Obesity Prevention in Children and Young People Treated for Acute Lymphoblastic Leukaemia with ALLTogether (BREVARY)

February 22, 2025 updated by: Raquel Revuelta Iniesta, University of Exeter

OBesity PREVention in Children and Young People Treated with ALLtogetheR: Prehabilitation Feasibility Intervention

Background Leukaemia is the most common cancer in children with 800 diagnoses per year in England. To survive, children need strong treatments like chemotherapy and steroids given usually through clinical trials. The current trial used by the NHS is called ALLTogether. Fifty percent of children become obese during treatment due to increased hunger, cravings for junk foods and lack of physical activity. Obesity raises the chance of cancer relapse by 31%, makes treatment side-effects worse and makes it harder to kill off leukaemia cells, which affects how well children do during treatment, as indicated by minimal residual disease, a key predictor of prognosis.

Aims and Objectives This study (called BREVARY) aims to see if we can successfully provide personalised diet and physical activity with behaviour support for children and young people with leukaemia who are being treated with the ALLTogether trial. It will help us figure out if we can perform a bigger study, if this programme could reduce obesity and side-effects and improve survival and wellbeing.

How it will be done We plan to randomly assign participants to one of three groups; one group will get both a diet and physical activity plan, another will get only a diet plan, and the last group will receive standard care. This will take place in Hospital Infantil Universitario Nino Jesus, Madrid and Bristol Royal Hospital for Children and Southwest England NHS-sites. The diet and exercise plans will be created in partnership with the children and their families and delivered online or during regular hospital visits. The diet will follow healthy eating guidelines, consider personal food preferences (including cultural and religious needs), treatment side-effects and personal finances. Assessments of fitness and strength will be taken to plan personalised activities. During the study, the following data will also be collected: weight, height, body fat, diet, biomarkers, microbiome, muscle strength and wellbeing at three different times. "One to one" interviews will be conducted at the end to obtain feedback on their experiences with BREVARY.

This study aims to find out if children and their families/carers are willing to participate in BREVARY, if enough people sign up and stay until the end and if our interventions and health measurements are appropriate.

Potential Impact The results will help determine if a larger study can be performed, if changes are needed and what the cost will be. The study will be disseminated through networks, targeting underserved communities, healthcare professionals and affected families using accessible platforms to spread the word.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The international randomised controlled trial registry shows that no lifestyle intervention (diet, physical activity with integrated counselling) has been performed in the UK. The IDEAL trial performed in the USA demonstrated that diet with energy intake restriction and physical activity was feasible and significantly improved Minimal Residual Disease (MRD) in children diagnosed with Acute lymphoblastic leukaemia (CYP_ALL) and treated with National Cancer Institute/Rome high-risk B-ALL protocol during induction. ALLTogether is similar and will for the first time provide an excellent platform to prevent obesity in CYP_ALL.

Obesity associated relapse is attributed to adipocyte-mediated chemo-resistance, which occurs in CYP_ALL with higher fat mass and leads to more persistent MRD. MRD is a marker of leukaemic cells and the strongest predictor of prognosis including both remission and relapse. Therefore, obesity is identified as a prognostic factor for relapse (measured by MRD) and it is associated with increased morbidity and mortality, and poorer wellbeing.

Only two dietary feasibility interventions have investigated CYP_ALL differing in the type (diet alone vs. diet and physical activity) and the length of intervention (1 - 6 months). Both showed improvements in diet quality, high participation (>70%) and 56 - 82% adherence. Indeed, the IDEAL trial also showed improvements in MRD and body composition, making it suitable to base BREVARY's design. Consensus exists regarding using patient-centre interventions in clinical settings; like the Individualised Macronutrient Meal-Equivalent Menu (Menus). This approach reduces food associated stress, anxiety and financial costs, while empowering patients and their families/carers, thus improving adherence. It has been shown to be successful in adults with breast cancer and provides a validated approach to CYP_ALL.

A systematic review showed that individualised physical activity combining fitness and strength mitigated complications in CYP_ALL. However, it was difficult to draw firm conclusions because evidence were limited by sample sizes, adherence was seldom reported and study designs were heterogenous differing in length (1 - 30 months), exercise type and intensity and assessed outcomes (e.g. cardiorespiratory fitness, strength and wellbeing). Six trials are underway including all cancers with interventions being either individualised ("as able" and play-based exercise for children aged <5 years) or employing generic exercise prescriptions with intensity "as able". They are investigating fitness, strength and wellbeing; however, none have incorporated dietary assessment or intervention.

