Effects of Seaweed Extract on Blood Glucose Response to Sucrose

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461560
• Other study ID #: LS-21-54
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: University College Dublin
• Contact: Aleksandra Konic Ristic, PhD
• Phone: + 353 1 7162504
• Email: aleksandra.konicristic[@]ucd.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Healthy Diet
• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

Dietary Supplement:
• Sucrose solution
50 g of sucrose dissolved in 500 ml of tap water
• Seaweed extract in sucrose solution
1 g of seaweed extract in solution of 50 g of sucrose in 500 ml of tap water

Locations

Country	Name	City	State
Ireland	Institute of Food and Health Volunteer Suite; Science Center South, UCD	Dublin	Dublin 2

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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