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

Harokopio University

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Obesity

Treatments: Other: Wheat bread; Other: Wheat bread enriched with hydroxytyrosol

Study type: Interventional

Funder types: Other

Identifiers

NCT04899791

Harokopio_EnrichedBread

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Wheat bread enriched with hydroxytyrosol

Experimental group

Treatment:

Other: Wheat bread enriched with hydroxytyrosol

Wheat bread

Active Comparator group

Treatment:

Other: Wheat bread