4. Research proposal

Aim

Investigate the feasibility of conducting a randomised controlled trial (RCT) to prevent obesity in CYP_ALL and treated with ALLTogether.

The hypothesis is that BREVARY will reduce obesity rates, improve clinical outcomes by reducing side-effects and relapse and improving CYP_ALL and their families/carers' quality of life. BREVARY will establish if a multi-site RCT is feasible and acceptable to families and clinical teams, examine recruitment and data collection strategies, and assess candidate outcomes.

BREVARY comprises three workstreams (WS):

WS1: Implementing a RCT of BREVARY for 3 months involving newly diagnosed CYP_ALL treated with ALLTogether in SW England NHS-sites and Hospital Infantil Universitario Nino Jesus Madrid WS2: Process evaluation of BREVARY RCT examining feasibility and maintenance of intervention (3 months intervention, maintenance at 6 months) WS3: Assessment of feasibility of progression to a definitive trial, including setting trial parameters

Objectives

  • Assess recruitment, including acceptability of randomisation to stakeholders, across ethnically, geographically and socially diverse communities (WS1)
  • Assess interventions acceptability and retention (WS1/WS2)
  • Assess feasibility and appropriateness of quantitative and qualitative outcomes (WS1)
  • Assess RCT resource implications of interventions and potential service use savings (WS1/WS3)
  • Assess fidelity and adherence to protocol within interventions and control groups (WS1/WS2)
  • Assess feasibility of progression to a definitive trial, set out main parameters and estimate both sample size and cost of a RCT (WS3)

Project plan

WS1: Implementing BREVARY

Study design BREVARY is phase 2 of Medical Research Council framework for complex interventions. Development and identification of the complex intervention (phase 1) was performed based on the IDEAL pilot-trial. BREVARY was designed in consultation with NIHR Nutrition and Cancer and PPI, reviewed by NIHR RSS and is supported by ALLTogether sponsors (UK and Spain).

Feasibility three-arm non-blinded parallel RCT with integrated quantitative and qualitative measures. Quantitative measures will be performed at baseline, end of induction (4 - 6 weeks) and during consolidation treatment (3 months weeks) and a follow up at 6 months. Qualitative measures will be performed at the end of BREVARY in a sample subgroup. The three-arms include combined diet and physical activity, diet only and standard care.

Recruitment Recruitment will be conducted by researchers. Inclusion criteria

  • CYP aged between 2 - 21 years.
  • Newly diagnosed and relapse CYP_ALL treated in University Hospital Bristol and Weston NHS Foundation Trust and Hospital Infantil Universitario Nino Jesus, Madrid
  • Within two weeks of being recruited to ALLTogether.
  • Treated with curative intent. Exclusion criteria
  • CYP not partaking in ALLTogether.
  • CYP treated with palliative intent.
  • Those excluded by NHS-staff for clinical reasons. BREVARY aims to recruit 10 - 15 in each arm and each international centre (n= 60 - 90 in SW England and Madrid; 50% recruitment rate, which is below previous studies and the IDEAL trial to test feasibility and to calculate the variability of reliable estimates of continuous variables.

Eligible participants will be randomised using computer-generated restricted (nutritional status, age and sex) randomisation procedure in 1:1:1 ratio.

BREVARY Intervention (table 1)

Twenty % energy deficit and equicaloric intervention will be applied to those classified as overweight/obese and healthy weight respectively by diet (- 20%).

Researchers will deliver weekly one-to-one supervised sessions during induction and fortnightly during consolidation (total 8 sessions) online/home or at routine appointments. Physical activity intervention will include two additional sessions supervised non-consecutive sessions as tolerated. Both designed following PPI preferences.

Dietary intervention Menus based on Eatwell guide in the UK and Food and Agriculture Organisation in Spain will be used. Menus consists of prescribing 7 interchangeable meal options matched in energy and macronutrients requirements to reduce participants meal planning burden. It accounts for side-effects, psycho-social factors and religious, cultural, personal (and PPI) preferences. Nutritics® will be used to create Menus and estimate nutrients.

CYP_ALL referred to Dietetics will receive the intervention post-Dietetic discharged to avoid interference with nutritional support.

