Hypertension (HTN)NCT07145710
Raw Banana Flour-Enriched Muffins for Hypertensive Patients
A study testing Whole wheat muffin, Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF) and Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF) in people with Hypertension (HTN) and Lipid Profile, run by University of Lahore at 1 site in Pakistan.
Trial summary
This study evaluated the effects of raw banana flour (RBF)-enriched muffins on hypertensive patients in Lahore, Pakistan. A total of 34 patients were divided into three groups: a control group and two intervention groups receiving muffins with 35% (C1) or 40% (C2) RBF for 10 weeks. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Hypertension (HTN), Lipid Profile, Liver Enzymes
- What is being tested?
- Whole wheat muffin, Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF) and Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Aug 2024to 20 Oct 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The study included men and women between the ages of 35 and 55.
- who had high levels of total cholesterol (>220 mg/dL), total triglycerides (>150 mg/dL), and low-density lipoprotein (>130 mg/dL).
Who cannot join
- People with diabetes, serious diseases, or surgeries in the last three months, or other conditions that might produce high cholesterol, were not allowed to take part.
- People who had gastrointestinal problems or were known to be allergic to cinnamon were also not accepted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of Raw Banana Flour-Enriched Muffins for Hypertensive Patients: A Pilot Study
This study evaluated the effects of raw banana flour (RBF)-enriched muffins on hypertensive patients in Lahore, Pakistan. A total of 34 patients were divided into three groups: a control group and two intervention groups receiving muffins with 35% (C1) or 40% (C2) RBF for 10 weeks. Sensory evaluation showed high acceptability of the 35% RBF muffins, comparable to control muffins. Clinical outcomes indicated that both intervention groups experienced improvements in body weight, BMI, blood pressure, liver enzymes, and lipid profiles, with more pronounced benefits observed in the 40% RBF group. The findings suggest that RBF-enriched muffins, particularly at 40% substitution, can offer functional, nutritional, and clinical benefits for individuals with hypertension.
Read the detailed description
- Materials and Methods The study received ethical approval from the University of Lahore (REC-UOL/466/08/24). Informed consent was obtained from all participants, who were fully informed about the study's aims, methods, risks, and benefits, and were allowed to ask questions and withdraw at any time.
2.2. Materials Raw banana flour, whole wheat flour, brown sugar, baking powder, pink salt, coconut oil, vanilla essence, cinnamon powder, eggs, and plastic bags were procured from the local market of Lahore, Pakistan, and subsequently stored in the Food Science and Nutrition Lab at the University Institute of Diet and Nutritional Sciences (UIDNS), University of Lahore, Pakistan. Standard kits from Merck Specialities Pvt. Ltd. were employed to assess liver enzyme tests and lipid profiles.
2.3. Settings: This study took place at the Food Science and Nutrition Lab, UIDNS, University of Lahore, and Nutrition Department, Noor Hospital Lahore, Lahore, Pakistan.
2.4. Sensory Evaluation Muffins were tasted by 10 professionals. Randomly placed muffins have two-digit codes. Cookies with two-digit numbers were distributed randomly. The panelists used a 9-point hedonic scale (9 = highly liked; 1 = severely disliked) to rate color, appearance, flavor, texture, overall acceptability, and affordability (Wichchukit \& O'Mahony, 2015). During sensory evaluation, panelists cleaned their taste receptors with mineral water and expectorant cups (Handa et al., 2012).
2.5. Subjects In this pilot study, 48 patients signed up; however, 6 of them were not allowed to participate because they did not meet the requirements (Figure 1). We randomly put 42 patients into three groups. There were three groups of 42 patients, each with the same number of people. There were 14 people in each group. Four people were left out of the control group (C0) because of some personal issues. Two people were taken out of the intervention group (C1) because they had to travel, were constipated, or started using an alternative medicine. Two other people moved from the intervention group (C2) to start taking an alternative medicine. Figure 1 shows that 10 patients were in the control group, 12 were in the intervention group (C1), and 12 were in the other intervention group (C2). All of them finished the trial and were tested after 10 weeks, lipid profile and liver enzymes were assessed at the end of study.
