An Exploratory Investigation of Dietary Supplementation and Its Effect

NCT ID: NCT05037877

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2021-10-31

Brief Summary

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

Detailed Description

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

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a 2-arm randomized, double-blinded, placebo-controlled study
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

HUM supplement - 1 capsule per day

Group Type ACTIVE_COMPARATOR

HUM supplement

Intervention Type DIETARY_SUPPLEMENT

HUM supplement - 1 capsule per day

Placebo group

Placebo supplement - 1 capsule per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement - 1 capsule per day

Interventions

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HUM supplement

HUM supplement - 1 capsule per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo supplement - 1 capsule per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

38 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

HUM Nutrition, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanne Mitschke

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20220HUM

Identifier Type: -

Identifier Source: org_study_id

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