Efficacy of a Dietary Supplement Powder Formula (Daily Ul... | NCT06655597

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

NCT06655597

Sponsor

Prenetics Global

Status

Active, not recruiting

Last Update Posted

Oct 23, 2024Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Dietary Assessment

Interventions

REDS Powder

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Feb 14, 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Oct 19, 2024

First Submission Date that Met QC Criteria

Oct 22, 2024

First Posted Date

Oct 23, 2024Actual

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

Oct 22, 2024

Last Update Posted Date

Oct 23, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Healthy Adult subjects

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.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reds Powder	Experimental	Reds Powder	Dietary Supplement: REDS Powder
Standard	No Intervention	Usual Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
REDS Powder	Dietary Supplement	Dietary supplement powder	Reds Powder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Morphology	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 Outcomes

Measure	Description	Time Frame
Safety and Tolerability	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	12 weeks
Energy	Assessed by subjective questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco Research Institute		San Francisco	California	94127	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

deidentified data will be shared with data analysis team

Types

Statistical Analysis Plan (SAP)
Analytic Code

Time Frame

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

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

URL

Not provided