2.6 2.9. Statistical analysis All sensory evaluation data were expressed as mean ± standard deviation (SD). One-way analysis of variance (ANOVA) was performed to determine significant differences among the control and raw banana flour-enriched muffin sample groups for each sensory attribute (Steel \& Torrie, 1981).
- Conditions
- Hypertension (HTN), Lipid Profile, Liver Enzymes
- Being tested
- Whole wheat muffin, Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF), Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF)
- Keywords
- Hypertension, dietary fiber, bioactive compounds, cardiovascular health, functional food, intervention, muffins
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole wheat muffinDietary supplement
Participants received Whole wheat muffin once a day
Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF)Dietary supplement
Participants received Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF)
Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF)Dietary supplement
Participants received Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF)
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Patients received Whole wheat muffin Receives: Dietary Supplement: Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF) |
| 17.5g RBF Group | Experimental | Whole wheat muffin enriched with raw banana flower (RBF) (contains 17.5g RBF) Receives: Dietary Supplement: Whole wheat muffin |
| 20 g RBF Group | Experimental | Whole wheat muffin enriched with raw banana flower (RBF) (contains 20g RBF) Receives: Dietary Supplement: Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Profile
Level of total cholesterol (mg/dL), total triglycerides (mg/dL), and low-density lipoprotein (mg/dL) were measure.
Measured: 10 Weeks
Blood Pressure (systolic pressure and diastolic pressure)
Level of Blood pressure was observed among hypertensive patients
Measured: 10 Weeks
Secondary outcomes (1)
Liver Enzymes
Level of Liver function enzymes were observed among participants
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start8 Aug 2024
- Primary completion18 Oct 2024
- Study completion20 Oct 2024
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 Hypertension (HTN)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Noreen, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145710
- Sponsor's protocol ID
- REC-UOL/466/08/24
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amini Khoozani A, Kebede B, Birch J, Bekhit AEA. The Effect of Bread Fortification with Whole Green Banana Flour on Its Physicochemical, Nutritional and In Vitro Digestibility. Foods. 2020 Feb 5;9(2):152. doi: 10.3390/foods9020152.
PubMed 32033343
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Raw Banana Flour-Enriched Muffins for Hypertensive Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT07145710
- Acronym / sponsor ID
- REC-UOL/466/08/24
- Conditions
- Hypertension (HTN), Lipid Profile, Liver Enzymes
- Keywords
- Hypertension, dietary fiber, bioactive compounds, cardiovascular health, functional food, intervention, muffins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 28 Aug 2025 (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.
This study evaluated the effects of raw banana flour (RBF)-enriched muffins on hypertensive patients in Lahore, Pakistan. A total of 34 patients were divided into three groups: a control group and two intervention groups receiving muffins with 35% (C1) or 40% (C2) RBF for 10 weeks. Sensory evaluation showed high acceptability of the 35% RBF muffins, comparable to control muffins. Clinical outcomes indicated that both intervention groups experienced improvements in body weight, BMI, blood pressure, liver enzymes, and lipid profiles, with more pronounced benefits observed in the 40% RBF group. The findings suggest that RBF-enriched muffins, particularly at 40% substitution, can offer functional, nutritional, and clinical benefits for individuals with hypertension.
Detailed description
- Materials and Methods The study received ethical approval from the University of Lahore (REC-UOL/466/08/24). Informed consent was obtained from all participants, who were fully informed about the study's aims, methods, risks, and benefits, and were allowed to ask questions and withdraw at any time.
2.2. Materials Raw banana flour, whole wheat flour, brown sugar, baking powder, pink salt, coconut oil, vanilla essence, cinnamon powder, eggs, and plastic bags were procured from the local market of Lahore, Pakistan, and subsequently stored in the Food Science and Nutrition Lab at the University Institute of Diet and Nutritional Sciences (UIDNS), University of Lahore, Pakistan. Standard kits from Merck Specialities Pvt. Ltd. were employed to assess liver enzyme tests and lipid profiles.
