- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07609524
Alleviation of Cardiometabolic Risk Factors Through Watermelon Rind
May 19, 2026 updated by: Maria Aslam, University of Lahore
Alleviation of Cardiometabolic Risk Factors Through Watermelon (Citrullus Lanatus (Thunb.) Matsum. &Amp; Nakai) Rind-based Bread Among Cardiac Patients
To collect data, written consent was obtained from the hospital and university administration.
After receiving signed informed consent, the data was collected from cardiac patients.
Study Overview
Status
Completed
Conditions
Detailed Description
The target population was adults between the ages of 35 and 65 years who were receiving outpatient care at a hospital or clinic with a diagnosis of either mild to moderate hypertension, mild to moderate alterations in lipid profile or pre-diabetes.
To select potential participants from the study population, subjects with a medical history of diabetes, measuring fasting blood glucose, lipid profile and blood pressure were screened.Following screening, participants were divided evenly into three groups: experimental group (1, 2) and one control group.
The participants were advised to take 2 slices of bread in breakfast.
Individualized plans were given according to their nutrient requirements.
A systematic communication plan was developed in order to follow up with participants on their daily consumption of the suggested watermelon rind-based bread through telephonic conversations.
For continuous assistance there was a WhatsApp group set up where members may ask issues and get help.
The follow up for patients were conducted every month; baseline and after 6 pre-treatments.
Appointments for follow-up exams were done after every 15 days in order to track developments, anthropometric measurements were calculated every follow up and modify the dosage as necessary.
The baseline and post study test was compared to test the hypothesis.
Study Type
Interventional
Enrollment (Actual)
120
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 Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- University of Lahore
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The inclusion criterion was target adults with both gender aged 35-65 years. Adults with a diagnosis of mild to moderate hypertension Mild hypertension (140-159/90-99 mm Hg) Moderate hypertension (160-179/100-109 mm Hg) Adults having mild to moderate alterations in lipid profile Triglycerides: 150 to 499 mg/dL LDL-C levels: Mild Alteration (130 to 159 mg/dL) and Moderate Alteration (160 to 189 mg/dL) Adults with pre-diabetes (hbA1c= 5.6-6.4%)
Exclusion Criteria:
Any person allergic to wheat.
- Any person any person allergic to watermelon rind.
- Any adult having pancreatitis and hepatitis.
- Any adults having serious health conditions like cancer.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group on whole wheat bread
Participants were only subjected to use Wheat bread in breakfast.
|
Participants were advised to take Two slices of wheat bread in breakfast for the duration of 02 months.
|
|
Experimental: G1 on 40% WRB
Participants were advised to take Watermelon rind-based bread (40% ) in breakfast for the duration of 02 months.
|
Participants were advised to take 2 slices of Watermelon rind-based bread in breakfast for the duration of 02 months.
|
|
Experimental: G 2 on 60% WRB
Participants were advised to take Watermelon rind-based bread (60% ) in breakfast for the duration of 02 month.
|
Group 2: Participants were advised to take 2 slices of Watermelon rind-based bread in breakfast for the duration of 02 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric Measurements
Time Frame: 60 days
|
for body mass index weight in kg and height in meters squared, were used to calculate changes in body size.
|
60 days
|
|
Lipid Profile
Time Frame: 60 days
|
Blood lipid profile was obtained using fasting blood samples to determine serum total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were monitored pre and post intervention.
|
60 days
|
|
Blood pressure
Time Frame: 60 days
|
Blood pressure was checked using an automated sphygmomanometer.
Sitting blood pressure was measured in two ways; systolic blood pressure and diastolic blood pressure after 5 minutes rest.
For analysis, the average of the three readings were taken.
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria Aslam, 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.
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 (Actual)
June 12, 2025
Primary Completion (Actual)
August 19, 2025
Study Completion (Actual)
September 20, 2025
Study Registration Dates
First Submitted
May 8, 2026
First Submitted That Met QC Criteria
May 19, 2026
First Posted (Actual)
May 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 19, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- IRB-UOL-FAHS/837/2024
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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