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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
NA trial testing Wheat bread enriched with hydroxytyrosol in Type 2 Diabetes Mellitus in 60 participants. Completed in 14 January 2022.
24 December 2021
Quick facts
| Lead sponsor | Harokopio University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 24 May 2021 |
| Primary completion | 24 December 2021 |
| Estimated completion | 14 January 2022 |
| Sites | 2 locations across Greece |
Drugs / interventions tested
- Wheat bread enriched with hydroxytyrosol
- Wheat bread
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
- Obesity — all drugs for Obesity →
Sponsor
Harokopio University
Who can join
Adults 18 to 75, any sex, with Type 2 Diabetes Mellitus or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Positive contribution of hydroxytyrosol-enriched wheat bread to HbA<sub>1</sub>c levels, lipid profile, markers of inflammation and body weight in subjects with overweight/obesity and type 2 diabetes mellitus.
Binou P, Stergiou A, Kosta O, Tentolouris N, et al · · 2023 · cited 11× · PMID 37017765 · DOI 10.1007/s00394-023-03133-9
Verify or expand the search:
- PubMed search for NCT04899791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Harokopio University trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04899791 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harokopio University
- Last refreshed: 2 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04899791.
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