NCT05786534

Brief Summary

Metabolic syndrome is a major concern worldwide and in Pakistan as well. Metabolic syndrome is a pathologic condition which includes abdominal obesity, insulin resistance, hypertension and hyperlipidemia. Seafood consumption has been linked to reduced risk of many health conditions including altered blood profile. Green seaweed is known to have a potential in optimizing the blood profile and so, it is helpful in reducing the risk of metabolic syndrome by playing a role in preventing obesity, hyperglycemia, high blood pressure and altered lipid profile. Green seaweed (Ulva Lactuca) powder will prove to have therapeutic potential against obesity, hypertension, glucose intolerance and dyslipidemia.

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 Dec 2022

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

Study Start

First participant enrolled

December 9, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

March 3, 2023

Last Update Submit

September 28, 2023

Conditions

Metabolic Syndrome

Keywords

Metabolic SyndromeHypertensionDiabetesObesityDyslipidemiaSeaweed

Outcome Measures

Primary Outcomes (4)

  • Blood pressure will be assessed before and after the trial

    The change in blood pressure, after consuming green seaweed powder for 40 days, will be assessed. The values will become close to optimized levels.

    40 days

  • Lipid profile will be assessed before and after the trial

    The improvement in lipid profile, after consuming green seaweed powder for 40 days, will be assessed. The values will become close to optimized values.

    40 days

  • Fasting glucose level will be assessed before and after the trial

    The change in fasting glucose levels will be assessed, after consuming green seaweed powder for 40 days. The values will become close to optimized levels.

    40 days

  • Weight will be measured before and after the trial

    The change in weight will be measured, after consuming green seaweed powder for 40 days. BMI will become close to normal range.

    40 days

Study Arms (1)

Metabolic Syndrome patients

EXPERIMENTAL

Green seaweed Ulva Lactuca is used for preventing symptoms in Metabolic Syndrome patients

Dietary Supplement: Green Seaweed

Interventions

Green SeaweedDIETARY_SUPPLEMENT

400 mg per day

Also known as: Ulva Lactuca
Metabolic Syndrome patients

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 25kg/m2
  • Dyslipidemia
  • Altered blood glucose level
  • Age 30-55 ( male and female)

You may not qualify if:

  • Thyroid disorder
  • Liver disease
  • Kidney disorder
  • Cancer etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashraf Hospital

Gujranwala, Punjab Province, 52250, Pakistan

Location

Related Publications (1)

  • Cardoso SM, Pereira OR, Seca AM, Pinto DC, Silva AM. Seaweeds as Preventive Agents for Cardiovascular Diseases: From Nutrients to Functional Foods. Mar Drugs. 2015 Nov 12;13(11):6838-65. doi: 10.3390/md13116838.

    PMID: 26569268RESULT

Related Links

MeSH Terms

Conditions

Metabolic SyndromeHypertensionDiabetes MellitusObesityDyslipidemias

Condition Hierarchy (Ancestors)

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

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
Researcher

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 27, 2023

Study Start

December 9, 2022

Primary Completion

November 10, 2023

Study Completion

November 10, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

All available data will be confidential

Locations

PA(1)