Postprandial Responses to Hydroxytyrosol-enriched Bread

November 24, 2021 updated by: Vaios T. Karathanos, Harokopio University

Postprandial Responses of Healthy Subjects to Wheat Bread Enriched With Encapsulated Hydroxytyrosol

The amelioration of postprandial glucose and insulin responses to bread is of great importance since it may have significant beneficial effects on health. A number of studies have shown that hydroxytyrosol may have positive metabolic effects. However, this compound presents high hydrophilicity which constitutes the major barrier to its potential application in foods. Microencapsulation arises as a technological strategy to protect it and increase its stability. Alpha-cyclodextrin besides being a great carrier molecule, seems to also be beneficial to postprandial glucose levels. Enrichment of bread with encapsulated hydroxytyrosol could examine potential postprandial benefits.

Ten healthy normoglycemic subjects will participate in the study and will be provided with either a solution of glucose (reference food) or white wheat bread or wheat bread enriched with a-cyclodextrin or wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin, with 1-week intervals in amounts that yielded 50 g of available carbohydrates. Venous blood samples will be collected before consumption and at 30, 45, 60, 90, 120 and 180 min postprandially. Postprandial glucose, insulin and appetite-related hormone responses as well as glycemic index (GI) and subjective appetite ratings will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11527
        • Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal body mass index
  • Stable body weight for at least 3 months before enrollment
  • Normal exercise, eating and drinking habits

Exclusion Criteria:

  • Pregnancy and lactation
  • Chronic medical illness (diabetes mellitus, cardiovascular disease, chronic liver, kidney, polycystic ovary syndrome or untreated thyroid disease)
  • Use of nutritional supplements
  • History of drug and/or alcohol abuse
  • Psychiatric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Glucose Solution
Other: Enriched wheat bread
Either 50g of glucose dissolved in 250mL water or white wheat bread or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates).
ACTIVE_COMPARATOR: Wheat bread enriched with a-cyclodextrin
Other: Enriched wheat bread
Either 50g of glucose dissolved in 250mL water or white wheat bread or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates).
EXPERIMENTAL: Wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin
Other: Enriched wheat bread
Either 50g of glucose dissolved in 250mL water or white wheat bread or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates).
PLACEBO_COMPARATOR: White wheat bread
Other: Enriched wheat bread
Either 50g of glucose dissolved in 250mL water or white wheat bread or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic Index
Time Frame: Change between preprandial glucose measurements until 120 minutes postprandially
Glycaemic Index of the enriched breads
Change between preprandial glucose measurements until 120 minutes postprandially

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Response
Time Frame: Change between preprandial insulin measurements until 180 minutes postprandially
Insulin Responses of the volunteers to the enriched breads (by a sandwich ELISA method, using a commercially available human insulin kit)
Change between preprandial insulin measurements until 180 minutes postprandially
Appetite ratings
Time Frame: Change between preprandial subjective appetite measurements until 180 minutes postprandially
Appetite ratings after the consumption of the enriched breads (evaluation of subjective appetite ratings, use of visual analogue scales)
Change between preprandial subjective appetite measurements until 180 minutes postprandially

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 31, 2021

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

November 15, 2021

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (ACTUAL)

January 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Harokopio_Hydroxytyrosol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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