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

NCT04326686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-05-17

No results posted yet for this study

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 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.

Conditions

  • Prehypertension

Interventions

OTHER

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

30g mixed unsalted tree nuts (almonds, hazelnuts and almonds) per day; 3 portions of wholegrain foods per day (including wholegrain cereal products, wholegrain bread and wholegrain pasta); guidance for following the Dietary Approaches to Stop Hypertension (DASH) diet

Sponsors & Collaborators

  • Biotechnology and Biological Sciences Research Council

    collaborator OTHER

  • Unilever R&D

    collaborator INDUSTRY

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Baukje de Roos · The Rowett Institute, University of Aberdeen

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2022-03-25
Completion
2022-03-25

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326686 on ClinicalTrials.gov