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An Exploratory Investigation of Dietary Supplementation and Its Effect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05037877
Recruitment Status : Completed
First Posted : September 8, 2021
Last Update Posted : April 8, 2022
Sponsor:
Collaborator:
Citruslabs
Information provided by (Responsible Party):
HUM Nutrition, Inc.

Study Description
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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
Quality of Life Dietary Supplement: HUM supplement Dietary Supplement: Placebo Not Applicable

Detailed Description:
This will be a 2-arm randomized, double-blinded, placebo-controlled study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This 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 : August 31, 2021
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   38 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037877


Locations
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United States, California
Citruslabs
Santa Monica, California, United States, 90404
Sponsors and Collaborators
HUM Nutrition, Inc.
Citruslabs
Investigators
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Principal Investigator: Susanne Mitschke Citruslabs
More Information
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Responsible Party: HUM Nutrition, Inc.
ClinicalTrials.gov Identifier: NCT05037877    
Other Study ID Numbers: 20220HUM
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No