Effects of Seaweed Extract on Blood Glucose Response to Sucrose

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Glucose Intolerance; Healthy Diet; Postprandial Hyperglycemia
• Intervention / Treatment: Dietary supplement: Sucrose solution; Dietary supplement: Seaweed extract in sucrose solution

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksandra Konic Ristic, PhD; Phone Number: + 353 1 7162504; Email: aleksandra.konicristic@ucd.ie
• Study Contact Backup: Name: Eileen Gibney, PhD; Phone Number: + 353 1 7162819; Email: eileen.gibney@ucd.ie

Study Locations

• Ireland
  • Dublin 2
    • Dublin, Dublin 2, Ireland, D02 X862 At this
      • Recruiting
      • Institute of Food and Health Volunteer Suite; Science Center South, UCD
      • Contact: Aleksandra Konic Ristic, PhD; Phone Number: + 353 1 7162504; Email: aleksandra.konicristic@ucd.ie
      • Contact: Eileen Gibney, PhD; Phone Number: + 353 1 7162819

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: University College Dublin

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2021
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (ACTUAL): July 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2; Glucose Intolerance; Pharmaceutical Solutions
• Other Study ID Numbers: LS-21-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No