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An Exploratory Investigation of Dietary Supplementation and Its Effect

Sponsor
HUM Nutrition, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05037877
Collaborator
Citruslabs (Industry)
110
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
54.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: HUM supplement
  • Dietary Supplement: Placebo
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This will be a 2-arm randomized, double-blinded, placebo-controlled studyThis will be a 2-arm randomized, double-blinded, placebo-controlled study
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
An Exploratory Investigation of Dietary Supplementation and Its Effect
Actual Study Start Date :
Aug 31, 2021
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention group

HUM supplement - 1 capsule per day

Dietary Supplement: HUM supplement
HUM supplement - 1 capsule per day
Placebo Comparator: Placebo group

Placebo supplement - 1 capsule per day

Dietary Supplement: Placebo
Placebo supplement - 1 capsule per day

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
38 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Citruslabs Santa Monica California United States 90404

Sponsors and Collaborators

  • HUM Nutrition, Inc.
  • Citruslabs

Investigators

  • Principal Investigator: Susanne Mitschke, Citruslabs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HUM Nutrition, Inc.
ClinicalTrials.gov Identifier:
NCT05037877
Other Study ID Numbers:
  • 20220HUM
First Posted:
Sep 8, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 8, 2022