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Trial record 4 of 15 for:    cyclodextrin | Recruiting, Not yet recruiting Studies

Postprandial Responses to Hydroxytyrosol-enriched Bread

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ClinicalTrials.gov Identifier: NCT04725955
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : May 20, 2021
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Vaios T. Karathanos, Harokopio University

Brief Summary:

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 bread enriched with a-cyclodextrin or 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.


Condition or disease Intervention/treatment Phase
Postprandial Responses Other: Enriched wheat bread Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Postprandial Responses of Healthy Subjects to Wheat Bread Enriched With Encapsulated Hydroxytyrosol
Actual Study Start Date : January 31, 2021
Actual Primary Completion Date : April 30, 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Placebo Comparator: Glucose Solution Other: Enriched wheat bread
Either 50g of glucose dissolved in 250mL water 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 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 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).




Primary Outcome Measures :
  1. Glycaemic Index [ Time Frame: Change between preprandial glucose measurements until 120 minutes postprandially ]
    Glycaemic Index of the enriched breads


Secondary Outcome Measures :
  1. 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)

  2. 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)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725955


Contacts
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Contact: Vaios Karathanos, Professor +302109549224 vkarath@hua.gr

Locations
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Greece
Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens Recruiting
Athens, Attiki, Greece, 11527
Contact: Nikolaos Tentolouris, Professor    +302107470089    ntentol@med.uoa.gr   
Sponsors and Collaborators
Harokopio University
National and Kapodistrian University of Athens
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Responsible Party: Vaios T. Karathanos, Professor of Food Engineering and Physical Chemistry, Harokopio University
ClinicalTrials.gov Identifier: NCT04725955    
Other Study ID Numbers: Harokopio_Hydroxytyrosol
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vaios T. Karathanos, Harokopio University:
hydroxytyrosol
a-cyclodextrin
bread
glycaemic index
appetite