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OpenTrials
Active, Not Recruiting

NCT Number: NCT06655597

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

Healthy Adult subjects

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Francisco Research Institute

San Francisco, California, 94127, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

REDS Powder

Dietary Supplement

Dietary supplement powder

Primary outcomes

  1. 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

Secondary outcomes

  1. Safety and Tolerability

    Time frame: 12 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Energy

    Time frame: 12 weeks

    Assessed by subjective questionnaire

  3. Changes in Micronutrient blood levels

    Time frame: 12 weeks

    Assessed through laboratory assays of vitamins and minerals in the blood

Sponsors and collaborators

Lead sponsor

Prenetics Global

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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