Lipid ProfileNCT07903103
Prickly Pear Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
A study testing Experimental in people with Lipid Profile and Blood Glucose, run by University of Lahore at 1 site in Pakistan.
Trial summary
This RCT will evaluate the 12-week therapeutic effects of prickly pear pulp powder lozenges (0.5, 1.0, and 1.5 g/day) combined with an anti-inflammatory diet in adults with liver fibrosis (F1-F3). Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Profile, Blood Glucose, Liver Enzymes
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Dec 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both gender (men and women) will be selected, aged 45 year to 60 year.
- Participants in the study who give their informed consent.
- Participants whose BMI (Body Mass Index) is above 25.9 kg/m2 will be included.
- Patients with positive Liver Fibrosis diagnosis will be selected.
- Participants with Total Protein above or below the normal range of 6.0 and 8.3 g/dL will be included
- Participants with ALT (Alanine Aminotransferase) above 5 to 40 U/L will be included
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- Participants with ALP (Alkaline Phosphatase) above 40 - 129 U/L will be included
- Participants with AST (Aspartate Aminotransferase) above 10 - 50 U/L will be included
- Participants serum GGT (Gamma-glutamyl Transferase) above 8 to 61 U/L will be included
- Participants with CRP (C-Reactive Protein) above less than 1.0 mg/L will be included
- Participants Serum Albumin below 3.4 to 5.4 g/dL will be included
- Participants Total cholesterol above 240 mg/dL will be included
- Participants with Vitamin D3 below 21-100 ng/mL will be included
Who cannot join
- Individuals who have a known allergy or have experienced any adverse reaction to prickly pear pulp powder or any of the ingredients used in the lozenges will not be included in the study.
- Patients who are taking medications known to significantly alter fatty liver of other liver functions.
- Individuals who have recently had liver transplant surgery or injury.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Sana Noreen
Lahore, Punjab Province, 54000
sana noreen, phd, 03018661160, sana.noreen@dnsc.uol.edu.pk
About this study
Official title: Hepatoprotective Effects of Prickly Pear (Opuntia Ficus-indica (L.) Mill) Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
This RCT will evaluate the 12-week therapeutic effects of prickly pear pulp powder lozenges (0.5, 1.0, and 1.5 g/day) combined with an anti-inflammatory diet in adults with liver fibrosis (F1-F3).
Changes in ALT, AST, ALP, GGT, bilirubin, and clinical outcomes will be assessed to determine its potential as a safe, affordable, and hepatoprotective nutraceutical.
Read the detailed description
Liver fibrosis, a progressive outcome of chronic liver damage, represents a major and expanding issue affecting people's well-being, particularly in nations with limited resources like Pakistan. Although conventional treatments offer some benefits, they are often expensive, less accessible, and associated with adverse effects. This has led to rising interest in nutraceutical and plant-based therapies that provide safer, multifunctional alternatives. Opuntia ficus-indica (prickly pear cactus) is abundant in bioactive compounds such as betalains, flavonoids (quercetin, kaempferol, isorhamnetin), vitamin C, and polyphenols, which possess strong antioxidant, anti-inflammatory, hypoglycemic, and hepatoprotective activities. By regulating oxidative stress, redox balance, and lipid metabolism, Opuntia extracts may reduce hepatic steatosis and oxidative injury, highlighting its potential as a nutraceutical strategy for chronic liver disorders. This RCT is designed to investigate the therapeutic efficacy of prickly pear pulp powder in patients with liver fibrosis. The study will be conducted at the Food Science and Nutrition Laboratory, University of Lahore. Prickly pear pulp will be sourced from certified herbal suppliers will be dried, ground, and brewed to prepare the powder in the form of lozenges. Each lozenge produced will contain 0.5 g of prickly pear pulp powder. Treatment plan will be executed as follows: T1= 0.5g, T2=1g and T3=1.5g to patients along with anti-inflammatory dietary intervention. Patients (men and women aged 45-60) with clinically confirmed liver fibrosis (F1-F3, via transient elastography) will be enrolled and assigned into four intervention groups randomly. Participants will consume prickly pear pulp powder lozenges daily for 12 weeks. Biochemical and clinical assessments will be conducted pre- and post-intervention, including liver function tests (ALT, AST, ALP, GGT, bilirubin). Statistical analysis will be performed using SPSS, with a significance threshold of p < 0.05. Preliminary evidence suggests that prickly pear pulp powder may serve as a safe, cost-effective hepatoprotective agent, potentially reducing fibrosis progression and enhancing liver function in affected individuals.
