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临床试验/NCT04841499
NCT04841499已完成不适用

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

University of South Alabama1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Production of Estradiol

研究概览

简要总结

The purpose of this study is to determine whether a short supplementation (7days) with BASIS™ increases the natural production of estradiol, measured in urinary waste. The overall objective is to determine whether through increased estradiol levels, the undesirable menopausal effects, assessed via questionnaires, are mitigated by a short-term supplementation with BASIS™

详细描述

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.

I. Abstract

Context:

Nicotinamide adenine dinucleotide (NAD) is a derivative of vitamin B3 necessary to the production of key hormonal regulators like estradiol. As we age, both NAD levels and estradiol levels are reduced. Reduced estradiol levels have been associated with menopausal syndromes. BASIS™ recent clinical outcomes have shown that this NAD precursor (BASIS™) boosts declining NAD levels. In an n=1 study, repeated over 3 years, a short intake (<1week at 125mg/day) of over-the-counter nicotinamide riboside, one of the two active ingredients of BASIS™, by a peri-menopausal 50-year-old female, resulted in the blunting of the undesirable menopausal effects such as poor sleep and hot flashes. 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. These outcomes and observations have prompted the proposed study. We wish to establish whether the observed beneficial effects of nicotinamide riboside and the reported beneficial effects of phytoestrogens on menopausal syndromes can work synergistically with a product like BASIS™ and are observed more broadly in peri- and menopausal women. Furthermore, we wish to establish whether remediation of symptoms can be attributed to a naturally occurring increase in estradiol levels following the repletion of NAD by BASIS™.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 35 years of age or older
  • pre, peri or post menopausal

排除标准

  • Less than 35 years of age
  • Hormone replacement therapy

研究组 & 干预措施

Treatment Arm

Experimental

7 days of BASIS™ orally

干预措施: BASIS™ (Crystalline Nicotinamide Riboside 250mg and Pterostilbene 50mg) (Drug)

结局指标

主要结局

Production of Estradiol

时间窗: 7 days

To determine whether a short supplementation with BASIS™ impacts the natural production of estradiol, measured in urinary waste.

Change undesirable effects of menopause

时间窗: 7 days

To determine whether, through increased estradiol levels, the undesirable menopausal effects are impacted by a short-term supplementation with BASIS™.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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