Effects of Seaweed Extract on Postprandial Response to White Bread

NCT05460884 | Unknown DMC

• 1 other identifier: LS-19-84
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycemic Control; Diabetes Mellitus Risk; Glucose Intolerance; Postprandial Hyperglycemia; Healthy Subjects

Keywords

seaweed; Ascophyllum; blood glucose; insulin; postprandial; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (3)

Control

SHAM COMPARATOR

Participants will consume 109 g of white bread

Dietary Supplement: White bread

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

EXPERIMENTAL

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

Dietary Supplement: Seaweed extract LD and white bread

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

EXPERIMENTAL

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

Dietary Supplement: Seaweed extract HD and white bread

Interventions

Seaweed extract LD and white bread DIETARY_SUPPLEMENT

109g of white bread with 0.5g of seaweed extract

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

Seaweed extract HD and white bread DIETARY_SUPPLEMENT

109g of white bread with 1g of seaweed extract

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

White bread DIETARY_SUPPLEMENT

109g of white bread

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

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

Dublin, Dublin 2, D02 X862 At this, Ireland

Location

MeSH Terms

Conditions

Glucose Intolerance; Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: physically incorporated in the intervention
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: September 12, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)