Effects of Seaweed Extract on Postprandial Response to White Bread

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Effects of Seaweed Extract on Blood Glucose and Insulin Levels After a Meal in Healthy Subjects

Conditions
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Glycemic Control, Diabetes Mellitus Risk, Glucose Intolerance, Postprandial Hyperglycemia, Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: Seaweed extract LD and white bread
* Dietary Supplement: Seaweed extract HD and white bread
* Dietary Supplement: White bread


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Healthy Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Participants will consume 109 g of white bread | Dietary Supplement: White bread<br>* 109g of white bread<br>|
| Experimental: Experimental 1: Seaweed extract at lower dose (LD) and white bread<br>Participants will consume 109 g of white bread with 0.5g of seaweed extract | Dietary Supplement: Seaweed extract LD and white bread<br>* 109g of white bread with 0.5g of seaweed extract<br>|
| Experimental: Experimental 2: Seaweed extract at higher dose (HD) and white bread<br>Participants will consume 109 g of white bread with 1g of seaweed extract | Dietary Supplement: Seaweed extract HD and white bread<br>* 109g of white bread with 1g of seaweed extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seaweed, Ascophyllum, blood glucose, insulin, postprandial, hyperglycemia