Clinical trial NCT05461560: Effects of Seaweed Extract on Blood Glucose Response to Sucrose
Official title: Investigating the Effects of Seaweed Extract on Postprandial Blood Glucose Response to Sucrose in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Intolerance
Diabetes Mellitus, Type 2
Healthy Diet
Postprandial Hyperglycemia
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Changes in maximal incremental capillary blood glucose level (iCmax) between baseline and endpoint within the intervention group vs. control.
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes
Secondary outcomes:
measure: Changes in area under the curve of incremental capillary blood glucose levels (iAUC) in the intervention group vs. control
timeFrame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Institute of Food and Health Volunteer Suite; Science Center South, UCD
state: Dublin 2
Study officials:
References: