Effects of wholegrain-derived compounds supplementation on blood vessel stiffness

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Recruitment status:
Recruiting
Primary Sponsor:
The University of Aberdeen
Recruitment countries:
United Kingdom
Health condition studied:
Blood pressure
Circulatory System
Blood pressure
URL:
Link to the clinical trial website

About the trial

Interventions:
Participants receive the intervention and control treatment in a random order, which are delivered at separate study visits (2-4 weeks apart). Before the study visit, participants are asked to refrain from eating any wholegrain foods, beans, pre- or probiotics as well as foods high in dietary fibre for at least three days. At baseline, participants have a 5ml sample of blood taken, a 24 hour blood pressure monitor fitted to their other arm and their blood vessel stiffness measured.

Intervention: Participants will be given breakfast which includes a 150ml drink containing 3g calcium propionate.

Control: Participants will be given breakfast which includes an identical 150ml drink which does not contain calcium propionate.

In each condition, blood samples are take 15 minutes, 30 minutes, 1 hour and 3 hours after ingesting the drink. Blood vessel stiffness is measured at the same timepoints. Participants return the following morning for another blood test and blood vessel stiffness measurement. The 24 hour blood pressure monitor is also removed at this point.
Key inclusion and exclusion criteria:
  • Inclusion criteria: 1. Male
    2. Aged 40-65 years old
    3. 115mmHg = systolic blood pressure =159mmHg & 70mmHg = diastolic blood pressure = 99mmHg
    4. BMI between 19 and 30 kg/m2
  • Exclusion criteria: 1. BMI under 19 kg/m2 or over 30kg/m2
    2. Systolic blood pressure >159mmHg or <115mmHg & diastolic blood pressure
    3. Any pharmalogical treatment for hypertension or depression
    4. Suffering from eating disorders and/or taking any nutritional supplements , and/or usually eating high intake of wholegrains or probiotics
  • Age minimum: 
  • Age maximum: 
  • Gender:  Male
Primary outcomes:
Arterial function as measured by pulse wave analysis
Secondary outcomes:
1. Blood pressure is measured using the 24 hour blood pressure monitor over the 24 hours following each of the two study visits
2. Systemic markers of endothelial function
3. Blood pressure regulation
Target sample size:
25
Study type:
Interventional
Study design:
Single-centre double-blind cross-over randomized controlled trial (Other)
Contacts:
  • Name: Frank Thies
  • Address:  The University of Aberdeen Foresterhill
  • Phone:  +44 1224 437954
  • Email:  f.thies@abdn.ac.uk
  • Affiliation: 
  • Name: Karolin Muzs
  • Address:  The University of Aberdeen Foresterhill
  • Phone:  +44 1224 438758
  • Email:  karolin.muzs@abdn.ac.uk
  • Affiliation: 

Technical details

Scientific title:
The effects of short chain fatty acid supplementation on vascular function in middle-aged volunteers
Sources of monetary support:
Scottish Government
Secondary sponsors:
Main ID:
ISRCTN11698069
Secondary ID:
N/A
Register:
ISRCTN
Date of registration:
04/04/2016
Date of first enrollment:
14/01/2016
Last refreshed:
17 October 2016

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