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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04899791
• Other study ID #: Harokopio_EnrichedBread
• Status: Completed
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: February 2022
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 14, 2022
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type 2 Diabetes Mellitus

Intervention

Other:
• Wheat bread enriched with hydroxytyrosol
Wheat bread enriched with hydroxytyrosol
• Wheat bread
Wheat bread

Locations

Country	Name	City	State
Greece	Laiko General Hospital of Athens	Athens
Greece	Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens	Athens	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Harokopio University	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1C levels	Change in HbA1C levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread	12 weeks
Primary	Change in blood cholesterol levels	Change in blood cholesterol levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread	12 weeks
Secondary	Change in body weight		12 weeks