Cardiac AbnormalitiesNCT07609524
Alleviation of Cardiometabolic Risk Factors Through Watermelon Rind
A study testing Experimental G1 on WRB and Experimental G2 on WRB in people with Cardiac Abnormalities, run by University of Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Cardiac Abnormalities
- What is being tested?
- Experimental G1 on WRB and Experimental G2 on WRB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jun 2025to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Abnormalities
- Being tested
- Control on Wheat bread, Experimental G1 on WRB, Experimental G2 on WRB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control on Wheat breadDietary supplement
Participants were advised to take Two slices of wheat bread in breakfast for the duration of 02 months.
Experimental G1 on WRBDietary supplement
Participants were advised to take 2 slices of Watermelon rind-based bread in breakfast for the duration of 02 months.
Experimental G2 on WRBDietary supplement
Group 2: Participants were advised to take 2 slices of Watermelon rind-based bread in breakfast for the duration of 02 months.
| Study group | Role | What they receive |
|---|---|---|
| Control group on whole wheat bread | Placebo comparator | Participants were only subjected to use Wheat bread in breakfast. Receives: Dietary Supplement: Control on Wheat bread |
| G1 on 40% WRB | Experimental | Participants were advised to take Watermelon rind-based bread (40% ) in breakfast for the duration of 02 months. Receives: Dietary Supplement: Experimental G1 on WRB |
| G 2 on 60% WRB | Experimental | Participants were advised to take Watermelon rind-based bread (60% ) in breakfast for the duration of 02 month. Receives: Dietary Supplement: Experimental G2 on WRB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric Measurements
for body mass index weight in kg and height in meters squared, were used to calculate changes in body size.
Measured: 60 days
Lipid Profile
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.
Measured: 60 days
Blood pressure
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start12 Jun 2025
- Primary completion19 Aug 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac AbnormalitiesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aslam, University of Lahore
- Investigators
- Maria Aslam, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609524
- Sponsor's protocol ID
- IRB-UOL-FAHS/837/2024
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karimi E, Abaj F, Gholizadeh M, Asbaghi O, Amini MR, Ghaedi E, Hadi A. Watermelon consumption decreases risk factors of cardiovascular diseases: A systematic review and meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2023 Aug;202:110801. doi: 10.1016/j.diabres.2023.110801. Epub 2023 Jun 25.
PubMed 37369281
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviation of Cardiometabolic Risk Factors Through Watermelon (Citrullus Lanatus (Thunb.) Matsum. &Amp; Nakai) Rind-based Bread Among Cardiac Patients
- ClinicalTrials.gov ID
- NCT07609524
- Acronym / sponsor ID
- IRB-UOL-FAHS/837/2024
- Conditions
- Cardiac Abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 27 May 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group on whole wheat bread | Placebo comparator | Dietary Supplement: Control on Wheat breadParticipants were only subjected to use Wheat bread in breakfast. |
| G1 on 40% WRB | Experimental | Dietary Supplement: Experimental G1 on WRBParticipants were advised to take Watermelon rind-based bread (40% ) in breakfast for the duration of 02 months. |
| G 2 on 60% WRB | Experimental | Dietary Supplement: Experimental G2 on WRBParticipants were advised to take Watermelon rind-based bread (60% ) in breakfast for the duration of 02 month. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%)
Key exclusion criteria (4 listed)
- Any person allergic to wheat.
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 |
|---|---|---|
| Control on Wheat breadParticipants were advised to take Two slices of wheat bread in breakfast for the duration of 02 months. | Dietary supplement | Control group on whole wheat bread |
| Experimental G1 on WRBParticipants were advised to take 2 slices of Watermelon rind-based bread in breakfast for the duration of 02 months. | Dietary supplement | G1 on 40% WRB |
| Experimental G2 on WRBGroup 2: Participants were advised to take 2 slices of Watermelon rind-based bread in breakfast for the duration of 02 months. | Dietary supplement | G 2 on 60% WRB |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publication: PubMed 37369281Karimi E, Abaj F, Gholizadeh M, Asbaghi O, Amini MR, Ghaedi E, Hadi A. Watermelon consumption decreases risk factors of cardiovascular diseases: A systematic review and meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2023 Aug;202:110801. doi: 10.1016/j.diabres.2023.110801. Epub 2023 Jun 25.
- 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. This study is not recruiting at the moment.
Maria Aslam principal investigator
University of Lahore
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 G1 on WRB and Experimental G2 on WRB in people with Cardiac Abnormalities, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 27 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric Measurements (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07609524, which also lists 1 linked publication.
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 27 May 2026.