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

NCT ID: NCT04899791

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2022-01-14

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.

Conditions

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Type 2 Diabetes Mellitus Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Wheat bread enriched with hydroxytyrosol

Group Type EXPERIMENTAL

Wheat bread enriched with hydroxytyrosol

Intervention Type OTHER

Wheat bread enriched with hydroxytyrosol

Wheat bread

Group Type ACTIVE_COMPARATOR

Wheat bread

Intervention Type OTHER

Wheat bread

Interventions

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Wheat bread enriched with hydroxytyrosol

Wheat bread enriched with hydroxytyrosol

Intervention Type OTHER

Wheat bread

Wheat bread

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Vaios T. Karathanos

Professor of Food Engineering and Physical Chemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Athens, Attica, Greece

Site Status

Laiko General Hospital of Athens

Athens, , Greece

Site Status

Countries

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Greece

References

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Binou P, Stergiou A, Kosta O, Tentolouris N, Karathanos VT. Positive contribution of hydroxytyrosol-enriched wheat bread to HbA1c levels, lipid profile, markers of inflammation and body weight in subjects with overweight/obesity and type 2 diabetes mellitus. Eur J Nutr. 2023 Aug;62(5):2165-2176. doi: 10.1007/s00394-023-03133-9. Epub 2023 Apr 5.

Reference Type DERIVED
PMID: 37017765 (View on PubMed)

Other Identifiers

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Harokopio_EnrichedBread

Identifier Type: -

Identifier Source: org_study_id

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