An Exploratory Investigation of Dietary Supplementation and Its Effect

March 30, 2022 updated by: HUM Nutrition, Inc.
The primary objective of this study is to understand if the test product (HUM supplement) improve symptoms experienced.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HUM Nutrition, Inc.

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2021

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20220HUM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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