Physical activity intervention Individualised plans will be prescribed based on fitness and clinical condition. The programme will start at enrolment unless contraindicated. Sessions will include a combination of aerobic, balance and resistance exercise based on individual fitness and strength, age and clinical history as well as individual preferences and available equipment.

Standard care CYP_ALL will receive usual care (described in "The problem"). Counselling sessions for CYP_ALL and families/carers (all groups) Counselling sessions were requested by PPI and are recommended for motivation and adherence in long-term clinical interventions.

Two online/home (or at routine appointments) one-to-one sessions will be delivered. Sessions will be designed by all co-applicants, reviewed by our clinical psychologist and delivered by the researchers with PPI CoA support and focusing on:

(i) Diet and physical activity benefits (ii) Behaviour and autonomy (iii) Difficulties encountered and how to address them (iv) Motivation Data collection (all groups)

  • Eligible CYP_ALL
  • Eligible CYP_ALL approached to participate
  • Families declining intervention before randomisation, after randomisation and after the first set of measurements (before follow-ups)
  • Families allocated to interventions dropping out between second and final follow-up
  • Families allocated to standard care dropping out between second and final follow-up

Health Electronic Records (HER) will be accessed to collect demographics (CYP_ALL sex, ethnicity and age), socio-economics (parents' relationship status, siblings, employment status, education level, income and housing status), clinical (diagnosis, treatments, side-effects, hospital admissions), routine biomarkers (MRD, immunoglobulins, full blood count, total cholesterol, high density lipoprotein and low density lipoprotein and glucose) and other biomarkers (leptin and adiponectin) and stool samples (microbiome). Participants' postcodes will be linked to the Indices of Multiple Deprivation.

Based on the IDEAL trial, feasibility and acceptability and PPI feedback, the following outcome measures will be taken at baseline, 4 - 6 weeks, 3 months and a follow up at 6 months (to assess intervention sustainability - no intervention from 3 - 6 months).

  • Weight, height and body composition (Multi-frequency Bio-electrical Impedance)
  • Dietary intake using a multiple-pass 24 hour recall
  • Seven days physical activity levels at each follow up using GENEActiv accelerometers, strength by hand-held hydraulic dynamometer and fitness by 15-foot walk (excluding children aged <5y).
  • CYP_ALL and their families/carers' QoL will be assessed at baseline and at completion using two validated questionnaires PedQL-Cancer and Parents PedQL-Cancer.

We will determine primary and secondary candidate outcome measures for future trial based on performance of selected measures.

Candidate primary outcome measures for definitive trial

  • Body mass index Z-score (≤ 19 years)
  • Muscle and fat mass percentage
  • MRD
  • Quality of Life: PedQL-Cancer and Parents PedQL-Cancer Candidate secondary outcome measures for definitive trial
  • Biomarkers and Microbiome
  • Food group indicators and nutrient intake
  • Physical activity levels
  • Hand strength (percentiles 5 ≤ 18 years)
  • CPET - Fitness excluding children aged < 5 years
  • Clinical outcomes, number and type of treatment side-effects and intervention side-effects
  • Hospital admissions
  • Changes in treatment regime (ALLTogether)
  • Microbiome: composition and diversity of microbiome

Analysis CONSORT flow diagram will be used to report participant flow and descriptive statistics for demographics, clinical and socio-economic data with overall data and stratified by arm. Appropriate distribution or frequencies will be used (count/percentages, mean/SD and median/IQR). IBM_SPSS statistics® will be used for analysis and a Statistical Analysis Plan will be signed-off prior to any analysis taking place.

WS2: Process evaluation The process evaluation assesses how implementation of BREVARY is achieved, influenced by contextual factors including randomisation and trial design, and quality of implementation and acceptability. The following stakeholders will be included: Parents/carers whose CYP_ALL partake in BREVARY, CYP_ALL able to understand the questions and communicate an answer and researchers plus NHS-staff directly involved in implementing BREVARY. RE-AIM (http://www.re-aim.org/) based on reach, effectiveness, adoption, implementation and maintenance will be used.

Semi-structured one-to-one online (or at routine appointment) interviews will be conducted to a subgroup (n = 15) with equal representation from each arm to explore enjoyment:

  • Best and worst things about partaking
  • Overall satisfaction
  • Likelihood to recommend BREVARY
  • Reasons for dropping out Facilitator records will be completed by the researchers using structured case-records to collect RE-AIM

Analysis Quantitative survey data will be analysed using descriptive statistics. Free text responses will be analysed using thematic analysis and audio recordings will be transcribed, anonymised and data analysed using thematic analysis in Nvivo®.

