Back to resultsPositive 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
Primary Purpose
Type 2 Diabetes Mellitus, Obesity
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Wheat bread enriched with hydroxytyrosol
Wheat bread
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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)
Sites / Locations
- Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
- Laiko General Hospital of Athens
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wheat bread enriched with hydroxytyrosol
Wheat bread
Arm Description
Outcomes
Primary Outcome Measures
Change in HbA1C levels
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
Change in blood cholesterol levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread
Secondary Outcome Measures
Change in body weight
Full Information
NCT ID
NCT04899791
First Posted
May 19, 2021
Last Updated
February 28, 2022
Sponsor
Harokopio University
Collaborators
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT04899791
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
January 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
Collaborators
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wheat bread enriched with hydroxytyrosol
Arm Type
Experimental
Arm Title
Wheat bread
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Wheat bread enriched with hydroxytyrosol
Intervention Description
Wheat bread enriched with hydroxytyrosol
Intervention Type
Other
Intervention Name(s)
Wheat bread
Intervention Description
Wheat bread
Primary Outcome Measure Information:
Title
Change in HbA1C levels
Description
Change in HbA1C levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread
Time Frame
12 weeks
Title
Change in blood cholesterol levels
Description
Change in blood cholesterol levels after energy-restricted dietary intervention with wheat bread enriched with hydroxytyrosol compared to conventional wheat bread
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in body weight
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Laiko General Hospital of Athens
City
Athens
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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