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

NCT06655597 | Active Not Recruiting Phase 4

• 1 other identifier: PR20240501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy Adult subjects

Conditions

Dietary Assessment

Keywords

Dietary Supplement; Healthy Adults

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Safety and Tolerability

  12 weeks

• Energy

  12 weeks

• Changes in Micronutrient blood levels

  12 weeks

Study Arms (2)

Reds Powder

EXPERIMENTAL

Reds Powder

Dietary Supplement: REDS Powder

Standard

NO INTERVENTION

Usual Diet

Interventions

REDS Powder DIETARY_SUPPLEMENT

Dietary supplement powder

Reds Powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Prenetics Global: lead

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94127, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 23, 2024
• Study Start: October 1, 2024
• Primary Completion: February 14, 2025
• Study Completion: June 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

US (1)