Fidelity: Intervention delivery (usage statistics), receipt (usage statistics and interviews) and enactment (interviews, questionnaires and measurements) as well as repeated engagement (usage statistics and counselling sessions) will be conducted separately. Findings will be integrated following a triangulation protocol to assess whether data agree (convergence), complement one another (complementary), or contradict each other (dissonance).

WS3: Progression criteria and definitive RCT design

Results from WS1 and WS2 will be reviewed by all co-applicants. A trial will be regarded feasible if the following criteria are met:

Progression criteria and definitive RCT design

  • Recruitment rate ≥ 50%
  • ≥ 70% of recruited families complete the trial in one of the intervention groups
  • ≥ 70% of families, researchers and clinical staff agree that the intervention is acceptable (RE-AIM)
  • Recruited participants complete ≥ 60% of the supervised sessions (RE-AIM)
  • ≥ 70% of families agree that the intervention is enjoyable

Health economics Within-trial economic and resource use analysis based on complex intervention protocols will be used. This reduces participants' burden and meets PPI feedback.

The within-trial analysis will investigate the cost-effectiveness of each arm. The primary within-trial analysis used in the full trial will be a cost-utility-analysis (CUA), which estimates the incremental cost per quality adjusted life (QALY) of each arm. QALY will be generated via measurement of utility values using PedsQL-cancer and Parents PedQL-Cancer instrument mapped to the EQ-5D.

The resource use analysis will be estimated using HER. Data (e.g. admissions, medication) will be collected by researchers. A cost-consequences framework will be used to describe resources used and benefits gained from the intervention without developing a full cost-effectiveness estimate.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • 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 Contact

Study Contact Backup

Study Locations

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • CYP aged between 5 - 21 years.
  • Newly diagnosed or relapsed CYP_ALL treated in University Hospital Bristol and Weston NHS Foundation Trust and Hospital Infantil Universitario Nino Jesus, Madrid
  • Within two weeks of being recruited to ALLTogether.
  • Treated with curative intent.

Exclusion Criteria:

  • CYP not partaking in ALLTogether.
  • CYP treated with palliative intent.
  • Those excluded by healthcare professionals or clinical reasons

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diet
Individualised Dietary Intervention
Behavioral: Diet
Individualised dietary intervention
Experimental: Diet and Physical Activity
Individualised Dietary and Physical Activity Intervention
Behavioral: Diet and physical activity
Obesity prevention: Diet, Diet and physical activity and standard care
No Intervention: Standard Care
No intervention - this is standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal Residual Disease
Time Frame: initial assessment, day 29, day 50 and day 78
Candidate Primary Outcome (feasibility study). Hospital own's laboratory assay
initial assessment, day 29, day 50 and day 78
Muscle and fat mass
Time Frame: Initial assessment, at 29 days, at 3 months, at 6 months
Candidate primary outcome, Multifrequency BIA FFM and FM percentage Impedance Reactant
Initial assessment, at 29 days, at 3 months, at 6 months
Body Mass Index Z score
Time Frame: initial assessment, at day 29, at 3 months and at 6 months

Candidate Primary Outcome Calculated from weight and height (weight/height^2) WHO BMI Z score (scale score) Z-Score Range Nutritional Status < -3 SD: Severe undernutrition (Severely underweight, stunted, or wasted)

  • -3 SD and < -2 SD: Moderate undernutrition (Underweight, stunted, or wasted)

  • -2 SD and ≤ +1 SD: Healthy weight (Normal nutritional status)

    • +1 SD and ≤ +2 SD: Overweight
    • +2 SD: Obese
initial assessment, at day 29, at 3 months and at 6 months
Quality of Life
Time Frame: initial assessment, at 3 months and at 6 months

Candidate Primary outcome (Quality of Life: PedQL-Cancer Module questionnaire) The PedsQL-Cancer Module includes multiple subscales that address specific areas of functioning and challenges related to cancer, such as: Pain and hurt, Nausea, Procedural anxiety, Treatment anxiety, Worry, Cognitive problems, Perceived physical appearance, Communication.

