An interventional study of Placebo and DRAGON FRUIT PEEL (4g) in Cardiometabolic Conditions, sponsored by University of Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by University of Lahore · Not applicable, Interventional, and Health services research
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This study aims to characterize red dragon fruit (Selenicereus undatus) peel powder by evaluating its nutritional, physicochemical, and phytochemical properties. It will also explore its potential role in improving vascular function and cardiometabolic health among patients with cardiometabolic disorders.
Cardiometabolic disorders including hypertension, dyslipidemia, and type 2 diabetes are strongly linked with vascular dysfunction, which increases the risk of cardiovascular morbidity and mortality. Conventional pharmacological therapies target metabolic abnormalities but often come with side effects, variable patient compliance, and limited improvement in vascular function. This has generated increasing interest in plant-derived nutraceuticals rich in bioactive compounds with antioxidant and endothelial-protective potential. Red Dragon Fruit (Selenicereus undatus (Haworth) D.R. Hunt) peel, usually considered an agro-waste, contains abundant betalains, flavonoids, dietary fiber, and essential minerals that may improve endothelial nitric oxide bioavailability, reduce oxidative stress, and modulate inflammatory pathways. This study aims to characterize the physicochemical and phytochemical profile of standardized dragon fruit peel powder and evaluate its potential role in improving vascular health in patients with cardiometabolic disorders. The intervention will involve daily supplementation with 4g, 6g and 8g of dragon fruit peel powder provided in a food-based vehicle along with DASH diet to three different groups over a period of 12 weeks. The study will enroll 90 adult participants aged 35-70 years diagnosed with at least one cardiometabolic disorder from CMH Hospital Lahore. Participants will be randomized into an intervention group receiving dragon fruit peel powder or a placebo group. Baseline and post-intervention assessments will include flow-mediated dilation (FMD), blood pressure, fasting glucose, HbA1c, lipid profile, inflammatory markers (hs-CRP, IL-6), and oxidative stress indicators (MDA, TAC). Statistical analysis will be performed using SPSS with significance set at p \< 0.05. This study intends to establish Red Dragon Fruit peel as a safe, cost-effective, and sustainable dietary strategy for vascular health improvement and cardiometabolic risk reduction.
University of Lahore is the lead sponsor of 234 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will take a standard placebo shot of red dragon fruit accompanied by DASH diet and conventional treatment.
Behavioral: Placebo
Participants will take a placebo shot of red dragon fruit containing 4g of its peel powder accompanied by DASH diet along with conventional treatment
Dietary Supplement: DRAGON FRUIT PEEL (4g)
Participants will take a placebo shot of red dragon fruit containing 6g of its peel powder accompanied by DASH diet along with conventional treatment.
Dietary Supplement: Dragon fruit peel (6g)
Participants will take a placebo shot of red dragon fruit containing 8g of its peel powder accompanied by DASH diet along with conventional treatment.
Dietary Supplement: Dragon fruit peel (8g)
Participants will take a standard placebo shot of red dragon fruit (Selenicereus undatus (Haworth) D.R. Hunt) accompanied by regular balanced diet and conventional treatment.
Participants will take a placebo shot of red dragon fruit containing 4g of its peel powder accompanied by DASH diet along with conventional treatment.
Participants will take a placebo shot of red dragon fruit containing 6g of its peel powder accompanied by DASH diet along with conventional treatment
Participants will take a placebo shot of red dragon fruit containing 8g of its peel powder accompanied by DASH diet along with conventional treatment
Hypertension
Blood pressure will be measured in hypertensive patients using a calibrated digital sphygmomanometer and recorded in mmHg after standardized seated rest.
Time frame: 12 weeks
Lipid Profile
Lipid profile (total cholesterol, triglycerides, HDL-C, and LDL-C) will be assessed using an automated clinical chemistry analyzer, with results expressed in mg/dL
Time frame: 12 weeks
Liver Enzymes
Liver enzymes (ALT, AST, and ALP) will be measured using an automated clinical chemistry analyzer, with results expressed in U/L.
Time frame: 12 Weeks
Fasting Blood glucose
Fasting blood glucose will be measured using an automated clinical chemistry analyzer from venous blood samples collected after 8-12 hours of fasting, with results expressed in mg/dL.
Time frame: 12 Weeks
Plan to share: No
Start is estimated for Dec 2026; primary completion for Mar 2027, 3 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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