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
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Condition or disease | Intervention/treatment | Phase |
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Metabolic Syndrome | Dietary Supplement: Black Mulberry Fruit Powder | Not Applicable |
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 (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 |
Arm | Intervention/treatment |
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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
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Dietary Supplement: Black Mulberry Fruit Powder
Anthocyanin plays a major role in preventing symptoms of metabolic syndrome.
Other Name: Morus Nigra |
- 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.
- 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
- 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.
- 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.
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Ages Eligible for Study: | 35 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Fiza Maqbool, DNS | 03008077414 | fizach65@gmail.com |
Pakistan | |
Shan Medicare Hospital | Recruiting |
Arifwala, Punjab, Pakistan, 57450 | |
Contact: Dr. Muhammad Illyas, FCPS +923075055198 |
Publications of Results:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Diabetes Obesity |
Hyperlipidemia Mulberry Anthocyanin |
Metabolic Syndrome Syndrome Disease Pathologic Processes |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |