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Clinical Trial Summary

The primary objective of this study is to understand if the test product (HUM supplement) reduces the number of hot flashes in Perimenopausal women and to see if it improves mood and other symptoms usually experienced with menopause. The secondary objective is to examine the effect on the quality of life, safety, and tolerability of daily use of HUM menopause supplementation taken daily by individuals with VMS.

Clinical Trial Description

This will be a 2-arm randomized, double-blinded, placebo-controlled study in which individuals with menopause symptoms, and in particular hot flashes and mood swings will receive either daily HUM menopause supplementation or a placebo as a control for a period of 8 weeks. It is hypothesized that the dietary supplement will improve subjective wellbeing in trial participants by reducing symptoms of menopause. A total of 110 participants will be recruited for the trial following screening (55 in each group), with the expectation that at least 100 participants will complete the trial (50 in each group). The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05037877
Study type Interventional
Source HUM Nutrition, Inc.
Contact Patrick Renner, MSc
Phone 4242450284
Email [email protected]
Status Recruiting
Phase N/A
Start date August 31, 2021
Completion date October 31, 2021

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