An Exploratory Investigation of Dietary Supplementation a... | NCT05037877

Studies
An Exploratory Investigation of Dietary Supplementation and Its Effect

NCT05037877

Sponsor

HUM Nutrition, Inc.

Status

Completed

Last Update Posted

Apr 8, 2022Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Quality of Life

Interventions

HUM supplement
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2021Actual

Primary Completion Date

Oct 31, 2021Actual

Completion Date

Oct 31, 2021Actual

First Submitted Date

Aug 31, 2021

First Submission Date that Met QC Criteria

Aug 31, 2021

First Posted Date

Sep 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2022

Last Update Posted Date

Apr 8, 2022Actual

Name	Class
Citruslabs	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Active Comparator	HUM supplement - 1 capsule per day	Dietary Supplement: HUM supplement
Placebo group	Placebo Comparator	Placebo supplement - 1 capsule per day	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HUM supplement	Dietary Supplement	HUM supplement - 1 capsule per day	Intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susanne Mitschke	Citruslabs	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Citruslabs		Santa Monica	California	90404	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided