Effect of Mulberry Fruit Powder in Metabolic Syndrome

Sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05956106

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Metabolic syndrome is a raising concern globally, especially in developing countries such as Pakistan. To prevent its risk factors diet and lifestyle modification is major solution. Functional foods have additional benefits of treating disease while providing basic nutrients. Mulberry is a native fruit with the properties of functional food, it is rich in anthocyanin and different anti-obesity,anti-diabetic, and anti-hyperlipidemic treating potential antioxidants. Mulberry will prove its therapeutic potential against the risk factors of metabolic syndrome.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Dietary Supplement: Black Mulberry Fruit Powder	N/A

Detailed Description

Metabolic syndrome, which is characterized by a number of concurrent risk factors. These risk factors include dysglycemia, high blood pressure, high triglyceride levels, low levels of HDL cholesterol, and obesity (particularly central adiposity). It is rapidly increasing the burden of non-communicable diseases (NCDs) in Pakistan. The prevalence of MetS in Pakistan is 28.6%, and suburban areas from the province of Punjab showed a high prevalence. Females are more prone to metabolic syndrome. Dietary and lifestyle modification can prevent MetS from converting into CVD, T2DM, and stroke. There is limited documented research in Pakistan related to the therapeutic roles of mulberry fruit powder. With respect to these limitations, the present study aims to assess the therapeutic roles of mulberry fruit powder consumption on metabolic syndrome.

Hypothesis:

The utilization of dried mulberry fruit powder (MFP) as a component of nutritional supplementation will effectively ameliorate the clinical markers associated with metabolic syndrome.

Methodology:

In this randomized control trial, raw material will be collected from a local fruit shop in Lahore, and after shade drying, it will be made into edible powder. Proximate and antioxidant analysis of MFP will be carried out by standard AOAC and pH differential methods respectively in Nutrition Lab; FSHN. Participants will be screened for the risk factors of MetS, sixty participants will be recruited by following the purposive sampling method from a permitted hospital. For interventional group participants, a 45g dose of MFP with a balanced diet will be given each day for 6 weeks whereas the control group will be on a normal diet with no MFP intake. Biochemical analysis for total lipid profile and glucose will be performed before and after the intervention to evaluate the difference in mean values. Pre and post-intervention readings of waist circumference, as well as systolic blood pressure, will also be recorded.

Statistical Analysis:

Descriptive stats will be used to analyze demographics. Paired sample t-test will be applied to compare the difference between all lab values. Chi-square will be performed to analyze the difference in anthropometric measurements.

Expected Outcomes:

Improvement in total lipid profile
Improvement in fasting blood glucose
Reduction in anthropometrics measurements
Reduction in systolic blood pressure

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Case-Control StudyCase-Control Study

Masking:

None (Open Label)

Masking Description:

Participants groups

Primary Purpose:

Supportive Care

Official Title:

Therapeutic Effect of Mulberry Fruit Powder Consumption in Metabolic Syndrome

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metabolic syndrome patients Dried Mulberry fruit powder is used for preventing symptoms in Metabolic Syndrome patients Dietary intervention: Black Mulberry fruit powder Dosage: 45g per day	Dietary Supplement: Black Mulberry Fruit Powder Anthocyanin plays a major role in preventing symptoms of metabolic syndrome. Other Names: Morus Nigra

Arm

Intervention/Treatment

Experimental: Metabolic syndrome patients

Dried Mulberry fruit powder is used for preventing symptoms in Metabolic Syndrome patients Dietary intervention: Black Mulberry fruit powder Dosage: 45g per day

Dietary Supplement: Black Mulberry Fruit Powder

Anthocyanin plays a major role in preventing symptoms of metabolic syndrome.

Other Names:

Morus Nigra

Outcome Measures

Primary Outcome Measures

Lipid profile will be assessed before and after the trial. [45 days]
The improvement in lipid profile, after consuming mulberry fruit powder for 45 days, will be assessed. The value will be closed to optimized values.
Fasting glucose level will be assessed before and after the trial [45 days]
The change in fasting glucose levels will be assessed after consuming mulberry fruit powder for 45 days.The values will be become close to optimized levels
Weight circumference will be measured before and after the trial [45 days]
The change in weight will be measured after consuming mulberry fruit powder for 45 days.The value will be close to normal range.
Blood pressure will be assessed before and after the trial. [45 days]
The change in blood pressure, after consuming mulberry fruit powder for 45 days. The values will become close to optimized levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects having fasting total cholesterol level of ≥ 200 mg/dl or LDL cholesterol ≥ 130 mg/dl.
Fasting Blood Glucose ≥110mg/dl.
SBP ≥ 130/ ≥ 85 mmHg
Waist Circumference of ≥40 inches in males and ≥35 inches for females

Exclusion Criteria:

Participants of age 55 or above
Participants who have less than two risk factors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	THQ Hospital	Arifwala	Punjab	Pakistan	57450

Sponsors and Collaborators

University of Veterinary and Animal Sciences, Lahore - Pakistan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Polyphenols and Polysaccharides from Morus alba L. Fruit Attenuate High-Fat Diet-Induced Metabolic Syndrome

Publications

None provided.

Responsible Party:

Asif Ali, Lecturer, Department of Food Sciences and Human Nutrition, University of Veterinary and Animal Sciences, Lahore - Pakistan

ClinicalTrials.gov Identifier:

NCT05956106

Other Study ID Numbers:

Mulberry Fruit Powder

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Asif Ali, Lecturer, Department of Food Sciences and Human Nutrition, University of Veterinary and Animal Sciences, Lahore - Pakistan

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Jul 21, 2023