Effects of Seaweed Extract on Blood Glucose Response to Sucrose

Study Overview
=================
Brief Summary
-----------------
This study will examine the impact of the seaweed (Ascophyllum nodosum) extract on blood glucose levels after a sugary drink in healthy subjects. The aim of this study is to investigate if the seaweed extract, when consumed with the sucrose, can lower blood glucose levels, compared to the raise after sucrose only, in healthy volunteers. The study is designed as an acute, double-blind, randomised, controlled crossover trial in 16 healthy subjects. Participants will be asked to consume sucrose solution or sucrose solution with added seaweed extract.The effects on blood glucose levels will be determined over 2 hours after the consumption.

Detailed Description
-----------------
Blood glucose levels after a meal rich in sugars depend, among other factors, on the activity of enzymes that digest sugar molecules to glucose. Epidemiological studies suggest that glucose levels after a meal higher than normal, present a great risk for the onset of cardiovascular diseases. Slowing the digestion of sugar through the inhibition of digestion enzymes have been demonstrated as a successful approach in preventing postprandial hyperglycaemia either with pharmacological agents (acarbose, miglitol) or natural dietary compounds. We demonstrated, in preclinical in vitro experiments, the unique potential of tested seaweed extract to inhibit rat sucrase. This study will examine the potential of the seaweed extract to modulate blood glucose levels after a sucrose drink in healthy subjects . The aim of this study is to investigate if the seaweed extract, when consumed with sucrose, can lower blood glucose levels, compared to the raise after sucrose only. The study is designed as an acute, double-blind, randomised, controlled crossover trial in 16 healthy subjects. Participants will be asked to consume sucrose solution or sucrose solution with added seaweed extract.The effects on blood glucose levels (in capillary blood) will be determined over 2 hours after the consumption. All participants will be characterized for the activity of salivary a-amylase

Official Title
-----------------
Investigating the Effects of Seaweed Extract on Postprandial Blood Glucose Response to Sucrose in Healthy Subjects

Conditions
-----------------
Glucose Intolerance, Diabetes Mellitus, Type 2, Healthy Diet, Postprandial Hyperglycemia

Intervention / Treatment
-----------------
* Dietary Supplement: Sucrose solution
* Dietary Supplement: Seaweed extract in sucrose solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 years 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, pollen or seaweed. 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
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control: Sucrose solution<br>Participants will consume 50g of sucrose dissolved in 500 ml of tap water | Dietary Supplement: Sucrose solution<br>* 50 g of sucrose dissolved in 500 ml of tap water<br>|
| Experimental: Experimental: Seaweed extract in sucrose solution<br>Participants will consume 50g of sucrose and 1g of seaweed extract dissolved in 500 ml of tap water | Dietary Supplement: Seaweed extract in sucrose solution<br>* 1 g of seaweed extract in solution of 50 g of sucrose in 500 ml of tap water<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in maximal incremental capillary blood glucose level (iCmax) between baseline and endpoint within the intervention group vs. control. | The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120 minutes) as the change in capillary blood glucose levels after the consumption of seaweed extract in sucrose solution or sucrose solution, compared to the glucose levels before the consumption of test drinks (baseline value, t=0 minutes) | Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in area under the curve of incremental capillary blood glucose levels (iAUC) in the intervention group vs. control | The glucose iAUC will be determined from all incremental capillary blood glucose levels at the defined time points (0, 15, 30, 45, 60, 90, 120 minutes) after the consumption of test and control drinks based on trapezoid rule. | Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes |