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OpenTrials
Completed

NCT Number: NCT04725955

Postprandial Responses to Hydroxytyrosol-enriched Bread

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Athens, Attica, 11527, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enriched wheat bread

Other

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).

Primary outcomes

  1. Glycaemic Index

    Time frame: Change between preprandial glucose measurements until 120 minutes postprandially

    Glycaemic Index of the enriched breads

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2021
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.