Efficacy of a Dietary Supplement Powder Formula (Daily Ultimate Essentials) in an Adult Population.

October 22, 2024 updated by: Prenetics Global

A 12-week Randomized, Controlled, Clinical Trial Evaluating the Efficacy of a Dietary Supplement Powder Formula (Daily Ultimate Essentials) in an Adult Population.

Healthy Adult subjects

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 12 weeks. The subjects will attend two appointments in the clinic throughout the duration of the study.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

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
      • San Francisco, California, United States, 94127
        • San Francisco Research Institute

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI between 18.5 and 30 kg/m2
  • Low, moderate, and high activity (self-identified) *
  • Self-identify as having fatigue, and abdominal issues (bloating, constipation etc.) *
  • Participants will be able to read, understand and sign an informed consent form (includes HIPAA and States requirements) and sign a photo release form.
  • Participants are willing and able to follow all study directions, attend study visits as scheduled and must be willing to accept the restrictions of the study including but not limited to:
  • Willing to refrain from introducing any new diets or dietary supplements for the duration of the study

Exclusion Criteria:

-

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reds Powder
Dietary supplement: REDS Powder
Dietary supplement powder
No Intervention: Standard
Usual Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Morphology
Time Frame: 12 weeks
Subjects assessed through weight and height which will be combined to determine BMI and abdominal and thigh circumference and images before and after
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
12 weeks
Energy
Time Frame: 12 weeks
Assessed by subjective questionnaire
12 weeks
Changes in Micronutrient blood levels
Time Frame: 12 weeks
Assessed through laboratory assays of vitamins and minerals in the blood
12 weeks

Collaborators and Investigators

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

Sponsor

Prenetics Global

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)

October 1, 2024

Primary Completion (Estimated)

February 14, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR20240501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

deidentified data will be shared with data analysis team

IPD Sharing Time Frame

end of the trial - 2/2025 through end of analysis 5-25

IPD Sharing Access Criteria

Data team will access data through encrypted password protected central server and it will be all raw data and subject numbers and blinding code

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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