Status:
COMPLETED
Measuring Individual Responses to a Wholegrains and Nuts Intervention to Reduce Blood Pressure in Prehypertension
Lead Sponsor:
University of Aberdeen
Collaborating Sponsors:
Biotechnology and Biological Sciences Research Council
Unilever R&D
Conditions:
Prehypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of the study is to investigate whether physiological, psychological and environmental factors, at an individual level, modify a) adherence, and b) blood pressure response, to a nuts and wholeg...
Detailed Description
The study will be conducted as an interventional N-of-1 study with an A1-B-A2 design of 8 weeks per study period. Prior to the study, participants will be screened and if eligible, will complete a num...
Eligibility Criteria
Inclusion
- Mildly elevated blood pressure levels: systolic blood pressure (SBP) \>120 \<=140mmHg and/or diastolic blood pressure (DBP) \>80 \<=90mmHg.
- Low habitual intake of wholegrains: \<=7 portions/week
- Body Mass Index (BMI) between 18-35
- Possessing a smartphone capable of running the Qardio app in conjunction with the QardioArm wireless blood pressure monitor
Exclusion
- SBP \<120 or \>140mmHg or DBP \<80 or \>90mmHg. Participants with SBP \> 140 or DBP \> 90 will be advised to visit their GP to have their blood pressure reassessed in a clinical setting.
- Diagnosed with diabetes
- Clinically diagnosed with hypertension or hypercholesterolemia
- Unstable or untreated thyroid disorder
- Taking blood pressure- or cholesterol-lowering medications (e.g. beta blockers or statins)
- Following a low carbohydrate/gluten free diet
- Coeliac disease/gluten insensitivity
- Any food allergies
- Being on a weight loss diet or having lost \>5kg in the last 6 months
- Any history of an eating disorder
- \>7 portions/week habitual wholegrains consumption
- Having taken part in a study where wholegrains were provided in the last 3 months
- Not possessing a smartphone to run the Qardio app.
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04326686
Start Date
October 30 2020
End Date
March 25 2022
Last Update
May 17 2022
Active Locations (1)
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1
The Rowett Institute, University of Aberdeen
Aberdeen, Aberdeen City, United Kingdom, AB25 2ZD