Effects of a Seven-day BASIS™ Supplementation on Menopausal Syndromes and Measurements of the Urinary Vitamin B3 and Estradiol Levels in Pre-, Peri- and Post-menopause

Plain-language guide to NCT04841499: not phased interventional trial of NAD+, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04841499
Phase: not phased
Status: completed
Start: 2021-04-05
Completion (planned or actual): 2021-07-15
Participants: 40 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Menopause
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around NAD+.

It had 1 arm (groups): Treatment Arm (experimental).

7 days of BASIS™ orally.

The registry classes the interventions as drug.

More on the Plan

Protocol Outline Protocol Title: Effects of a seven-day BASIS™ supplementation on menopausal syndromes and measurements of the urinary vitamin B3 and estradiol levels in pre-, peri- and post-menopause.

Abstract Context: Nicotinamide adenine dinucleotide (NAD) is a derivative of vitamin B3 necessary to the production of key hormonal regulators like estradiol.

The other component of BASIS™ is pterostilbene, a phytoestrogen, derivative of resveratrol.

Phytoestrogens associate with the protection of estradiol levels and relief of menopausal syndrome in women using over-the-counter phytoestrogens.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to women only aged from 35 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 35 years of age or older. Pre, peri or post menopausal.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: less than 35 years of age; hormone replacement therapy.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label NAD+ study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-04-05 with completion listed for 2021-07-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Production of Estradiol (time frame: 7 days). Change undesirable effects of menopause (time frame: 7 days).

What This Means in Plain Language

Put simply, this is a not phased trial of NAD+ in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

NAD+ in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.