Clinical trial NCT04725955: Postprandial Responses to Hydroxytyrosol-enriched Bread
Official title: Postprandial Responses of Healthy Subjects to Wheat Bread Enriched With Encapsulated Hydroxytyrosol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Responses
Keywords: hydroxytyrosol
a-cyclodextrin
bread
glycaemic index
appetite
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2021-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Glycaemic Index
timeFrame: Change between preprandial glucose measurements until 120 minutes postprandially
Secondary outcomes:
measure: Insulin Response
timeFrame: Change between preprandial insulin measurements until 180 minutes postprandially
measure: Appetite ratings
timeFrame: Change between preprandial subjective appetite measurements until 180 minutes postprandially
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
state: Attiki
Study officials:
References:
citation: Binou P, Stergiou A, Kosta O, Tentolouris N, Karathanos VT. Positive postprandial glycaemic and appetite-related effects of wheat breads enriched with either alpha-cyclodextrin or hydroxytyrosol/alpha-cyclodextrin inclusion complex. Eur J Nutr. 2022 Oct;61(7):3809-3819. doi: 10.1007/s00394-022-02913-z. Epub 2022 Jun 6.