Postprandial Responses to Hydroxytyrosol-enriched Bread

NCT ID: NCT04725955

Last Updated: 2021-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2021-11-15

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.

Conditions

Postprandial Responses

Keywords

hydroxytyrosol; a-cyclodextrin; bread; glycaemic index; appetite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Glucose Solution

Group Type: PLACEBO_COMPARATOR

Enriched wheat bread

Intervention Type: 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).

Wheat bread enriched with a-cyclodextrin

Group Type: ACTIVE_COMPARATOR

Enriched wheat bread

Intervention Type: 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).

Wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin

Group Type: EXPERIMENTAL

Enriched wheat bread

Intervention Type: 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).

White wheat bread

Group Type: PLACEBO_COMPARATOR

Enriched wheat bread

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: collaborator

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

Vaios T. Karathanos

Professor of Food Engineering and Physical Chemistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Athens, Attica, Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 35668121 (View on PubMed)

Other Identifiers

Harokopio_Hydroxytyrosol

Identifier Type: -

Identifier Source: org_study_id