Glycemic ControlNCT05460884
Effects of Seaweed Extract on Postprandial Response to White Bread
A study testing Seaweed extract LD and white bread, Seaweed extract HD and white bread and White bread in people with Glycemic Control and Diabetes Mellitus Risk, run by University College Dublin at 1 site in Ireland.
Trial summary
The study is designed to determine whether seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Control, Diabetes Mellitus Risk, Glucose Intolerance
- What is being tested?
- Seaweed extract LD and white bread, Seaweed extract HD and white bread and White bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 12 Sep 2020to 31 Oct 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Healthy
Who cannot join
- Smoking
- Diagnosis of any chronic illness (including diabetes, hypertension, gastrointestinal diseases etc.)
- On long term prescribed medication (except contraceptives)
- Pregnant or lactating
- On a special diet or dietary regimen (for weight management or if regularly consuming fruit extract supplements)
- Allergy to fruits vegetables or pollen
Show all 9Show fewer
- Unwillingness to follow dietary recommendations or record the diet during recommended period
- Donated blood 4 weeks before or intend to donate blood during the study or 4 weeks after the last study samples
- Participation in another research project in parallel which also involves dietary intervention (e.g. taking vitamin supplements) or requires sampling of blood
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Institute of Food and Health Volunteer Suite; Science Center South, UCD
Dublin, Dublin 2, D02 X862 At this
About this study
Official title: Investigating the Effects of Seaweed Extract on Blood Glucose and Insulin Levels After a Meal in Healthy Subjects
The study is designed to determine whether seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin. It is designed as an acute, randomised, cross-over, controlled, three-arm dietary intervention trial in healthy subjects. Participants will be asked to consume either white bread, white bread with lower dose of seaweed extract or white bread with higher dose of seaweed extract.The effects on plasma glucose levels and levels of insulin will be determined over 3 hours after the consumption.
Read the detailed description
It has been shown in a large number of in vitro studies that seaweed extracts act as potent inhibitors of enzymes of carbohydrate digestion suggesting their potential to modulate postprandial glycaemic response and prevent the damaging effects of hyperglycaemic state. However, the results from human trials are limited and inconsistent.
The investigators confirmed that the in vitro inhibitory effects of seaweed extracts depend on the type, level and ratio of bioactive compounds, and optimised the composition of the extract to obtain the most potent one, to be tested in the proposed study.
The present study will determine whether the seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin or determined by the individual levels of digestive enzymes.
Healthy volunteers will be asked to consume three different meals: (1) white bread; (2) white bread with the lower dose (LD) of the extract; (3) white bread with the higher dose (HD) of the extract
The levels of glucose and insulin will be measured in plasma isolated from blood samples obtained before and up to 3 hours after the consumption of each meal.
Additional measurements taken at the screening will include blood pressure values and blood lipids levels. All participants will be characterized for the activity of salivary a-amylase.
- Conditions
- Glycemic Control, Diabetes Mellitus Risk, Glucose Intolerance, Postprandial Hyperglycemia, Healthy Subjects
- Being tested
- Seaweed extract LD and white bread, Seaweed extract HD and white bread, White bread
- Keywords
- seaweed, Ascophyllum, blood glucose, insulin, postprandial, hyperglycemia
- Medical subject headings
- Glucose Intolerance, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seaweed extract LD and white breadDietary supplement
109g of white bread with 0.5g of seaweed extract
Seaweed extract HD and white breadDietary supplement
109g of white bread with 1g of seaweed extract
White breadDietary supplement
109g of white bread
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Participants will consume 109 g of white bread Receives: Dietary Supplement: White bread |
| Experimental 1: Seaweed extract at lower dose (LD) and white bread | Experimental | Participants will consume 109 g of white bread with 0.5g of seaweed extract Receives: Dietary Supplement: Seaweed extract LD and white bread |
| Experimental 2: Seaweed extract at higher dose (HD) and white bread | Experimental | Participants will consume 109 g of white bread with 1g of seaweed extract Receives: Dietary Supplement: Seaweed extract HD and white bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control.
The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of both levels of seaweed extracts concomitantly with white bread, or white bread only, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).
Measured: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Secondary outcomes (2)
Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. control
The glucose iAUC will be determined from all incremental plasma glucose levels at the defined time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 min) after the consumption of test and control meals based on trapezoid rule.
