Effect of a functional bread on blood pressure, glucose metabolism and endothelial function

Effect of functional bread reduced in salt and fermented with dough containing lactobacillus brevis forming gamma-aminobutyric acid, on blood pressure, glucose metabolism and endothelial function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31436822

Enrollment

Registered

2013-05-20

Start date

2013-03-06

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-hypertension Circulatory System Hypertension

Interventions

1. Healthy dietary recommendations + traditional bread 2. Healthy dietary recommendations + bread reduced in sodium chloride 3. Healthy dietary recommendations + bread reduced in sodium chloride ferme

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients (male and female) aged between 18 and 65 years with pre-hypertension but without antihypertensive medication

Exclusion criteria

Exclusion criteria: 1. Severe hypertension (systolic blood pressure = 160 mmHg, diastolic blood pressure = 100 mmHg) 2. Type 2 diabetes 3. Body mass index (BMI) >35 kg/m^2 4. Target organ injuries attributed to hypertension 5. Inflammatory or infectious disease 6. Anti-inflammatory or antibiotic drugs 7. Alcoholism or drug abuse 8. Recent hypocaloric diet

Design outcomes

Primary

Measure	Time frame
Daily mean blood pressure measured by a 24 hour continuous register at baseline and at the end of each intervention period (after one month).	—

Secondary

Measure	Time frame
1. Blood pressure during activity and sleeping period 2. Blood pressure during the three hours after consuming the bread at morning. 3. Fasting glycemia, insulinemia and Homeostatic Measurement Assessment-Insulin Resistance (HOMA-IR) 4. Endothelial function and peripheral inflammation measured by biochemical markers. 5. Endothelial function measured by the Endo-PAT method 6. Adherence to the intervention 7. Tolerance and safety Measured at baseline and at the end of each intervention period (after one month)	—

Measure

Time frame

1. Blood pressure during activity and sleeping period 2. Blood pressure during the three hours after consuming the bread at morning. 3. Fasting glycemia, insulinemia and Homeostatic Measurement Assessment-Insulin Resistance (HOMA-IR) 4. Endothelial function and peripheral inflammation measured by biochemical markers. 5. Endothelial function measured by the Endo-PAT method 6. Adherence to the intervention 7. Tolerance and safety Measured at baseline and at the end of each intervention period (after one month)

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026