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

NCT04899791 | Completed

• 1 other identifier: Harokopio_EnrichedBread
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Type 2 Diabetes Mellitus; Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in body weight

  12 weeks

Study Arms (2)

Wheat bread enriched with hydroxytyrosol

EXPERIMENTAL

Other: Wheat bread enriched with hydroxytyrosol

Wheat bread

ACTIVE COMPARATOR

Other: Wheat bread

Interventions

Wheat bread enriched with hydroxytyrosol OTHER

Wheat bread enriched with hydroxytyrosol

Wheat bread enriched with hydroxytyrosol

Wheat bread OTHER

Wheat bread

Wheat bread

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes mellitus
• bmi : 25-40 kg/ m-2
• normal exercise and dietary habits
• weight stable for at least 3 months before enrollment

You may not qualify if:

• HbA1C \> 8.5%
• pregnancy
• chronic medical illness
• regular intense exercise
• alcohol consumption (\> 2 drinks/day)

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (2)

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

Athens, Attica, 11527, Greece

Location

Laiko General Hospital of Athens

Athens, Greece

Location

Related Publications (1)

• 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.

  PMID: 37017765 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

3,4-dihydroxyphenylethanol

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Food Engineering and Physical Chemistry

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: May 24, 2021
• Primary Completion: December 24, 2021
• Study Completion: January 14, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)