The Safety and Efficacy of an Oral Superfruits Supplement

NCT05694182 | Completed

• 1 other identifier: UMRAMREC003-22
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.The skin brightening effect of the oral superfruits supplement.
2. 2.The effect of the oral superfruits supplement on wrinkle reduction.
3. 3.To observe any adverse effect occurrence with the consumption of the oral superfruits supplement.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Oral superfruits supplement

EXPERIMENTAL

Participants will consume oral superfruits supplement once daily for 6 weeks.

Other: Other: Oral superfruits supplement

Interventions

Other: Oral superfruits supplement OTHER

The supplement contain superfruits that are beneficial for human health

Oral superfruits supplement

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Malaysian citizen
• Male and female (age 20-60 years old)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Petaling Jaya, Selangor, 47810, Malaysia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: December 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 1, 2023
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)