Positive Effects of Daily Consumption of Bread Enriched With Hydroxytyrosol on the Results of a 12-week Dietary Intervention on Subjects With Type 2 Diabetes Mellitus and Overweight/ Obesity

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity
• Interventions: Other: Wheat bread enriched with hydroxytyrosol; Other: Wheat bread

• Registration Number: NCT04899791
• Lead Sponsor: Harokopio University

Brief Summary

Hydroxytyrosol is a phenolic compound drawn from the olive tree and its leaves as a by-product obtained from the manufacturing of olive oil and has antioxidant and antidiabetic effects. The use of HT extract in food products is a good strategy to improve their nutritional quality. However, this extract has a strong odour and flavour, so it is important to be encapsulated for the odour and flavour to be covered up. The purpose of the study is to investigate the effects of regular consumption of bread enriched with HT on biochemical parameters (blood glucose and cholesterol levels).

Detailed Description

Subjects with type 2 diabetes mellitus and overweight/ obesity will participate in the present study. They will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of bread enriched with hydroxytyrosol. The effects of the dietary intervention on biochemical parameters (blood glucose and cholesterol levels) and body weight reduction will be examined.

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-21
• Study Start: 2021-05-24
• Study First Posted: 2021-05-24
• Primary Completion: 2021-12-24
• Study Completion: 2022-01-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• type 2 diabetes mellitus
• bmi : 25-40 kg/ m-2
• normal exercise and dietary habits
• weight stable for at least 3 months before enrollment

Exclusion Criteria

• HbA1C > 8.5%
• pregnancy
• chronic medical illness
• regular intense exercise
• alcohol consumption (> 2 drinks/day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wheat bread enriched with hydroxytyrosol	Wheat bread enriched with hydroxytyrosol	-
Wheat bread	Wheat bread	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1C levels	12 weeks	Change in HbA1C levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread
Change in blood cholesterol levels	12 weeks	Change in blood cholesterol levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread

Secondary Outcome Measures

Name	Time	Method
Change in body weight	12 weeks

Trial Locations

Locations (2)

Laiko General Hospital of Athens; 🇬🇷 Athens, Greece

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