Effect of Mulberry Fruit Powder in Metabolic Syndrome

Therapeutic Effect of Mulberry Fruit Powder Consumption in Metabolic Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Black Mulberry Fruit Powder

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.

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fiza Maqbool, DNS; Phone Number: 03008077414; Email: fizach65@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Arifwala, Punjab, Pakistan, 57450
      • Recruiting
      • Shan Medicare Hospital
      • Contact: Dr. Muhammad Illyas, FCPS; Phone Number: +923075055198

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Obesity; Hypertension; Hyperlipidemia; Mulberry; Anthocyanin
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: Mulberry Fruit Powder

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All available data will be confidential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No