Characterization of Red Dragon Fruit Peel Powder and Its Potential Role in Improving Vascular Function in Patients With Cardiometabolic Disorders

November 7, 2026 updated by: University of Lahore

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both genders (men and women), aged 35-70 years.
  • Participants who provide informed consent.
  • Participants with BMI ≥ 25.0 kg/m².
  • Participants with diagnosed cardiometabolic disorder (type 2 diabetes, hypertension, or dyslipidemia).
  • Participants with HbA1c between 6.5-9.0%.
  • Participants with fasting plasma glucose 126-200 mg/dL.
  • Participants with SBP 130-159 mmHg and/or DBP 80-99 mmHg.
  • Participants with Total cholesterol > 200 mg/dL, LDL-C > 130 mg/dL, or HDL-C < 40 mg/dL (men) / < 50 mg/dL (women).
  • Participants with Triglycerides > 150 mg/dL.
  • Participants with hs-CRP > 3.0 mg/L.
  • Participants with measurable IL-6 or MDA above reference range.
  • Participants with reduced FMD or elevated PWV/Augmentation Index compared to age norms.
  • Participants with liver enzymes (ALT, AST, ALP) ≤2.5× ULN and bilirubin <2× ULN.
  • Participants with renal function eGFR ≥ 45 mL/min/1.73m².
  • Participants with complete blood count within acceptable clinical range.
  • Participants on stable medication doses for ≥8 weeks prior to enrollment.
  • Participants willing to follow study diet and physical activity monitoring.

Exclusion Criteria:

  • Participants with severe uncontrolled medical conditions such as advanced heart failure, end-stage renal disease, active malignancy, or chronic liver disease will be excluded.
  • Individuals currently taking high-dose antioxidant supplements, herbal nutraceuticals, or experimental therapies that may interfere with study outcomes will not be included.
  • Pregnant or breastfeeding women will be excluded to avoid potential risks and confounding effects.
  • Participants with known allergies or hypersensitivity to dragon fruit or related plant products will not be enrolled.
  • Individuals unable or unwilling to consume the Red Dragon Fruit peel powder or adhere to the DASH diet during the intervention period will be excluded.
  • Participants with poor compliance history in previous clinical studies or those unable to commit to scheduled follow-ups will not be considered.
  • Patients with recent major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO T0

Participants will take a standard placebo shot of red dragon fruit accompanied by DASH diet and conventional treatment.
Behavioral: Placebo

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.
Experimental: Intervention Group (T₁)

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 4g of its peel powder accompanied by DASH diet along with conventional treatment.
Experimental: Intervention Group (T₂)

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 6g of its peel powder accompanied by DASH diet along with conventional treatment
Experimental: Intervention Group (T3)

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 placebo shot of red dragon fruit containing 8g of its peel powder accompanied by DASH diet along with conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension
Time Frame: 12 weeks

Blood pressure will be measured in hypertensive patients using a calibrated digital sphygmomanometer and recorded in mmHg after standardized seated rest.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid Profile
Time Frame: 12 weeks

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
12 weeks
Liver Enzymes
Time Frame: 12 Weeks

Liver enzymes (ALT, AST, and ALP) will be measured using an automated clinical chemistry analyzer, with results expressed in U/L.
12 Weeks
Fasting Blood glucose
Time Frame: 12 Weeks

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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

November 7, 2026

First Submitted That Met QC Criteria

November 7, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 7, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UOL/REB/26/22/03/0014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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