An Exploratory Investigation of Dietary Supplementation and Its Effect

Not Applicable

Completed

• Conditions: Quality of Life
• Interventions: Dietary Supplement: HUM supplement; Dietary Supplement: Placebo

• Registration Number: NCT05037877
• Lead Sponsor: HUM Nutrition, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2021-08-31
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-08
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	HUM supplement	HUM supplement - 1 capsule per day
Placebo group	Placebo	Placebo supplement - 1 capsule per day

Primary Outcome Measures

Name	Time	Method
Quality of life improvements [Time Frame: Baseline to 8 weeks)	8 week	Survey-based assessment (0-5 scale) with higher scores representing an improved outcome

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States