To calculate scores, the items are reverse scored and linearly transformed to a Original Response Reverse Score (Transformed Score) 0 = Never 100

  1. = Almost Never 75
  2. = Sometimes 50
  3. = Often 25
  4. = Almost Always 0

Scores are reverse, thus higher scores indicate better health-related quality of life or fewer reported problems.

Mean scores are calculated for each subscale by summing the item scores and dividing by the number of items answered. If more than 50% of the items in a subscale are missing, the subscale score is not computed.
initial assessment, at 3 months and at 6 months
Parent's quality of life
Time Frame: Initial assessment, at 3 months and at 6 months

Parents PedQL-Cancer he PedsQL Cancer Module - Parent Proxy Report is a specialized tool designed to assess health-related quality of life (HRQoL) in children and adolescents with cancer, based on the parent's perception.

The Parent PedsQL Cancer Module includes the following subscales tailored to cancer-related challenges: Pain and Hurt, Nausea, Procedural Anxiety, Treatment Anxiety, Worry, Cognitive Problems, Perceived Physical Appearance, Communication To calculate scores, the items are reverse scored and linearly transformed to a 0-100 scale: 0 = 100; 1 = 75; 2 = 50; 3 = 25; 4 = 0 Higher scores indicate better health-related quality of life or fewer reported problems.
Initial assessment, at 3 months and at 6 months
Feasibility: Participation rate
Time Frame: Baseline, time 0
The proportion of the target population that actually participates in the intervention measured in frequencies
Baseline, time 0
Feasibility: Representativeness
Time Frame: At 0, day 29, 3 months and 6 months

The degree to which the participants reflect the broader population intended to benefit from the intervention.

Outcome measure in percentages
At 0, day 29, 3 months and 6 months
Feasibility: Accessibility
Time Frame: At 0, day 29, 3 months and 6 months

Evaluates whether the intervention is accessible to all segments of the target population, including those who are typically underrepresented.

Outcome measure in percentage
At 0, day 29, 3 months and 6 months
Feasibility: Barriers to participation
Time Frame: At 0, day 29, 3 months and 6 months

Identifies factors that prevent individuals from engaging with the intervention, such as lack of awareness, logistical issues, or cultural barriers.

Outcome: qualitative
At 0, day 29, 3 months and 6 months
Feasibility: Effectiveness
Time Frame: At 0, day 29, 3 months and 6 months

The trial will be regarded feasible if the following criteria are met:

  • Recruitment rate ≥ 50%
  • ≥ 70% of recruited families complete the trial in one of the intervention groups
  • ≥ 70% of families, researchers and clinical staff agree that the intervention is acceptable (survey)
  • Recruited participants complete ≥ 60% of the supervised sessions
  • ≥ 70% of families agree that the intervention is enjoyable The overall outcome is categorical: Yes, No or yes with conditions/amendments
At 0, day 29, 3 months and 6 months
Feasibility: Adoption
Time Frame: At 0, day 29, 3 months and 6 months
Settings: the proportion of settings that agree to implement the intervention. Outcome measured in percentage.
At 0, day 29, 3 months and 6 months
Feasibility: staff/provider adoption
Time Frame: At 0, day 29, 3 months and 6 months

The proportion and characteristics of researchers and healthcare staff who choose to deliver the intervention.

Outcome in percentages
At 0, day 29, 3 months and 6 months
Feasibility: Barriers and facilitators: Qualitative
Time Frame: At 0, day 29, 3 months and 6 months

Identifies factors that help or hinder the willingness of organisations and individuals to adopt the intervention (e.g., cost, training requirements, organisational culture).

Outcome: quaitative
At 0, day 29, 3 months and 6 months
Feasibility: Fidelity
Time Frame: At 0, day 29, 3 months and 6 months
Fidelity scores ranging from 0 to 100 (e.g., percentage of protocol elements followed) where 0 is nothing was followed and 100 everything was followed as originally planned.
At 0, day 29, 3 months and 6 months
Cost-effectiveness
Time Frame: At 0, 3 months and 6 months

Cost-utility analysis to evaluate the economic value of different interventions (or arms) by comparing their costs to their outcomes. This is based on quality-adjusted life in years. QALY will be generated via measurement of utility values using PedsQL-cancer and Parents PedQL-Cancer instrument mapped to the EQ-5D.

