NCT05037877

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

August 31, 2021

Last Update Submit

March 30, 2022

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

HUM supplementDIETARY_SUPPLEMENT

HUM supplement - 1 capsule per day

Intervention group
PlaceboDIETARY_SUPPLEMENT

Placebo supplement - 1 capsule per day

Placebo group

Eligibility Criteria

Age38 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Officials

  • Susanne Mitschke

    Citruslabs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This will be a 2-arm randomized, double-blinded, placebo-controlled study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

August 31, 2021

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)