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
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
- 是
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
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
