- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05786534
Therapeutic Effect of Green Seaweed Against Metabloc Syndrome
Therapeutic Potential of Green Seaweed, Ulva Lactuca, Against Metabolic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Gujrānwāla, Punjab, Pakistan, 52250
- Ashraf Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metabolic Syndrome patients
Green seaweed Ulva Lactuca is used for preventing symptoms in Metabolic Syndrome patients
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400 mg per day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure will be assessed before and after the trial
Time Frame: 40 days
|
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
Time Frame: 40 days
|
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
Time Frame: 40 days
|
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
Time Frame: 40 days
|
The change in weight will be measured, after consuming green seaweed powder for 40 days.
BMI will become close to normal range.
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40 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Green Seaweed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Universidad de los Andes, ChileCompleted
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-
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Cairo UniversityCompletedMetabolic Syndrome in WomenEgypt
-
Andalas UniversityHasanuddin University; Universitas Sumatera UtaraCompletedMetabolic Syndrome, Protection AgainstIndonesia
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-
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