Effects of Seaweed Extract on Blood Glucose Response to Sucrose

Sponsor

University College Dublin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05461560

Collaborator

(none)

Enrollment

Location

Arms

12.8

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose Intolerance Diabetes Mellitus, Type 2 Healthy Diet Postprandial Hyperglycemia	Dietary Supplement: Sucrose solution Dietary Supplement: Seaweed extract in sucrose solution	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 5, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control: Sucrose solution Participants will consume 50g of sucrose dissolved in 500 ml of tap water	Dietary Supplement: Sucrose solution 50 g of sucrose dissolved in 500 ml of tap water
Experimental: Experimental: Seaweed extract in sucrose solution 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 1 g of seaweed extract in solution of 50 g of sucrose in 500 ml of tap water

Arm

Intervention/Treatment

Sham Comparator: Control: Sucrose solution

Participants will consume 50g of sucrose dissolved in 500 ml of tap water

Dietary Supplement: Sucrose solution

50 g of sucrose dissolved in 500 ml of tap water

Experimental: Experimental: Seaweed extract in sucrose solution

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

1 g of seaweed extract in solution of 50 g of sucrose in 500 ml of tap water

Outcome Measures

Primary Outcome Measures

Changes in maximal incremental capillary blood glucose level (iCmax) between baseline and endpoint within the intervention group vs. control. [Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes]
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 [Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Food and Health Volunteer Suite; Science Center South, UCD	Dublin	Dublin 2	Ireland	D02 X862 At this

Sponsors and Collaborators

University College Dublin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Akristic, Assistant Professor, University College Dublin

ClinicalTrials.gov Identifier:

NCT05461560

Other Study ID Numbers:

LS-21-54

First Posted:

Jul 18, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Hyperglycemia

Glucose Intolerance

Pharmaceutical Solutions

Study Results

No Results Posted as of Jul 19, 2022