Outcome: scale in pounds and euros. Total cost of control, cost of diet alone and cost of diet and physical activity
At 0, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leptin
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
Candidate secondary outcomes for future RCT: leptin (abcam assay)
Initial assessment, at day 29, at 3 months and at 6 months
Food group indicators and nutrient intake
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
Candidate Secondary Outcome for RCT multiple pass 24-hour recall Food groups (Eatwell Guide and A healthy eating index score (HEI)) Macronutrients and micronutrients (analysed in Nutritics) compared to UK Dietary Recommended Daily Intake (DRVs 1991, SANC 2011) and Spanish Ingestas Nutricionales de Referencia (AESAN 2019)
Initial assessment, at day 29, at 3 months and at 6 months
Physical activity levels min/day
Time Frame: Initial assessment, at 3 months and at 6 months
Candidate secondary outcome for RCT GENEActiv accelerometers (min/day) 5 week days, 2 weekend days (minimum recorded 10 hours)
Initial assessment, at 3 months and at 6 months
Handgrip strength
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
Candidate secondary outcome for RCT hand-held hydraulic dynamometer
Initial assessment, at day 29, at 3 months and at 6 months
Fitness
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
15-foot walk
Initial assessment, at day 29, at 3 months and at 6 months
Side-effects
Time Frame: Throughout the study (0 - 3 months), then again at 6 months
Candidate Secondary Outcome for RCT: treatment side-effects, intervention arms side-effects, hospital admissions (and length), changes in treatment regime (ALLTogether)
Throughout the study (0 - 3 months), then again at 6 months
Gut microbiome composition
Time Frame: Initial assessment and 3 months
Characterisation of gut microbiome composition: α- and β-diversity, relative abundances (comparison between groups) 16sRNA sequencing
Initial assessment and 3 months
Adiponectin
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
Candidate secondary outcome for RCT, Abcam assay
Initial assessment, at day 29, at 3 months and at 6 months
Insulin
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
Candidate secondary outcome for RCT, Oxford Biosyste ELISA
Initial assessment, at day 29, at 3 months and at 6 months
Immunoglobulin A (IgA)
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
IgA (hospital owns assays)
Initial assessment, at day 29, at 3 months and at 6 months
Immunoglobulin G (IgG)
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
IgG - hospital own's laboratory
Initial assessment, at day 29, at 3 months and at 6 months
Immunoglobulin M (IgM)
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
IgM (hospital own's assay)
Initial assessment, at day 29, at 3 months and at 6 months
Total Cholesterol
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
Total Cholesterol (TCh) - hospital owns assay
Initial assessment, at day 29, at 3 months and at 6 months
High Density Lipoprotein (HDL)
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
HDL (hospital own's assay)
Initial assessment, at day 29, at 3 months and at 6 months
Low Density Lipoprotein (LDL)
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
LDL (hospital's own assay)
Initial assessment, at day 29, at 3 months and at 6 months
Triglycerides (TGA)
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
TGA (hospital's own assay)
Initial assessment, at day 29, at 3 months and at 6 months
Glucose
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
Glucose (hospital's own assay)
Initial assessment, at day 29, at 3 months and at 6 months
C-Reactive Protein (CRP)
Time Frame: Initial assessment, at day 29, at 3 months and at 6 months
Standard Sensitivity CRP, hospital's own assay.
Initial assessment, at day 29, at 3 months and at 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterisation of gut microbiome: Diversity
Time Frame: At 0, day 29, 3 months and 6 months
Outcome from 16sRNA sequencing: alpha and beta bacteria.
At 0, day 29, 3 months and 6 months
Gut microbiome: Relative abundance
Time Frame: At 0, day 29, 3 months and 6 months
Relative abundances (comparison between groups: alpha and beta bacteria)
At 0, day 29, 3 months and 6 months

Collaborators and Investigators

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

Sponsor

University of Exeter

Investigators

  • Study Chair: Raquel Revuelta Iniesta, PhD, University of Exeter
  • Study Chair: Carmen Fiuza Luces, PhD, Hospital 12 de Octubre Research Institute
  • Study Director: Raquel Revuelta Iniesta, PhD, University of Exeter

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

February 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 22, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BREVARY_Mad_Exe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Given the sensitive nature of hospital patient data and the feasibility focus of your study, sharing individual participant data does not align with ethical guidelines, data protection regulations, and the consent provided by participants.

Study Data/Documents

  1. Protocol and ethics can be shared on request
    Information comments: Information will be shared following ethical approval on relevant websites

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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