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ID
Source
Brief title
Health condition
hypertention
Sponsors and support
Intervention
Outcome measures
Primary outcome
24h blood pressure
Secondary outcome
- Plasma concentrations: plasma nitrate and nitrate, plasma cholesterol, HDL, LDL, triglyceride, troponin I;
- Dietary intake: total macro- and micronutrient intake, vegetable and dietary nitrate intake;
- Blood pressure and heart rate at rest, during submaximal exercise and orthostatic resonse
- Exhaled nitric oxide;
Background summary
Rationale: Green leafy vegetables (e.g., spinach, rocket salad/arugula, lettuce) and beetroot share the common characteristic of high nitrate content. Recently, there has been an increased interest in the role of dietary nitrate as a biologically active nitric oxide (NO) donor, due to its proposed beneficial effects on cardiovascular health. Therefore, food based ways of increasing nitrate intake through the diet appear to form a worthwhile strategy to induce cardio protective effects. However, there is a lack of knowledge on the effects of a prolonged elevation of nitrate intake via the habitual diet.
Objective: The main aim of the current study is to investigate the effect of a 12 week dietary intervention focusing on increasing dietary nitrate intake on 24h blood pressure. Besides, we want to investigate the effects on:
- Plasma concentrations: plasma nitrate and nitrate, plasma cholesterol, HDL, LDL, triglyceride, troponin I;
- Dietary intake: total macro- and micronutrient intake, vegetable and dietary nitrate intake;
- Blood pressure and heart rate at rest, during submaximal exercise and orthostatic resonse
- Exhaled nitric oxide;
Study design: The present study will use a randomized, controlled, parallel study design
Study population: 87 (pre)hypertensive males and females, registered to participate in the Nijmegen Four Days Marches 2019.
Intervention: 12 weeks of educational intervention with intense (weekly) personalized monitoring and feedback focusing on nitrate rich vegetables (intervention group), dietary nitrate supplementation (supplementation group) or no intervention (control group).
Main study parameters/endpoints: The primary outcome is the change in 24h blood pressure after 12 weeks intervention, which will be compared between the intervention, supplementation and control group. Furthermore, blood pressure and heart rate responses during exercise and orthostasis will be assessed before, after 12 weeks and during the Four Days Marches.
Study objective
-
Study design
before and after
Intervention
dietary counseling focussing on nitrate rich vegetables, beetrootjuice supplementation and control
Inclusion criteria
- Prehypertension or hypertension:
Prehypertension is a systolic and/or diastolic pressure above 131/86 – 139/89 mmHg. Hypertension is a systolic and/or diastolic pressure above 140/90mmHg [22]. When one of the two is equal to or higher than 131-86, the participant will be included.
- Current vegetable intake <200 g/d based on FFQ;
- Registered for the Nijmegen Four Days Marches 2019;
- 18.5 < BMI ≤ 35.0 kg/m2;
- Able to understand and perform the study procedures.
Exclusion criteria
- Chronic use of medication or products with known vasoactive properties and chronic use of the following products: [63, 64];
NSAIDs (including acetylsalicylic acid and selective COX-2 inhibitors)
sympathomimetics (decongestants, sibutramine, cocaine)
Alcohol
glycyrretic acid-containing products (including licorice, liquorice and some chewing gums)
erythropoietin
cyclosporine
timulants ((dex) methylphenidate, (dextroof with) amphetamine, modafinil)
some herbs (ephedra, ma huang)
- Currently smoking [23];
- Currently supplementing diet with nitrate.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7814 |
| CCMO | NL68764.072.19 |
| OMON | NL-OMON48183 |