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Effects of Seaweed Extract on Postprandial Response to White Bread

Primary Purpose

Glycemic Control, Diabetes Mellitus Risk, Glucose Intolerance

Status
Active
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Seaweed extract LD and white bread
Seaweed extract HD and white bread
White bread
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glycemic Control focused on measuring seaweed, Ascophyllum, blood glucose, insulin, postprandial, hyperglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control

Experimental 1: Seaweed extract at lower dose (LD) and white bread

Experimental 2: Seaweed extract at higher dose (HD) and white bread

Arm Description

Participants will consume 109 g of white bread

Participants will consume 109 g of white bread with 0.5g of seaweed extract

Participants will consume 109 g of white bread with 1g of seaweed extract

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 13, 2022
Last Updated
February 17, 2023
Sponsor
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT05460884
Brief Title
Effects of Seaweed Extract on Postprandial Response to White Bread
Official Title
Investigating the Effects of Seaweed Extract on Blood Glucose and Insulin Levels After a Meal in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glycemic Control, Diabetes Mellitus Risk, Glucose Intolerance, Postprandial Hyperglycemia, Healthy Subjects
Keywords
seaweed, Ascophyllum, blood glucose, insulin, postprandial, hyperglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
physically incorporated in the intervention
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Participants will consume 109 g of white bread
Arm Title
Experimental 1: Seaweed extract at lower dose (LD) and white bread
Arm Type
Experimental
Arm Description
Participants will consume 109 g of white bread with 0.5g of seaweed extract
Arm Title
Experimental 2: Seaweed extract at higher dose (HD) and white bread
Arm Type
Experimental
Arm Description
Participants will consume 109 g of white bread with 1g of seaweed extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Seaweed extract LD and white bread
Intervention Description
109g of white bread with 0.5g of seaweed extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Seaweed extract HD and white bread
Intervention Description
109g of white bread with 1g of seaweed extract
Intervention Type
Dietary Supplement
Intervention Name(s)
White bread
Intervention Description
109g of white bread
Primary Outcome Measure Information:
Title
Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control.
Description
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).
Time Frame
Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Secondary Outcome Measure Information:
Title
Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. control
Description
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.
Time Frame
Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
Title
Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. control
Description
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.
Time Frame
Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Food and Health Volunteer Suite; Science Center South, UCD
City
Dublin
State/Province
Dublin 2
ZIP/Postal Code
D02 X862 At this
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be archived in an anonymised form. Following completion of the study the data will only be accessible by the PIs. 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.

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Effects of Seaweed Extract on Postprandial Response to White Bread

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