Therapeutic Effect of Green Seaweed Against Metabloc Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Therapeutic Potential of Green Seaweed, Ulva Lactuca, Against Metabolic Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05786534
• Other study ID #: Green Seaweed
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: September 2023
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Green Seaweed
400 mg per day

Locations

Country	Name	City	State
Pakistan	Ashraf Hospital	Gujranwala	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Veterinary and Animal Sciences, Lahore - Pakistan

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Seaweeds as Preventive Agents for Cardiovascular Diseases