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Effect of Mulberry Fruit Powder in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT05956106
Recruitment Status : Recruiting
First Posted : July 21, 2023
Last Update Posted : November 3, 2023
Sponsor:
Information provided by (Responsible Party):
Asif Ali, University of Veterinary and Animal Sciences, Lahore - Pakistan

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Case-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
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Morus Nigra


Outcome Measures
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Primary Outcome Measures :
  1. Lipid profile will be assessed before and after the trial. [ Time Frame: 45 days ]
    The change in lipid profile, after consuming mulberry fruit powder for 45 days, will be assessed. The value will be closed to optimized values.

  2. Fasting glucose level will be assessed before and after the trial [ Time Frame: 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

  3. Weight circumference will be measured before and after the trial [ Time Frame: 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.

  4. Blood pressure will be assessed before and after the trial. [ Time Frame: 45 days ]
    The change in systolic and diastolic blood pressure, after consuming mulberry fruit powder for 45 days. The values will become close to optimized levels.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05956106


Contacts
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Contact: Fiza Maqbool, DNS 03008077414 fizach65@gmail.com

Locations
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Pakistan
Shan Medicare Hospital Recruiting
Arifwala, Punjab, Pakistan, 57450
Contact: Dr. Muhammad Illyas, FCPS    +923075055198      
Sponsors and Collaborators
University of Veterinary and Animal Sciences, Lahore - Pakistan
More Information
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Additional Information:

Publications of Results:

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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: July 21, 2023    Key Record Dates
Last Update Posted: November 3, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All available data will be confidential

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asif Ali, University of Veterinary and Animal Sciences, Lahore - Pakistan:
Hypertension
Diabetes
Obesity
 Hyperlipidemia
Mulberry
Anthocyanin
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases