Comparison of Two Qualia NAD⁺ Formulations on Intracellular NAD⁺ Levels

Официальное название

Comparison of Two Qualia NAD⁺ Formulations on Intracellular NAD⁺ Levels: A Randomized, Double-Blind, Placebo-Controlled Three-Arm Trial

Обзор

This is a randomized, double-blind, placebo-controlled, parallel-group study evaluating the effects of two distinct Qualia NAD⁺ formulations on intracellular NAD⁺ levels in healthy adults aged 35-75 years. Approximately 180 participants will be randomized to one of three study arms: Qualia NAD⁺ version 1, Qualia NAD⁺ version 2, or placebo. Each participant will take two capsules of their assigned product once daily in the morning, with or without food, over a 28-day period. The primary outcome is the change in intracellular NAD⁺ levels, assessed via at-home finger-stick blood collection at baseline and study completion. Secondary endpoints include changes in aging-related symptoms (AMFS scores), health-related quality of life (RAND SF-36), and evaluation of safety and tolerability. All assessments, including electronic questionnaires, are completed remotely without in-person visits.

Вмешательства

• Пищевая добавка Qualia NAD⁺ version 1
  Qualia NAD+ version 1 manufactured by Qualia Life Sciences
• Пищевая добавка Qualia NAD⁺ version 2
  Qualia NAD+ version 2 manufactured by Qualia Life Sciences
• Пищевая добавка Placebo
  Rice Flour

Первичные конечные точки

• Between-group change in intracellular NAD⁺ levels [Срок оценки: 28 days]

Вторичные конечные точки (4)

• Aging-Related Symptoms (AMFS scores) [Срок оценки: 4 weeks]
• RAND SF-36 Scale Scores [Срок оценки: 4 weeks]
• Side effect profile as measured by a custom Safety and Tolerability survey [Срок оценки: Week 1, 2, 3, and 4]
• Within-group differences in the change in intracellular NAD⁺ levels [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

Provide voluntary, written, informed consent to participate in the study Agree to provide a valid cell phone number and are willing to receive communications through text Can read and write English Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly Willing to complete questionnaires, records, and diaries associated with the study.

Healthy male and female participants aged 35-75 years Willing to self-administer the intracellular NAD⁺ finger-stick test at home (baseline and Day 28) Willing to avoid supplements, energy drinks/shots, or other products containing niacin, niacinamide, nicotinamide riboside, or NMN for ≥ 2 weeks before baseline and throughout the study

Критерии исключения

Women who are pregnant, breastfeeding, or planning to become pregnant during the trial Known food intolerances/allergy to any ingredients in the product Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer Having had a significant cardiovascular event in the past 6 months Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines On immunosuppressive therapy Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Qualia Life Sciences — Carlsbad

Идентификаторы

NCT: NCT07132801 · QLS-014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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