Clinical trial NCT05956106: Effect of Mulberry Fruit Powder in Metabolic Syndrome
Official title: Therapeutic Effect of Mulberry Fruit Powder Consumption in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Hypertension
Diabetes
Obesity
Hyperlipidemia
Mulberry
Anthocyanin
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case-Control Study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Lipid profile will be assessed before and after the trial.
timeFrame: 45 days
measure: Fasting glucose level will be assessed before and after the trial
timeFrame: 45 days
measure: Weight circumference will be measured before and after the trial
timeFrame: 45 days
measure: Blood pressure will be assessed before and after the trial.
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Arifwala
country: Pakistan
facility: Shan Medicare Hospital
state: Punjab
Study officials:
References:
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.