Outcome DoNotAge® Placebo Reported between-group result
WHO-5 well-being 34.4 → 70.4; change +36.0 33.8 → 43.7; change +9.8 Difference in change +26.2; p<0.0001
FACIT-Fatigue 26.0 → 30.9; change +4.9 26.0 → 25.9; change −0.1 Difference in change +4.9; p<0.0001
WHO-5 responders 15/15 2/13 Responder threshold: ≥10-point increase
FACIT-Fatigue responders 15/15 0/13 Responder threshold: ≥4-point increase

The report states that the treatment group’s WHO-5 improvement exceeded the 10-point minimally clinically important difference used in the study. FACIT-Fatigue improved by 4.9 points, also exceeding the report’s 3–4 point clinically important range. Higher FACIT-Fatigue scores indicate less fatigue.

DoNotAge’s report calculates a Cohen’s d of 2.87 for the WHO-5 change and 15.47 for FACIT-Fatigue. Those are exceptionally large standardized effects. They are the company report’s calculations and should be read in the context of a very small completer sample rather than assumed to represent the effect size a larger independent replication would necessarily reproduce.

What about gastrointestinal tolerability?

The study used the Gastrointestinal Symptom Rating Scale as a secondary tolerability measure. The posted report says there were no clinically meaningful changes across the GSRS domains during the 60 days and characterizes the formulation as well tolerated from a gastrointestinal perspective.

At the endpoint, the report also says 100% of treatment participants answered that they would “probably” or “definitely” continue taking the formulation, while 93% rated their health as somewhat or much better. These are useful acceptability signals, but they remain participant-reported outcomes within the same blinded 60-day study.

Why this study is more relevant than ingredient-only evidence

The central strength of Trial 1 is product relevance. The intervention was the finished DoNotAge® daily sachet—not NMN alone, resveratrol alone, quercetin alone or another ingredient studied somewhere else.

That means the trial can inform claims about the combined formulation more directly than a stack of unrelated ingredient papers can. It also means the result cannot tell us which ingredient, interaction or combination produced the reported effect. The intervention is the formula as a whole.

What are the main strengths?

  • Randomization: participants were allocated to treatment or placebo.
  • Double blinding: the report describes both participants and investigators as blinded.
  • Matched placebo: the comparison was not simply before-versus-after use.
  • Finished-product testing: the actual multi-ingredient formulation was tested.
  • Predefined validated questionnaires: WHO-5 and FACIT-Fatigue were used as the primary outcomes.
  • Clinically interpretable thresholds: the report compared changes with minimally clinically important differences, not only p-values.

What limits the evidence?

1. Only 28 participants completed the trial

Thirty people were enrolled, but the primary analysis was conducted on the 28 completers. That is a small trial, so estimates are inherently less stable than they would be in a larger confirmatory study.

2. Both withdrawals were in the placebo group

Two placebo participants withdrew before Day 60. The report uses a per-protocol completer analysis rather than an intention-to-treat analysis of all randomized participants. That does not make the findings invalid, but it is an important feature of the analysis.

3. The primary outcomes were subjective

WHO-5 and FACIT-Fatigue are established patient-reported measures, but they measure how participants report feeling. Trial 1 did not establish an objective biomarker change, biological-age reversal or lifespan effect.

4. It is a company-hosted report

The full study report is published on a DoNotAge-owned website. No peer-reviewed journal publication for Trial 1 has been identified as of October 10, 2026. Independent peer review, larger replication and transparent external oversight would strengthen confidence in the magnitude and generalizability of the reported effects.

5. The ethics-approval line remains unresolved

The methods section currently states that informed consent was obtained and that the protocol was designed in accordance with the Declaration of Helsinki. It also literally contains the bracketed statement “Ethics committee approval: to be confirmed.”

Until the report is updated with a named approving committee and approval reference—or another primary source supplies that information—the ethics-approval documentation remains incomplete.

What can we reasonably conclude?

The most supportable conclusion is that DoNotAge has posted a small randomized, double-blind, placebo-controlled finished-formulation study reporting large improvements in self-reported well-being and fatigue over 60 days compared with placebo, with no meaningful GI deterioration reported.

That is materially stronger evidence for the finished formula than simply citing studies on its ingredients. It is not yet the same evidentiary position as a larger independently replicated, peer-reviewed clinical trial with fully documented ethics oversight.

What should happen next?

  • a larger preregistered confirmatory trial;
  • independent or multicentre replication;
  • intention-to-treat analysis alongside per-protocol analysis;
  • complete ethics-committee documentation;
  • peer-reviewed publication with full methods and adverse-event reporting; and
  • objective endpoints alongside patient-reported outcomes where appropriate.

Primary source

DoNotAge Clinical Trial 1 FAQ

Was Trial 1 randomized and placebo controlled?

Yes. The company report describes a randomized, double-blind, placebo-controlled parallel-group design.

How many people completed the study?

Twenty-eight participants completed it: 15 in the DoNotAge group and 13 in the placebo group.

Did well-being improve?

The report says WHO-5 scores increased by 36.0 points in the treatment group versus 9.8 points in placebo, producing a reported difference in change of 26.2 points with p<0.0001.

Did fatigue improve?

The report says FACIT-Fatigue improved by 4.9 points in the treatment group versus −0.1 in placebo. Higher FACIT-Fatigue scores indicate less fatigue.

Was the finished product tested?

Yes. The report describes testing the complete DoNotAge® multi-ingredient sachet against a matched placebo.

Has the study been peer reviewed?

No peer-reviewed journal publication has been identified as of October 10, 2026.

Was ethics approval confirmed?

The posted report says informed consent was obtained but still contains the statement “Ethics committee approval: to be confirmed.” The ethics-approval documentation therefore remains unresolved.

Linked entities and research

Research projectCompany-hosted report; independent peer-reviewed publication not verified

DoNotAge Finished-Formulation Trial 1 — Well-Being, Fatigue and GI Tolerability

The finished DoNotAge daily formulation was tested, and the report is authored/hosted by the DoNotAge.org Research Team on a DoNotAge-owned site.

Project source ↗