NCT04326686: MI-DIET

Measuring Individual Responses to a Wholegrains and Nuts Intervention to Reduce Blood Pressure in Prehypertension

Completed NA Last updated 17 May 2022

What this trial tests

NA trial testing Dietary intervention: nuts and wholegrains with dietary advice for a blood-pressure lowering diet in Prehypertension in 12 participants. Completed in 25 March 2022.

Timeline

30 October 2020

Primary endpoint
25 March 2022

25 March 2022

Quick facts

Lead sponsor	University of Aberdeen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	12
Start date	30 October 2020
Primary completion	25 March 2022
Estimated completion	25 March 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Dietary intervention: nuts and wholegrains with dietary advice for a blood-pressure lowering diet

Conditions studied

• Prehypertension — all drugs for Prehypertension →

Sponsor

University of Aberdeen

Who can join

Adults 18 to 75, any sex, with Prehypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 wholegrains intervention in participants at risk for developing high blood pressure. For 24 weeks, participants will, on a daily basis, monitor their own blood pressure using a wireless blood pressure monitor and respond to short semi-personalised questionnaires using a wrist-worn device, which also measures activity levels. Participants will receive an intervention of wholegrain foods and nuts to substitute into their diets for 8 weeks, between two 8-week observation periods. The length of the study periods will enable repeated measurements to be taken, in order to assess what factors, on an individual level, are associated with fluctuations in the outcomes. This will provide an insight into the types of factors that can help to explain individual fluctuations in adherence and physiological outcomes, such as blood pressure, that are common in nutrition studies. In the future, this should help in tailoring the way the investigators deliver effective individualised interventions, and enable researchers to be better able to consider and control for factors that can affect adherence and response to dietary interventions.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perspective: Application of N-of-1 Methods in Personalized Nutrition Research.
   Potter T, Vieira R, de Roos B. · · 2021 · cited 27× · PMID 33460438 · DOI 10.1093/advances/nmaa173
2. A series of N-of-1 dietary intervention studies with whole-grain foods and nuts reveals individual predictors of blood pressure and heart rate.
   Potter TIT, Pepping F, Wanders AJ, Zandstra EH, et al · · 2026 · PMID 42049896 · DOI 10.1038/s41430-026-01740-3