The Safety and Efficacy of an Oral Superfruits Supplement

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05694182
• Other study ID #: UMRAMREC003-22
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 1, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Other: Oral superfruits supplement
The supplement contain superfruits that are beneficial for human health

Locations

Country	Name	City	State
Malaysia	Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre	Petaling Jaya	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Adverse effect after consumption of the superfruits supplement	Based on adverse effect occurrence on participants that occur during study period (12 weeks)	Week 12