2.3. Settings: This study took place at the Food Science and Nutrition Lab, UIDNS, University of Lahore, and Nutrition Department, Noor Hospital Lahore, Lahore, Pakistan.
2.4. Sensory Evaluation Muffins were tasted by 10 professionals. Randomly placed muffins have two-digit codes. Cookies with two-digit numbers were distributed randomly. The panelists used a 9-point hedonic scale (9 = highly liked; 1 = severely disliked) to rate color, appearance, flavor, texture, overall acceptability, and affordability (Wichchukit \& O'Mahony, 2015). During sensory evaluation, panelists cleaned their taste receptors with mineral water and expectorant cups (Handa et al., 2012).
2.5. Subjects In this pilot study, 48 patients signed up; however, 6 of them were not allowed to participate because they did not meet the requirements (Figure 1). We randomly put 42 patients into three groups. There were three groups of 42 patients, each with the same number of people. There were 14 people in each group. Four people were left out of the control group (C0) because of some personal issues. Two people were taken out of the intervention group (C1) because they had to travel, were constipated, or started using an alternative medicine. Two other people moved from the intervention group (C2) to start taking an alternative medicine. Figure 1 shows that 10 patients were in the control group, 12 were in the intervention group (C1), and 12 were in the other intervention group (C2). All of them finished the trial and were tested after 10 weeks, lipid profile and liver enzymes were assessed at the end of study.
2.6 2.9. Statistical analysis All sensory evaluation data were expressed as mean ± standard deviation (SD). One-way analysis of variance (ANOVA) was performed to determine significant differences among the control and raw banana flour-enriched muffin sample groups for each sensory attribute (Steel \& Torrie, 1981).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF)Patients received Whole wheat muffin |
| 17.5g RBF Group | Experimental | Dietary Supplement: Whole wheat muffinWhole wheat muffin enriched with raw banana flower (RBF) (contains 17.5g RBF) |
| 20 g RBF Group | Experimental | Dietary Supplement: Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF)Whole wheat muffin enriched with raw banana flower (RBF) (contains 20g RBF) |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The study included men and women between the ages of 35 and 55.
- who had high levels of total cholesterol (>220 mg/dL), total triglycerides (>150 mg/dL), and low-density lipoprotein (>130 mg/dL).
Key exclusion criteria (2 listed)
- People with diabetes, serious diseases, or surgeries in the last three months, or other conditions that might produce high cholesterol, were not allowed to take part.
- People who had gastrointestinal problems or were known to be allergic to cinnamon were also not accepted.
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 |
|---|---|---|
| Whole wheat muffinParticipants received Whole wheat muffin once a day | Dietary supplement | 17.5g RBF Group |
| Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF)Participants received Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF) | Dietary supplement | 20 g RBF Group |
| Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF)Participants received Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF) | Dietary supplement | Placebo group |
Primary outcome
Lipid Profile
Time frame: 10 Weeks
Level of total cholesterol (mg/dL), total triglycerides (mg/dL), and low-density lipoprotein (mg/dL) were measure.
Blood Pressure (systolic pressure and diastolic pressure)
Time frame: 10 Weeks
Level of Blood pressure was observed among hypertensive patients
1 secondary outcome
Liver Enzymes
Time frame: 10 weeks
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 5 Sep 2025.
- Results publication: PubMed 32033343Amini Khoozani A, Kebede B, Birch J, Bekhit AEA. The Effect of Bread Fortification with Whole Green Banana Flour on Its Physicochemical, Nutritional and In Vitro Digestibility. Foods. 2020 Feb 5;9(2):152. doi: 10.3390/foods9020152.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole wheat muffin, Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF) and Whole wheat muffin enriched with raw banana flour (RBF) (contains 20g RBF) in people with Hypertension (HTN) and Lipid Profile, 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 2 inclusion and 2 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 5 Sep 2025. 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?
Lipid Profile (time frame: 10 Weeks). The study lists 2 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 NCT07145710, 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 5 Sep 2025.