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NCT05037877 Clinical Trial

An Exploratory Investigation of Dietary Supplementation and Its Effect

Quality of Life Clinical Trial

Official title:
An Exploratory Investigation of Dietary Supplementation and Its Effect

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05037877
Other study ID # 20220HUM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2021
Est. completion date October 31, 2021

Study information
Verified date March 2022
Source HUM Nutrition, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to understand if the test product (HUM supplement) improve symptoms experienced.

Description:

This will be a 2-arm randomized, double-blinded, placebo-controlled study.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 38 Years to 60 Years
Eligibility Inclusion Criteria: - Female - Willing to maintain the current dietary pattern, activity level, and stable body weight for the duration of the study - Must be in good health (don't report any medical conditions asked in the screening questionnaire) - Willing and able to provide written informed consent Exclusion Criteria: - Allergies to any test product ingredients - Any other severe chronic disease - Pregnant, want to become pregnant for the duration of the study, or who are breastfeeding - Participating in an investigational health product research study

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• HUM supplement
HUM supplement - 1 capsule per day
• Placebo
Placebo supplement - 1 capsule per day

Locations
Country Name City State
United States Citruslabs Santa Monica California

Sponsors (2)
Lead Sponsor Collaborator
HUM Nutrition, Inc. Citruslabs

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life improvements [Time Frame: Baseline to 8 weeks) Survey-based assessment (0-5 scale) with higher scores representing an improved outcome 8 week
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