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Therapeutic Effect of Green Seaweed Against Metabloc Syndrome

Primary Purpose

Metabolic Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Green Seaweed
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 Metabolic Syndrome, Hypertension, Diabetes, Obesity, Dyslipidemia, Seaweed

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: BMI > 25kg/m2 Dyslipidemia Altered blood glucose level Age 30-55 ( male and female) Exclusion Criteria: Thyroid disorder Liver disease Kidney disorder Cancer etc

Sites / Locations

  • Ashraf Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metabolic Syndrome patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2023
Last Updated
September 28, 2023
Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05786534
Brief Title
Therapeutic Effect of Green Seaweed Against Metabloc Syndrome
Official Title
Therapeutic Potential of Green Seaweed, Ulva Lactuca, Against Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 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 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.
Detailed Description
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. Statement of problem: The number of people with high LDL-cholesterol, body mass index and fasting plasma glucose levels has been increasing. These factors are promoting the risk of metabolic syndrome in Pakistan. 26-38% people in Pakistan are reported to be a patient of metabolic syndrome. Seaweed has shown to be protective against the syndrome in previous studies. The goal of this study is to check the role of green seaweed against metabolic syndrome. Hypothesis: Green seaweed (Ulva Lactuca) has a potential to manage metabolic syndrome. Objective: To assess the therapeutic effect of green seaweed (Ulva Lactuca) against metabolic syndrome. Methodology: Green seaweed powder will be procured from Taokaenoi Food and Marketing Public Co., Ltd. (Thailand). The proximate analysis of the product will be performed and then capsules of powder will be prepared to be consumed by the participants. Total 40 subjects (20 in treatment group and 20 in control group) will be selected and green seaweed powder will be added in their diets (200mg twice a day). After a trial of 40 days, the patients will be assessed. Assessment will include anthropometric measurements, blood pressure, lipid profile analysis and total antioxidant capacity (TAC) which will be monitored before and after the trial and final,ly, the data collected will be analyzed by using SPSS 25 by paired sample t test. P value ≤ 0.05 will be considered significant. Expected outcomes: Green seaweed (Ulva Lactuca) powder will prove to have therapeutic potential against obesity, hypertension, glucose intolerance and dyslipidemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, Hypertension, Diabetes, Obesity, Dyslipidemia, Seaweed

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
Green seaweed Ulva Lactuca is used for preventing symptoms in Metabolic Syndrome patients
Intervention Type
Dietary Supplement
Intervention Name(s)
Green Seaweed
Other Intervention Name(s)
Ulva Lactuca
Intervention Description
400 mg per day
Primary Outcome Measure Information:
Title
Blood pressure will be assessed before and after the trial
Description
The change in blood pressure, after consuming green seaweed powder for 40 days, will be assessed. The values will become close to optimized levels.
Time Frame
40 days
Title
Lipid profile will be assessed before and after the trial
Description
The improvement in lipid profile, after consuming green seaweed powder for 40 days, will be assessed. The values will become close to optimized values.
Time Frame
40 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 green seaweed powder for 40 days. The values will become close to optimized levels.
Time Frame
40 days
Title
Weight will be measured before and after the trial
Description
The change in weight will be measured, after consuming green seaweed powder for 40 days. BMI will become close to normal range.
Time Frame
40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 25kg/m2 Dyslipidemia Altered blood glucose level Age 30-55 ( male and female) Exclusion Criteria: Thyroid disorder Liver disease Kidney disorder Cancer etc
Facility Information:
Facility Name
Ashraf Hospital
City
Gujrānwāla
State/Province
Punjab
ZIP/Postal Code
52250
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All available data will be confidential
Citations:
PubMed Identifier
26569268
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/26569268/
Description
Seaweeds as Preventive Agents for Cardiovascular Diseases

Learn more about this trial

Therapeutic Effect of Green Seaweed Against Metabloc Syndrome

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