Effect of Mulberry Fruit Powder in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Therapeutic Effect of Mulberry Fruit Powder Consumption in Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956106
• Other study ID #: Mulberry Fruit Powder
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2023
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: Fiza Maqbool, DNS
• Phone: 03008077414
• Email: fizach65[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Black Mulberry Fruit Powder
Anthocyanin plays a major role in preventing symptoms of metabolic syndrome.

Locations

Country	Name	City	State
Pakistan	Shan Medicare Hospital	Arifwala	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Veterinary and Animal Sciences, Lahore - Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Wan M, Li Q, Lei Q, Zhou D, Wang S. Polyphenols and Polysaccharides from Morus alba L. Fruit Attenuate High-Fat Diet-Induced Metabolic Syndrome Modifying the Gut Microbiota and Metabolite Profile. Foods. 2022 Jun 20;11(12):1818. doi: 10.3390/foods11121818 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid profile will be assessed before and after the trial.	The change in lipid profile, after consuming mulberry fruit powder for 45 days, will be assessed. The value will be closed to optimized values.	45 days
Primary	Fasting glucose level will be assessed before and after the trial	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	45 days
Primary	Weight circumference will be measured before and after the trial	The change in weight will be measured after consuming mulberry fruit powder for 45 days.The value will be close to normal range.	45 days
Primary	Blood pressure will be assessed before and after the trial.	The change in systolic and diastolic blood pressure, after consuming mulberry fruit powder for 45 days. The values will become close to optimized levels.	45 days

External Links

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