Clinical trial NCT05786534: Therapeutic Effect of Green Seaweed Against Metabloc Syndrome
Official title: Therapeutic Potential of Green Seaweed, Ulva Lactuca, Against Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Hypertension
Diabetes
Obesity
Dyslipidemia
Seaweed
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case Control Study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Blood pressure will be assessed before and after the trial
timeFrame: 40 days
measure: Lipid profile will be assessed before and after the trial
timeFrame: 40 days
measure: Fasting glucose level will be assessed before and after the trial
timeFrame: 40 days
measure: Weight will be measured before and after the trial
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrānwāla
country: Pakistan
facility: Ashraf Hospital
state: Punjab
Study officials:
References:
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.