Dietary Supplement for Nutrition

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Prenetics Global

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must refrain from starting any new diets or dietary supplements during the study.

Is REDS Powder safe for human use?

There are safety concerns with dietary supplements like REDS Powder, especially if it contains ingredients like red yeast rice, which has been linked to serious health issues such as kidney and liver failure. It's important to be cautious and consult with a healthcare provider before using such supplements. ^{1 2 3 4 5}

How does the REDS Powder treatment differ from other treatments for nutritional deficiencies?

REDS Powder is unique because it is a dietary supplement that aims to optimize nutrient levels by providing a broad spectrum of essential vitamins, minerals, and trace elements, which are balanced for synergies and metabolic functions. This approach is different from standard treatments that may not focus on such a comprehensive and balanced nutrient formulation. ^{6 7 8 9 10}

What is the purpose of this trial?

Healthy Adult subjects

Eligibility Criteria

This trial is for healthy adults with a BMI between 18.5 and 30, who feel tired often and have stomach issues like bloating or constipation. They should be active to some degree, able to follow the study's rules without starting new diets or supplements during the trial, and must understand and sign consent forms.

Inclusion Criteria

BMI between 18.5 and 30 kg/m2

Low, moderate, and high activity (self-identified)

Participants will be able to read, understand and sign an informed consent form (includes HIPAA and States requirements) and sign a photo release form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the dietary supplement powder formula for 12 weeks

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• REDS Powder

Trial Overview The trial is testing 'Daily Ultimate Essentials,' a dietary supplement powder known as REDS Powder. It aims to see if this supplement can improve general health in adults when taken regularly.

Participant Groups

Group I: Reds Powder Experimental Treatment 1 Intervention

Reds Powder

Group II: Standard Active Control 1 Intervention

Usual Diet

Who Is Running the Clinical Trial?

Prenetics Global

Lead Sponsor

Trials

2

Recruited

90+

Findings from Research

Over 70% of Americans use dietary supplements daily, yet these products are not required to be approved by the FDA before being sold, leading to potential safety concerns.

While many supplements are widely consumed, there is limited evidence supporting their health benefits in well-nourished adults, and some can cause significant toxicity or interact negatively with prescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. Ronis, MJJ., Pedersen, KB., Watt, J.[2020]

A total of 94 reports of adverse health events related to red yeast rice (RYR) supplements were analyzed, revealing 187 adverse drug reactions (ADRs), with the most common being musculoskeletal disorders (64 cases) and gastrointestinal issues (33 cases).

The study highlights significant safety concerns regarding RYR supplements, particularly due to the potential serious adverse effects from monacolin K, indicating a need for further research to fully understand their safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb. Vrolijk, MF., van de Koppel, S., van Hunsel, F.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Overview of FDA's Redbook guidelines. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. [2020]

3. Denmark pubmed.ncbi.nlm.nih.gov

[Red yeast rice as the presumed cause of acute kidney and liver failure]. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Food and Drug Administration proposed testing guidelines for developmental toxicity studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration. [2007]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Nutraceutical Formula Is Effective in Raising the Circulating Vitamin and Mineral Levels in Healthy Subjects: A Randomized Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Regulatory alerts for dietary supplements in Canada and the United States, 2005-13. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Progress in developing analytical and label-based dietary supplement databases at the NIH Office of Dietary Supplements. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[Doping and dietary supplements]. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Dietary Supplement Ingredient Database (DSID) and the Application of Analytically Based Estimates of Ingredient Amount to Intake Calculations. [2023]