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

NCT04841499 | Completed DMC

• 1 other identifier: USAH-EH301
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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™

Conditions

Menopause

Keywords

pre menopause, peri menopause, post menopause, menopause, hot flashes, declining estradiol leves

Outcome Measures

Primary Outcomes (2)

• Production of Estradiol

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

  7 days

• Change undesirable effects of menopause

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

  7 days

Study Arms (1)

Treatment Arm

EXPERIMENTAL

7 days of BASIS™ orally

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

Interventions

BASIS™ (Crystalline Nicotinamide Riboside 250mg and Pterostilbene 50mg) DRUG

take 2 capsules orally each day for 7 days

Treatment Arm

Eligibility Criteria

• Age: 35 Years+
• Gender Eligibility Details: Biological female as determined at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Less than 35 years of age
• Hormone replacement therapy

Sponsors & Collaborators

• University of South Alabama: lead
• Elysium Health, Inc.: collaborator

Study Sites (1)

University of South Alabama

Mobile, Alabama, 36604, United States

Location

Related Publications (9)

• Parazzini F. Resveratrol, tryptophanum, glycine and vitamin E: a nutraceutical approach to sleep disturbance and irritability in peri- and post-menopause. Minerva Ginecol. 2015 Feb;67(1):1-5.

  PMID: 25660429 RESULT

• Uberti F, Morsanuto V, Aprile S, Ghirlanda S, Stoppa I, Cochis A, Grosa G, Rimondini L, Molinari C. Biological effects of combined resveratrol and vitamin D3 on ovarian tissue. J Ovarian Res. 2017 Sep 15;10(1):61. doi: 10.1186/s13048-017-0357-9.

  PMID: 28915830 RESULT

• Davinelli S, Scapagnini G, Marzatico F, Nobile V, Ferrara N, Corbi G. Influence of equol and resveratrol supplementation on health-related quality of life in menopausal women: A randomized, placebo-controlled study. Maturitas. 2017 Feb;96:77-83. doi: 10.1016/j.maturitas.2016.11.016. Epub 2016 Nov 27.

  PMID: 28041599 RESULT

• Leo L, Surico D, Deambrogio F, Scatuzzi A, Marzullo P, Tinelli R, Molinari C, Surico N. [Preliminary data on the effectiveness of resveratrol in a new formulation in treatment of hot flushes]. Minerva Ginecol. 2015 Oct;67(5):475-83. Italian.

  PMID: 26491826 RESULT

• Narumi M, Takahashi K, Yamatani H, Seino M, Yamanouchi K, Ohta T, Takahashi T, Kurachi H, Nagase S. Oxidative Stress in the Visceral Fat Is Elevated in Postmenopausal Women with Gynecologic Cancer. J Womens Health (Larchmt). 2018 Jan;27(1):99-106. doi: 10.1089/jwh.2016.6301. Epub 2017 Aug 17.

  PMID: 28816586 RESULT

• Murugesan K, Vij U, Lal B, Farooq A. Effect of progestins, estradiol, and coenzymes NAD and NADPH on the interconversion of estradiol and estrone in rabbit uterus in vitro. Steroids. 1989 Jun;53(6):695-712. doi: 10.1016/0039-128x(89)90061-5.

  PMID: 2554542 RESULT

• Yaku K, Okabe K, Nakagawa T. NAD metabolism: Implications in aging and longevity. Ageing Res Rev. 2018 Nov;47:1-17. doi: 10.1016/j.arr.2018.05.006. Epub 2018 Jun 5.

  PMID: 29883761 RESULT

• Bonkowski MS, Sinclair DA. Slowing ageing by design: the rise of NAD+ and sirtuin-activating compounds. Nat Rev Mol Cell Biol. 2016 Nov;17(11):679-690. doi: 10.1038/nrm.2016.93. Epub 2016 Aug 24.

  PMID: 27552971 RESULT

• Joffe H, Petrillo LF, Koukopoulos A, Viguera AC, Hirschberg A, Nonacs R, Somley B, Pasciullo E, White DP, Hall JE, Cohen LS. Increased estradiol and improved sleep, but not hot flashes, predict enhanced mood during the menopausal transition. J Clin Endocrinol Metab. 2011 Jul;96(7):E1044-54. doi: 10.1210/jc.2010-2503. Epub 2011 Apr 27.

  PMID: 21525161 RESULT

MeSH Terms

Conditions

Hot Flashes

Interventions

Pterocarpus marsupium

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: April 5, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)