Impact of diet plus exercise on endothelial function, arterial stiffness and blood pressure in stage 1 hypertensive patients: results from the ?INTreat randomized, open-label trial

?INTreat

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200307046715N1

Enrollment

Registered

2020-03-14

Start date

2637-04-21

Completion date

Unknown

Last updated

2020-03-24

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

Conditions

Hypertension. Essential (primary) hypertension

Interventions

Intervention 1: Intervention group: receiving intensive lifestyle treatment concerning nutrition modification and exercise, in accordance with the ESH guidelines. In further detail, at baseline, the i

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Untreated stage 1 hypertensive Adults Agreed to participate

Exclusion criteria

Exclusion criteria: Diagnosis of secondary hypertension Diabetes Mellitus Cardiovascular Diseases Any known inflammatory condition Malignancy Other significant comorbidities affecting blood pressure Treatment with anti hypertensive agents or other significant medication including diuretics

Design outcomes

Primary

Measure	Time frame
Blood pressure. Timepoint: baseline, 3 months, 6 months. Method of measurement: sphygmomanometer.;Carotid intima-media thickness. Timepoint: baseline, 6 months. Method of measurement: ultrasound.;Carotid stiffness. Timepoint: baseline, 6 months. Method of measurement: ultrasound.;Pulse wave velocity. Timepoint: baseline, 6 months. Method of measurement: ABPM, Mobil-O-Graph.;Lipid profile (Total Cholesterol, TG, HDL, LDL). Timepoint: baseline, 6 months. Method of measurement: Fasting blood sample.	—

Measure

Time frame

Blood pressure. Timepoint: baseline, 3 months, 6 months. Method of measurement: sphygmomanometer.;Carotid intima-media thickness. Timepoint: baseline, 6 months. Method of measurement: ultrasound.;Carotid stiffness. Timepoint: baseline, 6 months. Method of measurement: ultrasound.;Pulse wave velocity. Timepoint: baseline, 6 months. Method of measurement: ABPM, Mobil-O-Graph.;Lipid profile (Total Cholesterol, TG, HDL, LDL). Timepoint: baseline, 6 months. Method of measurement: Fasting blood sample.

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Secondary

Measure	Time frame
Anthropometry changes (body weight, waist & hip circumference, body synthesis). Timepoint: baseline, 6 months. For body weight and circumferences also at 3 months. Method of measurement: weight scale, measuring tape, bioelectrical impedance.;Physical activity level. Timepoint: baseline, 6 months. Method of measurement: IPAQ, pedometer.;Diet changes. Timepoint: baseline, 6 months. 24 hour recall used at 3 months. Method of measurement: (3day recall, 24hour recall, MedDiet score, DII score, salt score).;Urinary losses in sodium, potassium, creatinine, microalbumin. Timepoint: baseline, 3 & 6 months. Method of measurement: 24h urinary sample analysis.;Resting energy expenditure. Timepoint: baseline, 6 months. Method of measurement: Indirect calorimetry (Breezing).	—

Measure

Time frame

Anthropometry changes (body weight, waist & hip circumference, body synthesis). Timepoint: baseline, 6 months. For body weight and circumferences also at 3 months. Method of measurement: weight scale, measuring tape, bioelectrical impedance.;Physical activity level. Timepoint: baseline, 6 months. Method of measurement: IPAQ, pedometer.;Diet changes. Timepoint: baseline, 6 months. 24 hour recall used at 3 months. Method of measurement: (3day recall, 24hour recall, MedDiet score, DII score, salt score).;Urinary losses in sodium, potassium, creatinine, microalbumin. Timepoint: baseline, 3 & 6 months. Method of measurement: 24h urinary sample analysis.;Resting energy expenditure. Timepoint: baseline, 6 months. Method of measurement: Indirect calorimetry (Breezing).

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Countries

Greece

Contacts

Public ContactAnastasios Vamvakis

aristotle university of thessaloniki

tvamvakis@yahoogr+30 231 022 7623

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026