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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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