The Safety and Efficacy of an Oral Superfruits Supplement

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre15 enrolled

Overview

This study is conducted to evaluate the safety and effectiveness of an oral superfruits supplement for skin brightening and wrinkle reduction. Superfruits are reported to have high bioactive compounds with beneficial effects on human health. The study duration is 12 weeks and the skin assessment will be carried out at baseline, week 2, week 6 and week 12. The participants will consume the supplement for 6 weeks and at week 12, final skin assessment will be conducted. The main questions this study aims to answer are: 1. The skin brightening effect of the oral superfruits supplement. 2. The effect of the oral superfruits supplement on wrinkle reduction. 3. To observe any adverse effect occurrence with the consumption of the oral superfruits supplement.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Malaysian citizen * Male and female (age 20-60 years old) Exclusion Criteria: * Participant who taking any dietary supplements for the past 4 weeks which can affect the study results * Participant who are on contraceptive pills for the past 3 months * Participant who undergo cosmetics treatments such as botox, filler and laser and light treatment within the last 3 months * Pregnant or plans to get pregnant and breastfeeding women

Outcomes

Primary Outcomes

Changes in skin tone from baseline and at week 2, week 6 and week 12 after consumption of the superfruits supplement

Skin tone will be assessed using JANUS III skin analyzer

Time frame: Baseline, week 2, week 6 and week 12

Changes in skin wrinkles from baseline and at week 2, week 6 and week 12 after consumption of the superfruits supplement

Skin wrinkles will be assessed using JANUS III skin analyzer and Wrinkle Severity Rating Scale (WSRS). For WSRS, dermatologists will evaluate participants' wrinkles based on 5-point photonumeric rating scale that will objectively evaluate the severity of crow's feet at rest (static) and with a smiling expression (dynamic). The scale scores are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.

Time frame: Baseline, week 2, week 6 and week 12

Adverse effect after consumption of the superfruits supplement

Based on adverse effect occurrence on participants that occur during study period (12 weeks)

Time frame: Week 12