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

Phase 4
Active, not recruiting
Conditions
Dietary Assessment
Registration Number
NCT06655597
Lead Sponsor
Prenetics Global
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Body Morphology12 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 Outcome Measures
NameTimeMethod
Safety and Tolerability12 weeks

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

Energy12 weeks

Assessed by subjective questionnaire

Changes in Micronutrient blood levels12 weeks

Assessed through laboratory assays of vitamins and minerals in the blood

Trial Locations

Locations (1)

San Francisco Research Institute

🇺🇸

San Francisco, California, United States

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