NCT06343610

The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose

The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose: Randomised Double Blind, Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: VIST - Faculty of Applied Sciences · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomized, placebo-controlled interventional study of the effect of multiple-dose dietary intake on minimal erythema dose and other skin parameters.

Detailed description

This is a double-blind, randomized, placebo-controlled interventional study of the effect of multiple-dose dietary intake on minimal erythema dose and other skin parameters. The study will be performed on 54 adults, between the ages 21 and 65 years and will include daily dietary supplementation over 8-weeks period. Participants will be randomly assigned in one of two groups, 27 in each. One group (test group) will receive investigational product, a syrup containing red orange extract, Calaguala extract and vitamins A, C, D, E and the other placebo syrup. Participants will continuously receive placebo or investigational product for 8 weeks in order to determine multiple-dose effects.

Conditions

• Minimal Erythema Dose

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active product	Contains a complex of: Calaguala leaves extract (Polypodium leucotomos), vitamin C (L-ascorbic acid), blood orange fruit extract (Citrus sinensis; red orange extract), vitamin E (alpha-tocopheryl acetate), vitamin A (retinyl palmitate), vitamin D3 cholecalciferol.
DIETARY_SUPPLEMENT	Placebo	No active ingredients.

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-06-14
• Completion: 2024-09-10
• First posted: 2024-04-02
• Last updated: 2025-02-11

Locations

1 site across 1 country: Slovenia