Effects of Seaweed Extract on Postprandial Response to White Bread

Healthy Subjects Clinical Trial

Official title:

Investigating the Effects of Seaweed Extract on Blood Glucose and Insulin Levels After a Meal in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05460884
• Other study ID #: LS-19-84
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2023
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to determine whether seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin. It is designed as an acute, randomised, cross-over, controlled, three-arm dietary intervention trial in healthy subjects. Participants will be asked to consume either white bread, white bread with lower dose of seaweed extract or white bread with higher dose of seaweed extract.The effects on plasma glucose levels and levels of insulin will be determined over 3 hours after the consumption.

Description:

It has been shown in a large number of in vitro studies that seaweed extracts act as potent inhibitors of enzymes of carbohydrate digestion suggesting their potential to modulate postprandial glycaemic response and prevent the damaging effects of hyperglycaemic state. However, the results from human trials are limited and inconsistent.

The investigators confirmed that the in vitro inhibitory effects of seaweed extracts depend on the type, level and ratio of bioactive compounds, and optimised the composition of the extract to obtain the most potent one, to be tested in the proposed study.

The present study will determine whether the seaweed extract added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin or determined by the individual levels of digestive enzymes.

Healthy volunteers will be asked to consume three different meals: (1) white bread; (2) white bread with the lower dose (LD) of the extract; (3) white bread with the higher dose (HD) of the extract

The levels of glucose and insulin will be measured in plasma isolated from blood samples obtained before and up to 3 hours after the consumption of each meal.

Additional measurements taken at the screening will include blood pressure values and blood lipids levels. All participants will be characterized for the activity of salivary a-amylase.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old

• 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 or pollen

• 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 Risk
• Glucose Intolerance
• Glycemic Control
• Healthy Subjects
• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

Dietary Supplement:
• Seaweed extract LD and white bread
109g of white bread with 0.5g of seaweed extract
• Seaweed extract HD and white bread
109g of white bread with 1g of seaweed extract
• White bread
109g of white bread

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 plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control.	The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of both levels of seaweed extracts concomitantly with white bread, or white bread only, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).	Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Secondary	Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. control	The glucose iAUC will be determined from all incremental plasma glucose levels at the defined time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 min) after the consumption of test and control meals based on trapezoid rule.	Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Secondary	Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. control	nsulin levels measured at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.	Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min