Metabolic SyndromeNCT03853343
Seaweed Extract Supplementation and Metabolic Biomarkers
A study testing Seaweed extract in people with Metabolic Syndrome and Insulin Sensitivity, run by BioAtlantis Ltd. at 1 site in United Kingdom.
Trial summary
Double blinded, randomized, placebo controlled preliminary pilot exploratory investigation into the effects of brown seaweed extract supplementation, on fasting blood Insulin, fasting blood glucose, insulin sensitivity, blood inflammatory markers and tolerance in healthy overweight adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Insulin Sensitivity
- What is being tested?
- Seaweed extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2018to 30 Jan 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) 25-35 kg/m2
- Not dieting within the last month and not having lost >5% body weight in the previous year
- Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
- Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice
- Able to eat most everyday foods
- Habitually consumes three standard meals a day
Who cannot join
- Significant health problems (e.g. hypercholesterolaemia, diabetes, GI disorders)
- Taking any medication or supplements known to affect mineral or glucose metabolism within the past month and/or during the study
- Pregnant, planning to become pregnant or breastfeeding
- History of anaphylaxis to food
- Known allergies or intolerance to foods and/or to the study materials (or closely related compounds) or any of their stated ingredients
- BMI <25 kg/m2 or >35 kg/m2
Show all 13Show fewer
- Volunteers self-reporting currently dieting or having lost >5% body weight in the previous year
- Participants with abnormal eating behaviour
- Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit
- Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change them during the study
- Participants receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
- Participants on specific food avoidance diets
- Participants who work in appetite or feeding related areas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Exploratory Investigation Into the Effects of Brown Seaweed Extract Supplementation on Metabolic Biomarkers
Double blinded, randomized, placebo controlled preliminary pilot exploratory investigation into the effects of brown seaweed extract supplementation, on fasting blood Insulin, fasting blood glucose, insulin sensitivity, blood inflammatory markers and tolerance in healthy overweight adults.
Read the detailed description
Diabetes melitus is a group of metabolic disorders resulting from a defect in insulin production and/or insulin action. The World Health Organisation (WHO) has estimated that the total number of people with diabetes mellitus worldwide will increase from 171 million in 2000 to nearly 370 million in 2030 with the prevalence of the disease for all age groups to be 4.4%. 90% of diabetes cases worldwide are of Type II diabetes mellitus (T2DM) as a result of greater prevalence of sedentary lifestyle, unhealthy diet and rise of obesity, as well as an increasing number of elderly population. T2DM can be attributed to relative deficiency of insulin, involving insulin resistance, aberrant synthesis of hepatic glucose and progressive deterioration of pancreatic beta-cell functions resulting in chronic hyperglycaemia with disturbances in carbohydrate, fat and protein metabolism. Insulin resistance, classically defined as a decreased sensitivity to metabolic actions of insulin, is recognised as an important risk factor in the pathogenesis of various disorders, including T2DM. However, insulin resistance and ß-cell dysfunction can be asymptomatic and may remain undiagnosed for many years. Current T2DM management employs a range of pharmacological (hypoglycaemic agents) and lifestyle (diet, exercise) intervention approaches aiming at managing hyperglycaemia, with the main objective being to ensure sufficient delivery of glucose to the various tissues of the body and prevent hyperglycaemia by achieving good glycemic control. Nutrition has been regarded to play a significant role in the complex pathophysiology of T2DM and in the last several years, increasing amount of evidence has emerged linking various nutrients and food sources with a positive management of T2DM.
Seaweed have traditionally been consumed as a readily available whole food or traditional medical preparations, especially in Asia. Seaweeds are rich in bioactive compounds in the form of polyphenols, carotenoids, vitamins, minerals, phycobilins, phycocyanins, and polysaccharides, many of which are known to offer a wide range of benefits in human health.
- Conditions
- Metabolic Syndrome, Insulin Sensitivity
- Being tested
- Seaweed extract, Placebo
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seaweed extractDietary supplement
1 capsule 3 times per day
PlaceboDietary supplement
1 capsule 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3 capsules per day (1 before each meal) of cellulose Receives: Dietary Supplement: Placebo |
| Seaweed extract | Active comparator | 3 capsules per day (1 before each meal) of seaweed extract Receives: Dietary Supplement: Seaweed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Glucose concentration
Changes in plasma glucose in healthy volunteers with BMI>25 after 3 weeks of treatment
Measured: 3 weeks
Change of Plasma Insulin concentration
Changes in plasma insulin in healthy volunteers with BMI>25 after 3 weeks of treatment
Measured: 3 weeks
Change in metabolic parameters
Changes in insulin sensitivity based on Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) test
Measured: 3 weeks
Secondary outcomes (2)
Change in Blood Lipids
Changes in total cholesterol, HDL-C and triglycerides following 3 weeks supplementation
Measured: 3 weeks
Change in plasma Markers of inflammation
Changes in Tumor Necrosis Factor-alpha, Interleukin-6, Interleukin-1b, Interleukin-10, Interferon-gamma and C-Reactive Protein following 3 weeks of supplementation
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start28 Jun 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAtlantis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Roehampton
- Responsible party
- Principal investigator, Dr. George Tzortzis, BioAtlantis Ltd.
