Antioxidant CapabilitiesNCT06657963
Effects of Opuntia Ficus-indica Supplementation on Antioxidant Status and Inflammation Levels
A study testing Opuntia ficus-indica Supplementation in people with Antioxidant Capabilities and Inflammation Biomarkers, run by LifeTree Asia Sdn Bhd at 1 site in Malaysia.
Trial 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. Does supplementation Opuntia ficus-indica improve the antioxidant status of the participants? 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antioxidant Capabilities, Inflammation Biomarkers
- What is being tested?
- Opuntia ficus-indica Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally healthy individually
- aged 18 years and above
- capable of understanding the study protocol and information
- willing to provide informed consent.
Who cannot join
- currently undergoing supplementation aimed at enhancing antioxidant status
- having undergone major surgical procedures within six months before study entry
- pregnant or lactating woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Opuntia Ficus-indica Supplementation on Improving Antioxidant and Inflammation Levels
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:
- Does supplementation Opuntia ficus-indica improve the antioxidant status of the participants?
- Does supplementation Opuntia ficus-indica improve the inflammation levels of the participants?
Read more
Researchers will compare before and after intervention to see if supplementation Opuntia ficus-indica works to improve the antioxidant status and inflammation levels of the participants.
Participants will:
Take drug supplementation Opuntia ficus-indica every day for 12 weeks. Visit the clinic once every 4 weeks for checkups and tests
Read the detailed description
Study Design
This open-label, single-arm, prospective study involved a supplementation period of three months. The research was conducted in full compliance with the Declaration of Helsinki and the criteria outlined in Malaysian guidelines for Good Clinical Practice [76]. Participant eligibility was confirmed according to the protocol checklist, and written informed consent was obtained from all participants. The study received approval from the Institutional Ethics Committee, UCSI University, Malaysia, approval code is IEC-2022-FMHS-082.
Participants Selection
Participants were recruited through off-campus advertisements, and the study was conducted at UCSI University in Kuala Lumpur, Malaysia. The inclusion criteria were as follows: (1) generally healthy individually; (2) aged 18 years and above; (3) capable of understanding the study protocol and information; and (4) willing to provide informed consent. Exclusion criteria included: (1) currently undergoing supplementation aimed at enhancing antioxidant status, (2) having undergone major surgical procedures within six months before study entry and (3) pregnant or lactating woman. All participants were provided a participant information sheet and received a thorough explanation from the investigator. Written informed consent was obtained from each participant. Potential risks, including food allergies, were communicated to participants during the consent process.
Supplementation
Demographic characteristics and participants' medical histories were collected during the baseline visit. Afterwards, participants began daily 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. The recommended intake dosage was communicated to participants upon their enrollment in the study. Participants prepared the beverages by mixing the contents of each sachet with 150 mL of lukewarm water and were instructed to consume it before meals. Three monthly follow-up visits were conducted. During each visit at weeks 0, 4, 8 and 12, a case report form (CRF) was utilized to gather information on vital signs, self-perceived general well-being and saliva samples for laboratory investigations. Participants were instructed to inform the research team immediately if they experienced adverse reactions to the tested supplement.
Laboratory Examinations 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). Inflammation levels were measured via IL-1beta, IL-6 and IL-10 biomarkers, using Elabsciecne ELISA Kit (Elabscience Biotechnology Co. Ltd, Texas, United States).
Vital Signs and General Wellbeing
Blood pressure and heart rate were measured using the Omron automatic blood pressure monitor HEM 7120 (Omron Healthcare, Kyoto, Japan). Temperature was measured using a Braun forehead infrared thermometer NTF 3000 (Braun GmbH, Kronberg, Germany). Visual Analogue Scale (VAS) was incorporated to self-evaluate their well-being. VAS is a psychometric instrument designed for participants to subjectively assess disease-related symptoms' severity or general well-being. It is a validated tool with demonstrated good validity and excellent reliability in evaluating general well-being and quality of life [35]. During the assessment, participants rated their condition on a 10-cm long horizontal VAS scale, where 0 points indicated the least healthy condition and 10 points indicated the most healthy condition.
- Conditions
- Antioxidant Capabilities, Inflammation Biomarkers
- Being tested
- Opuntia ficus-indica Supplementation
- Keywords
- Antioxidant capabilities, Inflammation levels, Opuntia ficus-indica, Oral supplementation, Reactive Oxygen Species (ROS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opuntia ficus-indica SupplementationDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Not described Receives: Dietary Supplement: Opuntia ficus-indica Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From enrollment to the end of intervention at 12 weeks
Secondary outcomes (4)
Vital Signs - Blood Pressure
Blood pressure were measured using the Omron automatic blood pressure monitor HEM 7120 (Omron Healthcare, Kyoto, Japan). The result is reported in the unit of millimeters of mercury (mmHg).
Measured: From enrollment to the end of intervention at 12 weeks
Vital Signs - Heart Rate
Heart rate were measured using the Omron automatic blood pressure monitor HEM 7120 (Omron Healthcare, Kyoto, Japan). Heart rate is expressed as beats per minute (BPM).
Measured: From enrollment to the end of intervention at 12 weeks
Vital Signs - Body Temperature
Temperature was measured using a Braun forehead infrared thermometer NTF 3000 (Braun GmbH, Kronberg, Germany). Body temperature is expressed in Celsius scale with the unit symbol °C.
Measured: From enrollment to the end of intervention at 12 weeks
General Wellbeing
Visual Analogue Scale (VAS) was incorporated to self-evaluate their well-being. VAS is a psychometric instrument designed for participants to subjectively assess disease-related symptoms' severity or general well-being. It is a validated tool with demonstrated good validity and excellent reliability in evaluating general well-being and quality of life. During the assessment, participants rated their condition on a 10-cm long horizontal VAS scale, where 0 points indicated the least healthy condition and 10 points indicated the most healthy condition.
