Effects of Seaweed Extract on Blood Glucose Response to Sucrose
Primary Purpose
Glucose Intolerance, Diabetes Mellitus, Type 2, Healthy Diet
Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Sucrose solution
Seaweed extract in sucrose solution
Sponsored by
About this trial
This is an interventional prevention trial for Glucose Intolerance
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
Sites / Locations
- Institute of Food and Health Volunteer Suite; Science Center South, UCDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control: Sucrose solution
Experimental: Seaweed extract in sucrose solution
Arm Description
Participants will consume 50g of sucrose dissolved in 500 ml of tap water
Participants will consume 50g of sucrose and 1g of seaweed extract dissolved in 500 ml of tap water
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05461560
Brief Title
Effects of Seaweed Extract on Blood Glucose Response to Sucrose
Official Title
Investigating the Effects of Seaweed Extract on Postprandial Blood Glucose Response to Sucrose in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Diabetes Mellitus, Type 2, Healthy Diet, Postprandial Hyperglycemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control: Sucrose solution
Arm Type
Sham Comparator
Arm Description
Participants will consume 50g of sucrose dissolved in 500 ml of tap water
Arm Title
Experimental: Seaweed extract in sucrose solution
Arm Type
Experimental
Arm Description
Participants will consume 50g of sucrose and 1g of seaweed extract dissolved in 500 ml of tap water
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucrose solution
Intervention Description
50 g of sucrose dissolved in 500 ml of tap water
Intervention Type
Dietary Supplement
Intervention Name(s)
Seaweed extract in sucrose solution
Intervention Description
1 g of seaweed extract in solution of 50 g of sucrose in 500 ml of tap water
Primary Outcome Measure Information:
Title
Changes in maximal incremental capillary blood glucose level (iCmax) between baseline and endpoint within the intervention group vs. control.
Description
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)
Time Frame
Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes
Secondary Outcome Measure Information:
Title
Changes in area under the curve of incremental capillary blood glucose levels (iAUC) in the intervention group vs. control
Description
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.
Time Frame
Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra Konic Ristic, PhD
Phone
+ 353 1 7162504
Email
aleksandra.konicristic@ucd.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Gibney, PhD
Phone
+ 353 1 7162819
Email
eileen.gibney@ucd.ie
Facility Information:
Facility Name
Institute of Food and Health Volunteer Suite; Science Center South, UCD
City
Dublin
State/Province
Dublin 2
ZIP/Postal Code
D02 X862 At this
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra Konic Ristic, PhD
Phone
+ 353 1 7162504
Email
aleksandra.konicristic@ucd.ie
First Name & Middle Initial & Last Name & Degree
Eileen Gibney, PhD
Phone
+ 353 1 7162819
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Learn more about this trial
Effects of Seaweed Extract on Blood Glucose Response to Sucrose
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