Measuring Individual Responses to a Wholegrains and Nuts Intervention to Reduce Blood Pressure in Prehypertension (MI-DIET)

May 16, 2022 updated by: University of Aberdeen

Examining Factors Influencing Adherence to and Efficacy of a Wholegrains and Nuts Intervention to Reduce Blood Pressure in Prehypertension: a Series of N-of-1 Interventional Studies

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 number of baseline questionnaires to provide an overview of their typical eating and lifestyle-related behaviours, and general health. A second visit prior to the start of the study will then be arranged, where participants will undergo a semi-structured interview. Responses from the interview, in combination with their baseline questionnaire responses, will be used to identify factors specific to the participant that show some degree of variability. These will form the basis of the semi-personalised questionnaires delivered via the wrist-worn PRO-Diary device for the duration of the study. During the study, participants will visit the institute in a fasted state every 4 weeks (7 visits total), in order to provide a blood sample for assessment of cholesterol levels and for assessment of biomarkers of wholegrains intake. At the first visit, participants will receive the wireless blood pressure monitor and PRO-Diary wrist device programmed with twice-daily questionnaires at times convenient to the participant. After 2 weeks and every 4 weeks thereafter, participants will be sent a link by email to complete a 24-hour dietary recall. After 8 weeks, participants will begin the intervention phase and receive wholegrains equivalent to 3 portions a day and 1 portion of unsalted nuts per day for the following 8 weeks. Participants will be able to choose from a variety of wholegrain products commonly available at supermarkets. They will also receive dietary advice to follow a Dietary Approaches to Stop Hypertension (DASH) diet aimed at lowering blood pressure. All other measures will continue as previously. At week 16, the wholegrains and nuts will be withdrawn and participants will be followed up for a further 8 weeks. At their final visit to the institute, they will complete the same validated questionnaires as at baseline. Results from the study will be analysed using N-of-1 dynamic modelling to analyse trends over time and determine whether any personalised factors significantly affected adherence to intervention or blood pressure response.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZD
        • The Rowett Institute, University of Aberdeen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: N-of-1 study
For 24 weeks, each participant will measure their blood pressure and respond to questionnaires daily, and visit the institute to provide a blood sample every 4 weeks. The study is split into three 8-week phases, the first of which will start when each participant is enrolled. For the first 8-week observation phase (A1) the participant is instructed to continue with their usual diet and exercise habits. For the second 8-week intervention phase (B), the participant will be provided with wholegrains and nuts and recommended to substitute these in place of refined grains and other snacks, respectively. They will also receive dietary advice for following the Dietary Approaches to Stop Hypertension (DASH) diet. For the final 8 week follow-up period (A2), provision of wholegrains and nuts will cease but the participant will continue with measurements at the same frequency as previously.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence to wholegrains and nuts consumption
Time Frame: 8-week intervention period
Number of portions of wholegrains consumed and whether a portion of nuts were consumed, reported daily via the PRO-Diary wrist device.
8-week intervention period
Change in plasma alkylresorcinol levels reflecting wholegrains intake
Time Frame: Every 4 weeks from start of study up to 24 weeks
Concentration of alkylresorcinols as a measure of wholegrains intake in nmol/L
Every 4 weeks from start of study up to 24 weeks
Change in blood pressure
Time Frame: From start of study up to 24 weeks
Blood pressure (both systolic and diastolic) will be taken daily by participants via the QardioArm wireless blood pressure monitor. 3 measurements are taken automatically and averaged.
From start of study up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between adherence and blood pressure change
Time Frame: 8-week intervention period
Correlation between adherence and blood pressure change will be examined using N-of-1 dynamic modelling. Daily blood pressure measurements and PRO-Diary questionnaire responses will be provided during the whole study. Questionnaire responses will be given on a Visual Analogue Scale from 0-100.
8-week intervention period
Total, LDL and HDL cholesterol levels
Time Frame: 4-week blood samples
Fasted blood samples will be taken to determine whether wholegrains and nuts consumption has an effect on blood cholesterol levels.
4-week blood samples
Amount of wholegrains and nuts consumed during follow-up reported using PRO-Diary questionnaires
Time Frame: 8-week follow-up phase
For the final 8 weeks of the study, provision of wholegrains and nuts will cease but participants will continue to be asked about their consumption of these products through daily PRO-Diary questionnaires. This is to determine if habit formation has occurred and led to continuation of consumption of these products
8-week follow-up phase
Determination of personal factors which correlate with study outcomes using Ecological Momentary Assessment (EMA) through the PRO-Diary device
Time Frame: 24 weeks
Participants will respond to semi-personalised questionnaires daily using a Visual Analogue Scale from 0-100 using the PRO-Diary device. The PRO-Diary will also track movement collected during 60-second epochs via accelerometry. The influence of these factors on the primary and secondary outcomes above will be aggregated using N-of-1 dynamic modelling. Due to the semi-personalised nature of the questionnaires, the exact predictors examined in each N-of-1 study will differ. Analysis of each N-of-1 study will be conducted separately.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aberdeen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biotechnology and Biological Sciences Research Council
Unilever R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Baukje de Roos, The Rowett Institute, University of Aberdeen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MI-DIET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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