Measured: From enrollment to the end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antioxidant CapabilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeTree Asia Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657963
- Sponsor's protocol ID
- LTA001
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request. Additional documents including study protocol, statistical analysis plan, informed consent form and clinical study report will also be made available. The data will be available immediately following publication with no end date. Data will be shared with anyone who wishes to access with reasonable request. The data can be used for any types of analyses.
Publications
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.
PubMed 35839856
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Opuntia Ficus-indica Supplementation on Improving Antioxidant and Inflammation Levels
- ClinicalTrials.gov ID
- NCT06657963
- Acronym / sponsor ID
- LTA001
- Conditions
- Antioxidant Capabilities, Inflammation Biomarkers
- Keywords
- Antioxidant capabilities, Inflammation levels, Opuntia ficus-indica, Oral supplementation, Reactive Oxygen Species (ROS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- LifeTree Asia Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does supplementation Opuntia ficus-indica improve the antioxidant status of the participants?
- Does supplementation Opuntia ficus-indica improve the inflammation levels of the participants?
Researchers will compare before and after intervention to see if supplementation Opuntia ficus-indica works to improve the antioxidant status and inflammation levels of the participants.
Participants will:
Take drug supplementation Opuntia ficus-indica every day for 12 weeks. Visit the clinic once every 4 weeks for checkups and tests
Detailed description
Study Design
This open-label, single-arm, prospective study involved a supplementation period of three months. The research was conducted in full compliance with the Declaration of Helsinki and the criteria outlined in Malaysian guidelines for Good Clinical Practice [76]. Participant eligibility was confirmed according to the protocol checklist, and written informed consent was obtained from all participants. The study received approval from the Institutional Ethics Committee, UCSI University, Malaysia, approval code is IEC-2022-FMHS-082.
Participants Selection
Participants were recruited through off-campus advertisements, and the study was conducted at UCSI University in Kuala Lumpur, Malaysia. The inclusion criteria were as follows: (1) generally healthy individually; (2) aged 18 years and above; (3) capable of understanding the study protocol and information; and (4) willing to provide informed consent. Exclusion criteria included: (1) currently undergoing supplementation aimed at enhancing antioxidant status, (2) having undergone major surgical procedures within six months before study entry and (3) pregnant or lactating woman. All participants were provided a participant information sheet and received a thorough explanation from the investigator. Written informed consent was obtained from each participant. Potential risks, including food allergies, were communicated to participants during the consent process.
Supplementation
Demographic characteristics and participants' medical histories were collected during the baseline visit. Afterwards, participants began daily 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. The recommended intake dosage was communicated to participants upon their enrollment in the study. Participants prepared the beverages by mixing the contents of each sachet with 150 mL of lukewarm water and were instructed to consume it before meals. Three monthly follow-up visits were conducted. During each visit at weeks 0, 4, 8 and 12, a case report form (CRF) was utilized to gather information on vital signs, self-perceived general well-being and saliva samples for laboratory investigations. Participants were instructed to inform the research team immediately if they experienced adverse reactions to the tested supplement.
Laboratory Examinations 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). Inflammation levels were measured via IL-1beta, IL-6 and IL-10 biomarkers, using Elabsciecne ELISA Kit (Elabscience Biotechnology Co. Ltd, Texas, United States).
Vital Signs and General Wellbeing
Blood pressure and heart rate were measured using the Omron automatic blood pressure monitor HEM 7120 (Omron Healthcare, Kyoto, Japan). Temperature was measured using a Braun forehead infrared thermometer NTF 3000 (Braun GmbH, Kronberg, Germany). Visual Analogue Scale (VAS) was incorporated to self-evaluate their well-being. VAS is a psychometric instrument designed for participants to subjectively assess disease-related symptoms' severity or general well-being. It is a validated tool with demonstrated good validity and excellent reliability in evaluating general well-being and quality of life [35]. During the assessment, participants rated their condition on a 10-cm long horizontal VAS scale, where 0 points indicated the least healthy condition and 10 points indicated the most healthy condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Dietary Supplement: Opuntia ficus-indica Supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- generally healthy individually
- aged 18 years and above
- capable of understanding the study protocol and information
- willing to provide informed consent.
Key exclusion criteria (3 listed)
- currently undergoing supplementation aimed at enhancing antioxidant status
- having undergone major surgical procedures within six months before study entry
- pregnant or lactating woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opuntia ficus-indica SupplementationParticipants 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. | Dietary supplement | Interventional Arm |
Primary outcome
Antioxidant Status
Time frame: From enrollment to the end of intervention at 12 weeks
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).
Inflammation Levels
Time frame: From enrollment to the end of intervention at 12 weeks
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).
4 secondary outcomes
Vital Signs - Blood Pressure
Time frame: From enrollment to the end of intervention at 12 weeks
Vital Signs - Heart Rate
Time frame: From enrollment to the end of intervention at 12 weeks
Vital Signs - Body Temperature
Time frame: From enrollment to the end of intervention at 12 weeks
General Wellbeing
Time frame: From enrollment to the end of intervention at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 35839856Martemucci 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.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request. Additional documents including study protocol, statistical analysis plan, informed consent form and clinical study report will also be made available. The data will be available immediately following publication with no end date. Data will be shared with anyone who wishes to access with reasonable request. The data can be used for any types of analyses.
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Inflammation Biomarkers, Cardiometabolic Health Indicators
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opuntia ficus-indica Supplementation in people with Antioxidant Capabilities and Inflammation Biomarkers, run by LifeTree Asia Sdn Bhd at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant Status (time frame: From enrollment to the end of intervention at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06657963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.