NCT05461560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

July 13, 2022

Last Update Submit

July 15, 2022

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2Healthy DietPostprandial Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Changes in maximal incremental capillary blood glucose level (iCmax) between baseline and endpoint within the intervention group vs. control.

    The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120 minutes) as the change in capillary blood glucose levels after the consumption of seaweed extract in sucrose solution or sucrose solution, compared to the glucose levels before the consumption of test drinks (baseline value, t=0 minutes)

    Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes

Secondary Outcomes (1)

  • Changes in area under the curve of incremental capillary blood glucose levels (iAUC) in the intervention group vs. control

    Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes

Study Arms (2)

Control: Sucrose solution

SHAM COMPARATOR

Participants will consume 50g of sucrose dissolved in 500 ml of tap water

Dietary Supplement: Sucrose solution

Experimental: Seaweed extract in sucrose solution

EXPERIMENTAL

Participants will consume 50g of sucrose and 1g of seaweed extract dissolved in 500 ml of tap water

Dietary Supplement: Seaweed extract in sucrose solution

Interventions

Sucrose solutionDIETARY_SUPPLEMENT

50 g of sucrose dissolved in 500 ml of tap water

Control: Sucrose solution
Seaweed extract in sucrose solutionDIETARY_SUPPLEMENT

1 g of seaweed extract in solution of 50 g of sucrose in 500 ml of tap water

Experimental: Seaweed extract in sucrose solution

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • 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, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dublin, Dublin 2, D02 X862 At this, Ireland

RECRUITING

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2Hyperglycemia

Interventions

sodium lactobionate sucrose solution

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Aleksandra Konic Ristic, PhD

CONTACT

+ 353 1 7162504aleksandra.konicristic@ucd.ie

Eileen Gibney, PhD

CONTACT

+ 353 1 7162819eileen.gibney@ucd.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
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 18, 2022

Study Start

December 5, 2021

Primary Completion

August 31, 2022

Study Completion

December 31, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL

Locations

IE(1)