Metabolic SyndromeNCT05786534
Therapeutic Effect of Green Seaweed Against Metabloc Syndrome
A study testing Green Seaweed in people with Metabolic Syndrome, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Green Seaweed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Dec 2022to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 25kg/m2
- Dyslipidemia
- Altered blood glucose level
- Age 30-55 ( male and female)
Who cannot join
- Thyroid disorder
- Liver disease
- Kidney disorder
- Cancer etc
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ashraf Hospital
Chak One Hundred Seventy-five Nine Left, Punjab Province, 52250
About this study
Official title: Therapeutic Potential of Green Seaweed, Ulva Lactuca, Against Metabolic Syndrome
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Green Seaweed
- Keywords
- Metabolic Syndrome, Hypertension, Diabetes, Obesity, Dyslipidemia, Seaweed
- Medical subject headings
- Metabolic Syndrome, Hypertension, Diabetes Mellitus, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green SeaweedDietary supplement
Also called Ulva Lactuca
400 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Syndrome patients | Experimental | Green seaweed Ulva Lactuca is used for preventing symptoms in Metabolic Syndrome patients Receives: Dietary Supplement: Green Seaweed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start9 Dec 2022
- Primary completion10 Nov 2023 (estimated)
- Study completion10 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case Control Study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asif Ali, University of Veterinary and Animal Sciences, Lahore - Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786534
- Sponsor's protocol ID
- Green Seaweed
- Status last verified
- Sep 2023
- First submitted
- 3 Mar 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All available data will be confidential
Publications
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.
PubMed 26569268
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Potential of Green Seaweed, Ulva Lactuca, Against Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05786534
- Acronym / sponsor ID
- Green Seaweed
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Hypertension, Diabetes, Obesity, Dyslipidemia, Seaweed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 10 Nov 2023 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case Control Study
| Arm | Type | Receives |
|---|---|---|
| Metabolic Syndrome patients | Experimental | Dietary Supplement: Green SeaweedGreen seaweed Ulva Lactuca is used for preventing symptoms in Metabolic Syndrome patients |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI > 25kg/m2
- Dyslipidemia
- Altered blood glucose level
- Age 30-55 ( male and female)
Key exclusion criteria (4 listed)
- Thyroid disorder
- Liver disease
- Kidney disorder
- Cancer etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green SeaweedAlso: Ulva Lactuca400 mg per day | Dietary supplement | Metabolic Syndrome patients |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Results publication: PubMed 26569268Cardoso 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.
- Seaweeds as Preventive Agents for Cardiovascular DiseasesLink provided by the sponsor.
- Individual participant dataSharing planned: No. All available data will be confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Seaweed in people with Metabolic Syndrome, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure will be assessed before and after the trial (time frame: 40 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05786534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.