Measured: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. control
nsulin levels measured at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
Measured: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start12 Sep 2020
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ControlStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akristic, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460884
- Sponsor's protocol ID
- LS-19-84
- Status last verified
- Feb 2023
- First submitted
- 13 Jul 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be archived in an anonymised form. Following completion of the study the data will only be accessible by the PIs. Access to the data by a 3rd party will only be given through collaboration with one of the existing PIs. The data may be shared for other research projects, and in an anonymised form. Consent to share the data for such purposes is requested in the study consent form.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Seaweed Extract on Blood Glucose and Insulin Levels After a Meal in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05460884
- Acronym / sponsor ID
- LS-19-84
- Conditions
- Glycemic Control, Diabetes Mellitus Risk, Glucose Intolerance, Postprandial Hyperglycemia, Healthy Subjects
- Keywords
- seaweed, Ascophyllum, blood glucose, insulin, postprandial, hyperglycemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 15 Jul 2022 (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.
The study is designed to determine whether seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin. It is designed as an acute, randomised, cross-over, controlled, three-arm dietary intervention trial in healthy subjects. Participants will be asked to consume either white bread, white bread with lower dose of seaweed extract or white bread with higher dose of seaweed extract.The effects on plasma glucose levels and levels of insulin will be determined over 3 hours after the consumption.
Detailed description
It has been shown in a large number of in vitro studies that seaweed extracts act as potent inhibitors of enzymes of carbohydrate digestion suggesting their potential to modulate postprandial glycaemic response and prevent the damaging effects of hyperglycaemic state. However, the results from human trials are limited and inconsistent.
The investigators confirmed that the in vitro inhibitory effects of seaweed extracts depend on the type, level and ratio of bioactive compounds, and optimised the composition of the extract to obtain the most potent one, to be tested in the proposed study.
The present study will determine whether the seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin or determined by the individual levels of digestive enzymes.
Healthy volunteers will be asked to consume three different meals: (1) white bread; (2) white bread with the lower dose (LD) of the extract; (3) white bread with the higher dose (HD) of the extract
The levels of glucose and insulin will be measured in plasma isolated from blood samples obtained before and up to 3 hours after the consumption of each meal.
Additional measurements taken at the screening will include blood pressure values and blood lipids levels. All participants will be characterized for the activity of salivary a-amylase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Dietary Supplement: White breadParticipants will consume 109 g of white bread |
| Experimental 1: Seaweed extract at lower dose (LD) and white bread | Experimental | Dietary Supplement: Seaweed extract LD and white breadParticipants will consume 109 g of white bread with 0.5g of seaweed extract |
| Experimental 2: Seaweed extract at higher dose (HD) and white bread | Experimental | Dietary Supplement: Seaweed extract HD and white breadParticipants will consume 109 g of white bread with 1g of seaweed extract |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old
- Healthy
Key exclusion criteria (9 listed)
- Smoking
- Diagnosis of any chronic illness (including diabetes, hypertension, gastrointestinal diseases etc.)
- On long term prescribed medication (except contraceptives)
- Pregnant or lactating
- On a special diet or dietary regimen (for weight management or if regularly consuming fruit extract supplements)
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 extract LD and white bread109g of white bread with 0.5g of seaweed extract | Dietary supplement | Experimental 1: Seaweed extract at lower dose (LD) and white bread |
| Seaweed extract HD and white bread109g of white bread with 1g of seaweed extract | Dietary supplement | Experimental 2: Seaweed extract at higher dose (HD) and white bread |
| White bread109g of white bread | Dietary supplement | Control |
Primary outcome
Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control.
Time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of both levels of seaweed extracts concomitantly with white bread, or white bread only, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).
2 secondary outcomes
Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. control
Time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. control
Time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No. Data will be archived in an anonymised form. Following completion of the study the data will only be accessible by the PIs. Access to the data by a 3rd party will only be given through collaboration with one of the existing PIs. The data may be shared for other research projects, and in an anonymised form. Consent to share the data for such purposes is requested in the study consent form.
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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 Seaweed extract LD and white bread, Seaweed extract HD and white bread and White bread in people with Glycemic Control and Diabetes Mellitus Risk, run by University College Dublin at 1 site in Ireland.
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 2 inclusion and 9 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 21 Feb 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 Ireland. 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?
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?
Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control. (time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min). 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 21 Feb 2023.