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Effect of Mulberry Fruit Powder in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Black Mulberry Fruit Powder
Sponsored by
University of Veterinary and Animal Sciences, Lahore - Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring Hypertension, Diabetes, Obesity, Hyperlipidemia, Mulberry, Anthocyanin

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • THQ HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metabolic syndrome patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2023
Last Updated
October 23, 2023
Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05956106
Brief Title
Effect of Mulberry Fruit Powder in Metabolic Syndrome
Official Title
Therapeutic Effect of Mulberry Fruit Powder Consumption in Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Hypertension, Diabetes, Obesity, Hyperlipidemia, Mulberry, Anthocyanin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case-Control Study
Masking
None (Open Label)
Masking Description
Participants groups
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metabolic syndrome patients
Arm Type
Experimental
Arm Description
Dried Mulberry fruit powder is used for preventing symptoms in Metabolic Syndrome patients Dietary intervention: Black Mulberry fruit powder Dosage: 45g per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Black Mulberry Fruit Powder
Other Intervention Name(s)
Morus Nigra
Intervention Description
Anthocyanin plays a major role in preventing symptoms of metabolic syndrome.
Primary Outcome Measure Information:
Title
Lipid profile will be assessed before and after the trial.
Description
The change in lipid profile, after consuming mulberry fruit powder for 45 days, will be assessed. The value will be closed to optimized values.
Time Frame
45 days
Title
Fasting glucose level will be assessed before and after the trial
Description
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
Time Frame
45 days
Title
Weight circumference will be measured before and after the trial
Description
The change in weight will be measured after consuming mulberry fruit powder for 45 days.The value will be close to normal range.
Time Frame
45 days
Title
Blood pressure will be assessed before and after the trial.
Description
The change in systolic and diastolic blood pressure, after consuming mulberry fruit powder for 45 days. The values will become close to optimized levels.
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fiza Maqbool, DNS
Phone
03008077414
Email
fizach65@gmail.com
Facility Information:
Facility Name
THQ Hospital
City
Arifwala
State/Province
Punjab
ZIP/Postal Code
57450
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Rauf Alvi, FCPS
Phone
+92457-830100

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All available data will be confidential
Citations:
PubMed Identifier
35742014
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35742014/
Description
Polyphenols and Polysaccharides from Morus alba L. Fruit Attenuate High-Fat Diet-Induced Metabolic Syndrome

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Effect of Mulberry Fruit Powder in Metabolic Syndrome

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