NCT05956106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

July 13, 2023

Last Update Submit

November 2, 2023

Conditions

Metabolic Syndrome

Keywords

HypertensionDiabetesObesityHyperlipidemiaMulberryAnthocyanin

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

Study Arms (1)

Metabolic syndrome patients

EXPERIMENTAL

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

Interventions

Black Mulberry Fruit PowderDIETARY_SUPPLEMENT

Anthocyanin plays a major role in preventing symptoms of metabolic syndrome.

Also known as: Morus Nigra
Metabolic syndrome patients

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Participants of age 55 or above
  • Participants who have less than two risk factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shan Medicare Hospital

Arifwala, Punjab Province, 57450, Pakistan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35742014RESULT

Related Links

MeSH Terms

Conditions

Metabolic SyndromeHypertensionDiabetes MellitusObesityHyperlipidemias

Interventions

morniga G protein, Morus nigra

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism Disorders

Central Study Contacts

Fiza Maqbool, DNS

CONTACT

03008077414fizach65@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants groups
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Case-Control Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Food Sciences and Human Nutrition

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

August 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 3, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

All available data will be confidential

Locations

PA(1)