- Investigators
- George Tzortzis, Study director, BioAtlantis Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853343
- Sponsor's protocol ID
- BioAtlDG001
- Status last verified
- Mar 2022
- First submitted
- 22 Jan 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Exploratory Investigation Into the Effects of Brown Seaweed Extract Supplementation on Metabolic Biomarkers
- ClinicalTrials.gov ID
- NCT03853343
- Acronym / sponsor ID
- BioAtlDG001
- Conditions
- Metabolic Syndrome, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BioAtlantis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Roehampton
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 25 Feb 2019 (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.
Double blinded, randomized, placebo controlled preliminary pilot exploratory investigation into the effects of brown seaweed extract supplementation, on fasting blood Insulin, fasting blood glucose, insulin sensitivity, blood inflammatory markers and tolerance in healthy overweight adults.
Detailed description
Diabetes melitus is a group of metabolic disorders resulting from a defect in insulin production and/or insulin action. The World Health Organisation (WHO) has estimated that the total number of people with diabetes mellitus worldwide will increase from 171 million in 2000 to nearly 370 million in 2030 with the prevalence of the disease for all age groups to be 4.4%. 90% of diabetes cases worldwide are of Type II diabetes mellitus (T2DM) as a result of greater prevalence of sedentary lifestyle, unhealthy diet and rise of obesity, as well as an increasing number of elderly population. T2DM can be attributed to relative deficiency of insulin, involving insulin resistance, aberrant synthesis of hepatic glucose and progressive deterioration of pancreatic beta-cell functions resulting in chronic hyperglycaemia with disturbances in carbohydrate, fat and protein metabolism. Insulin resistance, classically defined as a decreased sensitivity to metabolic actions of insulin, is recognised as an important risk factor in the pathogenesis of various disorders, including T2DM. However, insulin resistance and ß-cell dysfunction can be asymptomatic and may remain undiagnosed for many years. Current T2DM management employs a range of pharmacological (hypoglycaemic agents) and lifestyle (diet, exercise) intervention approaches aiming at managing hyperglycaemia, with the main objective being to ensure sufficient delivery of glucose to the various tissues of the body and prevent hyperglycaemia by achieving good glycemic control. Nutrition has been regarded to play a significant role in the complex pathophysiology of T2DM and in the last several years, increasing amount of evidence has emerged linking various nutrients and food sources with a positive management of T2DM.
Seaweed have traditionally been consumed as a readily available whole food or traditional medical preparations, especially in Asia. Seaweeds are rich in bioactive compounds in the form of polyphenols, carotenoids, vitamins, minerals, phycobilins, phycocyanins, and polysaccharides, many of which are known to offer a wide range of benefits in human health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo3 capsules per day (1 before each meal) of cellulose |
| Seaweed extract | Active comparator | Dietary Supplement: Seaweed extract3 capsules per day (1 before each meal) of seaweed extract |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body Mass Index (BMI) 25-35 kg/m2
- Not dieting within the last month and not having lost >5% body weight in the previous year
- Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
- Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice
- Able to eat most everyday foods
Key exclusion criteria (13 listed)
- Significant health problems (e.g. hypercholesterolaemia, diabetes, GI disorders)
- Taking any medication or supplements known to affect mineral or glucose metabolism within the past month and/or during the study
- Pregnant, planning to become pregnant or breastfeeding
- History of anaphylaxis to food
- Known allergies or intolerance to foods and/or to the study materials (or closely related compounds) or any of their stated ingredients
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 |
|---|---|---|
| Seaweed extract1 capsule 3 times per day | Dietary supplement | Seaweed extract |
| Placebo1 capsule 3 times per day | Dietary supplement | Placebo |
Primary outcome
Change in Plasma Glucose concentration
Time frame: 3 weeks
Changes in plasma glucose in healthy volunteers with BMI>25 after 3 weeks of treatment
Change of Plasma Insulin concentration
Time frame: 3 weeks
Changes in plasma insulin in healthy volunteers with BMI>25 after 3 weeks of treatment
Change in metabolic parameters
Time frame: 3 weeks
Changes in insulin sensitivity based on Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) test
2 secondary outcomes
Change in Blood Lipids
Time frame: 3 weeks
Change in plasma Markers of inflammation
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
George Tzortzis study director
BioAtlantis Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seaweed extract in people with Metabolic Syndrome and Insulin Sensitivity, run by BioAtlantis Ltd. at 1 site in United Kingdom.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 2 Mar 2022. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Plasma Glucose concentration (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2022.