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Dietary proteins and blood pressure-related mechanisms.


- candidate number8747
- NTR NumberNTR2678
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-dec-2010
- Secondary IDsNL34527.068.10 / 10-3-075 ; CCMO / METC
- Public TitleDietary proteins and blood pressure-related mechanisms.
- Scientific TitleAcute effects of dietary proteins, which differ in amino acid composition, on blood pressure-related mechanisms.
- ACRONYMAAPRES
- hypothesisDifferent dietary proteins have a different effect on blood pressure-related mechanisms.
- Healt Condition(s) or Problem(s) studiedHypertension, High blood pressure, Proteins
- Inclusion criteria1. Men and women;
2. BMI 25-35 kg/m2;
3. High normal BP or untreated grade 1 hypertension (SBP 130-159 mm Hg and/or DBP 85-99 mm Hg);
4. Age between 20 - 70 years;
5. No smoking;
6. Stable weight in last 3 months (+/- 2 kg).
- Exclusion criteria1. Presence of urinary protein;
2. eGFR < 60 ml/min/1.73 m2;
3. Fasting glucose > 7 mmol/l;
4. Use of prescription medication that could influence BP or vascular function;
5. Gastrointestinal, cardiovascular, pulmonary, liver or renal disease;
6. Food allergies, a special diet or vegetarian;
7. Unwillingness to stop use of vitamin or dietary supplements.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate16-dec-2011
- Target number of participants50
- InterventionsFirst 2 weeks weight maintaining standardized diet (15 en% protein, 30 en% fat and 55 en% carbohydrates). Next 6 weeks weekly clinical investigation days on which the acute postprandial effects of different types of protein supplements and different types of carbohydrate supplements will be investigated.
- Primary outcomeAcute TPR response (derived according to the equation; MAP = CO x TPR) on each clinical investigation day during first 4 hours after consumption of supplements. Mean Arterial Pressure (MAP) and Cardiac Output (CO) will be measured.
- Secondary outcomeAcute responses on renal sodium excretion, vasodilating factors and vascular function changes on each clinical investigation day during first four hours after consumption of supplements.
- Timepoints6 clinical investigation days with 1 week wash-out on which every hour postprandial measurements will be performed.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. J. Dopheide
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.A. Baak, van
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
TI Food and Nutrition
- PublicationsN/A
- Brief summaryAAPRES is a human intervention study with a randomized crossover design that investigates the acute effects of several dietary proteins on blood pressure-related mechanisms.
- Main changes (audit trail)
- RECORD7-dec-2010 - 21-jan-2011


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