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| Name | Class |
|---|---|
| Ospedali Riuniti di Foggia | OTHER |
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The purpose of this clinical study is to evaluate the health properties of a dietary intervention carried on with an innovative low-salt bread.
The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may improve the compliance to the own regime and that the vascular function, the inflammatory and oxidative state, the composition of the intestinal microbiota and that neurocognitive and neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with low-salt bread.
This clinical trial is a multi-center, randomized, controlled, open label, pilot study, lasting 6 months.
A target number of seventy individuals with hypertension meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - control | No Intervention | Free diet with standard bread | |
| B - low-salt diet with normal bread | Active Comparator | Low-sodium diet with standard bread |
|
| C - low-salt diet with low-salt bread | Experimental | Low-sodium diet with low-sodium bread |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-sodium diet with standard bread | Dietary Supplement | low-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sodium intake | Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Reduction of blood pressure | 6 months |
| Endothelial stress | Improvement of flow-mediated dilation FMD | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loreto Gesualdo, MD Full Prof | Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUO Policlinico Consorziale | Bari | BA | 70125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38383476 | Derived | Cosola C, Pesce F, De Angelis M, Maranzano V, Zito A, Montemurno E, Dalfino G, Loiudice S, Creanza V, Pompa G, Ciccone MM, Grandaliano G, Stallone G, Gesualdo L. Effects of low-sodium bread on dietary compliance and fecal cultivable bacteria in a randomized controlled pilot trial in hypertensive subjects. BMC Nutr. 2024 Feb 21;10(1):31. doi: 10.1186/s40795-024-00838-w. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low-sodium diet with low-sodium bread | Dietary Supplement | low-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months |
|
| Gut microbiota | Evaluation of gut microbiota modulation | 6 months |
| Antioxidant status | Evaluation of the antioxidant/oxidant ratio of blood | 6 months |
| Inflammation | State of sub-clinical inflammation | 6 months |
| Insulin sensitivity | Reduction of insulin sensitivity | 6 months |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |