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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Obesity

Intervention / Treatment
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* Other: Wheat bread enriched with hydroxytyrosol
* Other: Wheat bread


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wheat bread enriched with hydroxytyrosol<br> | Other: Wheat bread enriched with hydroxytyrosol<br>* Wheat bread enriched with hydroxytyrosol<br>|
| Active Comparator: Wheat bread<br> | Other: Wheat bread<br>* Wheat bread<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | 12 weeks |