Raw Banana Flour-Enriched Muffins for Hypertensive Patients

NCT07145710 | Completed DMC

• 1 other identifier: REC-UOL/466/08/24
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension (HTN); Lipid Profile; Liver Enzymes

Keywords

Hypertension; dietary fiber; bioactive compounds; cardiovascular health; functional food; intervention, muffins

Outcome Measures

Primary Outcomes (2)

• Lipid Profile

  Level of total cholesterol (mg/dL), total triglycerides (mg/dL), and low-density lipoprotein (mg/dL) were measure.

  10 Weeks

• Blood Pressure (systolic pressure and diastolic pressure)

  Level of Blood pressure was observed among hypertensive patients

  10 Weeks

Secondary Outcomes (1)

• Liver Enzymes

  10 weeks

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Patients received Whole wheat muffin

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)

Dietary Supplement: Whole wheat muffin

20 g RBF Group

EXPERIMENTAL

Whole wheat muffin enriched with raw banana flower (RBF) (contains 20g RBF)

Dietary Supplement: Whole wheat muffin enriched with raw banana flour (RBF) (contains 17.5g RBF)

Interventions

Whole wheat muffin DIETARY_SUPPLEMENT

Participants received Whole wheat muffin once a day

17.5g RBF Group

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)

20 g RBF Group

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)

Placebo group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Sana Noreen

Lahore, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 32033343 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: August 8, 2024
• Primary Completion: October 18, 2024
• Study Completion: October 20, 2024
• Last Updated: September 5, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)