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Completed

NCT Number: NCT04899791

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

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Wheat bread enriched with hydroxytyrosol

Other

Wheat bread enriched with hydroxytyrosol

Wheat bread

Other

Wheat bread

Primary outcomes

  1. Change in HbA1C levels

    Time frame: 12 weeks

    Change in HbA1C levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread

  2. Change in blood cholesterol levels

    Time frame: 12 weeks

    Change in blood cholesterol levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread

Secondary outcomes

  1. Change in body weight

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 24, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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