Effects of Seaweed Extract on Postprandial Response to White Bread

Sponsor
University College Dublin (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05460884
Collaborator
(none)
20
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3
25.6
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Seaweed extract LD and white bread
  • Dietary Supplement: Seaweed extract HD and white bread
  • Dietary Supplement: White bread
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
physically incorporated in the intervention
Primary Purpose:
Prevention
Official Title:
Investigating the Effects of Seaweed Extract on Blood Glucose and Insulin Levels After a Meal in Healthy Subjects
Actual Study Start Date :
Sep 12, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Control

Participants will consume 109 g of white bread

Dietary Supplement: White bread
109g of white bread

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

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

Dietary Supplement: Seaweed extract LD and white bread
109g of white bread with 0.5g of seaweed extract

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

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

Dietary Supplement: Seaweed extract HD and white bread
109g of white bread with 1g of seaweed extract

Outcome Measures

Primary Outcome Measures

  1. Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within intervention groups vs. control. [Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min]

    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

  1. Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. control [Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min]

    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.

  2. Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. control [Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Food and Health Volunteer Suite; Science Center South, UCD Dublin Dublin 2 Ireland D02 X862 At this

Sponsors and Collaborators

  • University College Dublin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akristic, Assistant Professor, University College Dublin
ClinicalTrials.gov Identifier:
NCT05460884
Other Study ID Numbers:
  • LS-19-84
First Posted:
Jul 15, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Akristic, Assistant Professor, University College Dublin
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022