Effects of Opuntia Ficus-indica Supplementation on Antioxidant Status and Inflammation Levels

NCT06657963 | Completed

• 1 other identifier: LTA001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if supplementation Opuntia ficus-indica improve the antioxidant status and inflammation levels of the participants. The main questions it aims to answer are:

1. 1.Does supplementation Opuntia ficus-indica improve the antioxidant status of the participants?
2. 2.Does supplementation Opuntia ficus-indica improve the inflammation levels of the participants?

Conditions

Antioxidant Capabilities; Inflammation Biomarkers

Keywords

Antioxidant capabilities; Inflammation levels; Opuntia ficus-indica; Oral supplementation; Reactive Oxygen Species (ROS)

Outcome Measures

Primary Outcomes (2)

• Antioxidant Status

  Unstimulated saliva samples were collected using a sterile 2.0-mL vial. Participants uncapped the vial, placed the straw into the vial, and passively drooled down the straw for 90 secs. All samples were assayed for different parameters in duplicates. Total antioxidant capacity was assayed using Elabsciecne total T-AOC colourimetric assay kit (Elabscience Biotechnology Co. Ltd, Texas, United States), MDA as lipid peroxidation biomarker was assayed using Elabsciecne MDA colourimetric assay Kit (Elabscience Biotechnology Co. Ltd, Texas, United States), 3-NT as a biomarker of oxidative stress-derived protein damage was assayed using Elabsciecne 3-NT ELISA Kit (Elabscience Biotechnology Co. Ltd, Texas, United States) and 8-OHdG as a biomarker of oxidative stress-derived DNA damage was assayed using Elabsciecne 8-OHdG ELISA Kit (Elabscience Biotechnology Co. Ltd, Texas, United States).

  From enrollment to the end of intervention at 12 weeks

• Inflammation Levels

  Unstimulated saliva samples were collected using a sterile 2.0-mL vial. Participants uncapped the vial, placed the straw into the vial, and passively drooled down the straw for 90 secs. All samples were assayed for different parameters in duplicates. Inflammatory markers IL-1beta, IL-6 and IL-10 were assayed using Elabsciecne ELISA Kit (Elabscience Biotechnology Co. Ltd, Texas, United States).

  From enrollment to the end of intervention at 12 weeks

Secondary Outcomes (4)

• Vital Signs - Blood Pressure

  From enrollment to the end of intervention at 12 weeks

• Vital Signs - Heart Rate

  From enrollment to the end of intervention at 12 weeks

• Vital Signs - Body Temperature

  From enrollment to the end of intervention at 12 weeks

• General Wellbeing

  From enrollment to the end of intervention at 12 weeks

Study Arms (1)

Interventional Arm

EXPERIMENTAL

Dietary Supplement: Opuntia ficus-indica Supplementation

Interventions

Opuntia ficus-indica Supplementation DIETARY_SUPPLEMENT

Participants are required to consume oral supplementation of OFi fine powder packaged in individual sachets (LifeGreenTM, LifeTree Asia, Selangor, Malaysia) at the dosage of 1500 mg once daily for 3 months.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• generally healthy individually
• aged 18 years and above
• capable of understanding the study protocol and information
• willing to provide informed consent.

You may not qualify if:

• currently undergoing supplementation aimed at enhancing antioxidant status
• having undergone major surgical procedures within six months before study entry
• pregnant or lactating woman.

Sponsors & Collaborators

• LifeTree Asia Sdn Bhd: lead

Study Sites (1)

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (1)

• Martemucci G, Portincasa P, Di Ciaula A, Mariano M, Centonze V, D'Alessandro AG. Oxidative stress, aging, antioxidant supplementation and their impact on human health: An overview. Mech Ageing Dev. 2022 Sep;206:111707. doi: 10.1016/j.mad.2022.111707. Epub 2022 Jul 14.

  PMID: 35839856 BACKGROUND

Study Design

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

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available immediately following publication with no end date.
• Access Criteria: Data will be shared with anyone who wishes to access with reasonable request.

Locations

MY (1)