Effects of Seaweed Extract on Blood Glucose Response to Sucrose

NCT ID: NCT05461560

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-05
• Study Completion Date: 2022-12-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control: Sucrose solution

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

Group Type: SHAM_COMPARATOR

Sucrose solution

Intervention Type: DIETARY_SUPPLEMENT

50 g of sucrose dissolved in 500 ml of tap water

Experimental: Seaweed extract in sucrose solution

Participants will consume 50g of sucrose and 1g of seaweed extract dissolved in 500 ml of tap water

Group Type: EXPERIMENTAL

Seaweed extract in sucrose solution

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Sucrose solution

50 g of sucrose dissolved in 500 ml of tap water

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Akristic

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Food and Health Volunteer Suite; Science Center South, UCD

Dublin, Dublin 2, Ireland

Site Status: RECRUITING

Countries

Ireland

Central Contacts

Aleksandra Konic Ristic, PhD

Role: CONTACT

aleksandra.konicristic@ucd.ie

+ 353 1 7162504

Eileen Gibney, PhD

Role: CONTACT

eileen.gibney@ucd.ie

+ 353 1 7162819

Facility Contacts

Aleksandra Konic Ristic, PhD

Role: primary

aleksandra.konicristic@ucd.ie

+ 353 1 7162504

Eileen Gibney, PhD

Role: backup

+ 353 1 7162819

Other Identifiers

LS-21-54

Identifier Type: -

Identifier Source: org_study_id