- Conditions
- Lipid Profile, Blood Glucose, Liver Enzymes
- Being tested
- Experimental, Placebo
- Keywords
- Liver Fibrosis, hepato-protective, anti-inflammatory
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDietary supplement
1 Lozenge (0.5 gm Prickly Pear Pulp Powder)
+ Anti Inflammatory Diet + Conventional Treatment once a day
ExperimentalDietary supplement
2 Lozenges (0.5 gm Prickly Pear Pulp Powder) 1+1
- Anti Inflammatory Diet
- Conventional Treatment
ExperimentalDietary supplement
3 Lozenges (0.5 gm Prickly Pear Pulp Powder)
- Anti Inflammatory Diet
- Conventional Treatment
PlaceboOther
SIMPLE LOZENGESE
| Study group | Role | What they receive |
|---|---|---|
| (T₁) 0.5 gm Prickly Pear Pulp Powder | Experimental | 1 Lozenge (0.5 gm Prickly Pear Pulp Powder)
+ Anti Inflammatory Diet + Conventional Treatment Receives: Dietary Supplement: Experimental |
| (T₂) 0.5 gm Prickly Pear Pulp Powder | Experimental | 2 Lozenges (0.5 gm Prickly Pear Pulp Powder) 1+1
* Anti Inflammatory Diet
* Conventional Treatment Receives: Dietary Supplement: Experimental |
| (T3) 0.5 gm Prickly Pear Pulp Powder) | Experimental | 3 Lozenges (0.5 gm Prickly Pear Pulp Powder)
* Anti Inflammatory Diet
* Conventional Treatment Receives: Dietary Supplement: Experimental |
| Placebo Group (T₀) simple lozenges | Placebo comparator | simple lozenges Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
anthropometric measurement
weight (Kg)
Measured: 12 weeks
Liver Enzymes
ALT, AST, ALP, and GGT are commonly reported in U/L
Measured: 12 weeks
Glucose
Fasting glucose is reported in mg/dL, while HbA1c is reported as %.
Measured: 12 weeks
BMI (kg/m^2)
Measured: 12 WEEKS
Secondary outcomes (1)
lipid profile
Lipid profile parameters are generally reported as TC, TG, LDL-C, and HDL-C in mg/dL.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid ProfileStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903103
- Sponsor's protocol ID
- UOL/IREB/26/22/03/0015
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatoprotective Effects of Prickly Pear (Opuntia Ficus-indica (L.) Mill) Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
- ClinicalTrials.gov ID
- NCT07903103
- Acronym / sponsor ID
- UOL/IREB/26/22/03/0015
- Conditions
- Lipid Profile, Blood Glucose, Liver Enzymes
- Keywords
- Liver Fibrosis, hepato-protective, anti-inflammatory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Oct 2026 (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.
This RCT will evaluate the 12-week therapeutic effects of prickly pear pulp powder lozenges (0.5, 1.0, and 1.5 g/day) combined with an anti-inflammatory diet in adults with liver fibrosis (F1-F3).
Changes in ALT, AST, ALP, GGT, bilirubin, and clinical outcomes will be assessed to determine its potential as a safe, affordable, and hepatoprotective nutraceutical.
