The Safety and Efficacy of an Oral Superfruits Supplement

The Safety and Efficacy of an Oral Superfruits Supplement for Skin Brightening and Wrinkle Reduction

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Other: Oral superfruits supplement

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Petaling Jaya, Selangor, Malaysia, 47810
      • Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral superfruits supplement; Participants will consume oral superfruits supplement once daily for 6 weeks.	Other: Other: Oral superfruits supplement; The supplement contain superfruits that are beneficial for human health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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)	Week 12

Collaborators and Investigators

• Sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: UMRAMREC003-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No