Effects of Seaweed Extract on Blood Glucose Response to Sucrose

University College Dublin

Status: Enrolling

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

Treatments: Dietary Supplement: Sucrose solution; Dietary Supplement: Seaweed extract in sucrose solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05461560

LS-21-54

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Control: Sucrose solution

Sham Comparator group

Description:

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

Treatment:

Dietary Supplement: Sucrose solution

Experimental: Seaweed extract in sucrose solution

Experimental group

Description:

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

Treatment:

Dietary Supplement: Seaweed extract in sucrose solution