Detailed description
Liver fibrosis, a progressive outcome of chronic liver damage, represents a major and expanding issue affecting people's well-being, particularly in nations with limited resources like Pakistan. Although conventional treatments offer some benefits, they are often expensive, less accessible, and associated with adverse effects. This has led to rising interest in nutraceutical and plant-based therapies that provide safer, multifunctional alternatives. Opuntia ficus-indica (prickly pear cactus) is abundant in bioactive compounds such as betalains, flavonoids (quercetin, kaempferol, isorhamnetin), vitamin C, and polyphenols, which possess strong antioxidant, anti-inflammatory, hypoglycemic, and hepatoprotective activities. By regulating oxidative stress, redox balance, and lipid metabolism, Opuntia extracts may reduce hepatic steatosis and oxidative injury, highlighting its potential as a nutraceutical strategy for chronic liver disorders. This RCT is designed to investigate the therapeutic efficacy of prickly pear pulp powder in patients with liver fibrosis. The study will be conducted at the Food Science and Nutrition Laboratory, University of Lahore. Prickly pear pulp will be sourced from certified herbal suppliers will be dried, ground, and brewed to prepare the powder in the form of lozenges. Each lozenge produced will contain 0.5 g of prickly pear pulp powder. Treatment plan will be executed as follows: T1= 0.5g, T2=1g and T3=1.5g to patients along with anti-inflammatory dietary intervention. Patients (men and women aged 45-60) with clinically confirmed liver fibrosis (F1-F3, via transient elastography) will be enrolled and assigned into four intervention groups randomly. Participants will consume prickly pear pulp powder lozenges daily for 12 weeks. Biochemical and clinical assessments will be conducted pre- and post-intervention, including liver function tests (ALT, AST, ALP, GGT, bilirubin). Statistical analysis will be performed using SPSS, with a significance threshold of p < 0.05. Preliminary evidence suggests that prickly pear pulp powder may serve as a safe, cost-effective hepatoprotective agent, potentially reducing fibrosis progression and enhancing liver function in affected individuals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (T₁) 0.5 gm Prickly Pear Pulp Powder | Experimental | Dietary Supplement: Experimental1 Lozenge (0.5 gm Prickly Pear Pulp Powder) + Anti Inflammatory Diet + Conventional Treatment |
| (T₂) 0.5 gm Prickly Pear Pulp Powder | Experimental | Dietary Supplement: Experimental2 Lozenges (0.5 gm Prickly Pear Pulp Powder) 1+1 * Anti Inflammatory Diet * Conventional Treatment |
| (T3) 0.5 gm Prickly Pear Pulp Powder) | Experimental | Dietary Supplement: Experimental3 Lozenges (0.5 gm Prickly Pear Pulp Powder) * Anti Inflammatory Diet * Conventional Treatment |
| Placebo Group (T₀) simple lozenges | Placebo comparator | Other: Placebosimple lozenges |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Both gender (men and women) will be selected, aged 45 year to 60 year.
- Participants in the study who give their informed consent.
- Participants whose BMI (Body Mass Index) is above 25.9 kg/m2 will be included.
- Patients with positive Liver Fibrosis diagnosis will be selected.
- Participants with Total Protein above or below the normal range of 6.0 and 8.3 g/dL will be included
Key exclusion criteria (3 listed)
- Individuals who have a known allergy or have experienced any adverse reaction to prickly pear pulp powder or any of the ingredients used in the lozenges will not be included in the study.
- Patients who are taking medications known to significantly alter fatty liver of other liver functions.
- Individuals who have recently had liver transplant surgery or injury.
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 |
|---|---|---|
| Experimental1 Lozenge (0.5 gm Prickly Pear Pulp Powder) + Anti Inflammatory Diet + Conventional Treatment once a day | Dietary supplement | (T₁) 0.5 gm Prickly Pear Pulp Powder |
| Experimental2 Lozenges (0.5 gm Prickly Pear Pulp Powder) 1+1 * Anti Inflammatory Diet * Conventional Treatment | Dietary supplement | (T₂) 0.5 gm Prickly Pear Pulp Powder |
| Experimental3 Lozenges (0.5 gm Prickly Pear Pulp Powder) * Anti Inflammatory Diet * Conventional Treatment | Dietary supplement | (T3) 0.5 gm Prickly Pear Pulp Powder) |
| PlaceboSIMPLE LOZENGESE | Other | Placebo Group (T₀) simple lozenges |
Primary outcome
anthropometric measurement
Time frame: 12 weeks
weight (Kg)
Liver Enzymes
Time frame: 12 weeks
ALT, AST, ALP, and GGT are commonly reported in U/L
Glucose
Time frame: 12 weeks
Fasting glucose is reported in mg/dL, while HbA1c is reported as %.
BMI (kg/m^2)
Time frame: 12 WEEKS
1 secondary outcome
lipid profile
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Lipid Profile and Blood Glucose, run by University of Lahore at 1 site in Pakistan.
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 13 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sana noreen, PhD (03018661160, sana.noreen@dnsc.uol.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anthropometric measurement (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.