Dietary AssessmentPhase 4NCT06655597
Efficacy of a Dietary Supplement Powder Formula (Daily Ultimate Essentials) in an Adult Population.
A Phase 4 study testing REDS Powder in people with Dietary Assessment, run by Prenetics Global at 1 site in United States.
Trial summary
Healthy Adult subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Assessment
- What is being tested?
- REDS Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Research Institute
San Francisco, California, 94127
About this study
Official title: 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
Read the 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.
- Conditions
- Dietary Assessment
- Being tested
- REDS Powder
- Keywords
- Dietary Supplement, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REDS PowderDietary supplement
Dietary supplement powder
| Study group | Role | What they receive |
|---|---|---|
| Reds Powder | Experimental | Reds Powder Receives: Dietary Supplement: REDS Powder |
| Standard | No intervention | Usual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (3)
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 weeks
Energy
Assessed by subjective questionnaire
Measured: 12 weeks
Changes in Micronutrient blood levels
Assessed through laboratory assays of vitamins and minerals in the blood
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Oct 2024
- Primary completion14 Feb 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prenetics Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655597
- Sponsor's protocol ID
- PR20240501
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified data will be shared with data analysis team
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Controlled, Clinical Trial Evaluating the Efficacy of a Dietary Supplement Powder Formula (Daily Ultimate Essentials) in an Adult Population.
- ClinicalTrials.gov ID
- NCT06655597
- Acronym / sponsor ID
- PR20240501
- Conditions
- Dietary Assessment
- Keywords
- Dietary Supplement, Healthy Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prenetics GlobalIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reds Powder | Experimental | Dietary Supplement: REDS PowderReds Powder |
| Standard | No intervention | –Usual Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REDS PowderDietary supplement powder | Dietary supplement | Reds Powder |
Primary outcome
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
3 secondary outcomes
Safety and Tolerability
Time frame: 12 weeks
Energy
Time frame: 12 weeks
Changes in Micronutrient blood levels
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Yes. deidentified data will be shared with data analysis team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing REDS Powder in people with Dietary Assessment, run by Prenetics Global at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Morphology (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.