NCT06749808

A Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption

A Randomized, Double-Blind, Placebo Controlled, Single Center Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Pharmanex · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this placebo controlled randomized research is to demonstrate the health benefits of a carotenoid nutritional supplement as compared to placebo in terms of nutrient levels, quality of life, feelings, of wellness, brain health, energy, immunity, and appearance.

Detailed description

Female or male subjects will be enrolled in this single site study to evaluate the efficacy and tolerability of a nutritional supplement. Subjects who sign consent and meet all inclusion criteria and none of the exclusion criteria will be enrolled at the baseline visit. Vital signs will be obtained (height, weight, blood pressure, heart rate). Subjects must meet the study BMI requirements (≥18.5 and ≤29.9 kg/m2 ). Subjects will also complete BioPhotonic Scanner screening. If subjects meet all requirements, they will be randomized to receive either the active nutritional supplement or a placebo. Subjects will undergo phlebotomy for baseline lab work consisting of carotenoid analysis. Subjects will complete the following questionnaires/measurements: 1. Quality of Life Questionnaire 2. Diet and Lifestyle Questionnaire 3. Subject Skin Assessment 4. Biophotonic Scanner measurement 5. Mini-4 Scanner measurement The nutritional supplement will be started and the subjects will return to the research center at Weeks 4 and 8 for evaluation.

Conditions

• Nutrition Status

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Carotenoid Nutritional Supplement	Carotenoid Nutritional Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 10 mg Lutein, 2 mg Zeaxanthin, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc
DIETARY_SUPPLEMENT	Placebo	Placebo Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2024-12-27
• Last updated: 2024-12-31

Locations

1 site across 1 country: United States