Postprandial Responses to Hydroxytyrosol-enriched Bread

Not Applicable

Completed

• Conditions: Postprandial Responses
• Interventions: Other: Enriched wheat bread

• Registration Number: NCT04725955
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-27
• Study Start: 2021-01-31
• Primary Completion: 2021-04-30
• Status Verified: 2021-11
• Study Completion: 2021-11-15
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose Solution	Enriched wheat bread	-
White wheat bread	Enriched wheat bread	-
Wheat bread enriched with a-cyclodextrin	Enriched wheat bread	-
Wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin	Enriched wheat bread	-

Primary Outcome Measures

Name	Time	Method
Glycaemic Index	Change between preprandial glucose measurements until 120 minutes postprandially	Glycaemic Index of the enriched breads

Secondary Outcome Measures

Name	Time	Method
Insulin Response	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)
Appetite ratings	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)

Trial Locations

Locations (1)

Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens; 🇬🇷 Athens, Attiki, Greece