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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04899791

Enrollment

Registered

2021-05-24

Start date

2021-05-24

Completion date

2022-01-14

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes Mellitus

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.

Interventions

OTHERWheat bread enriched with hydroxytyrosol

Wheat bread enriched with hydroxytyrosol

OTHERWheat bread

Wheat bread

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Change in body weight	12 weeks

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026