Personalised nutrition intervention for breast cancer survivors based on individual molecular analyses (nutrigenetics, lipidomics and microbiomics)

ISRCTN ISRCTN13901439
DOI https://doi.org/10.1186/ISRCTN13901439
Secondary identifying numbers TUE-SUR-2018-01
Submission date
05/08/2021
Registration date
19/10/2021
Last edited
02/11/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
It is well known that cancer survivors have an increased risk of suffering from other chronic diseases, such as diabetes and cardiovascular diseases, as well as increased risk of recurrence and second malignancies. In an effort to prevent, or at least reduce, the severity of many of these diseases, a healthy and balanced diet is currently promoted by numerous cancer organizations to ensure optimal health status.
A clinical nutritional trial will be carried out with 50 breast cancer survivors, to evaluate the benefit of personalized nutritional advice on their metabolic and nutritional status. Nutritional advice will be based on individual metabolic and genetic profiles determined at the beginning of the intervention, as well as from food frequency questionnaires to determine habitual dietary intake. Intestinal microbiota will be measured throughout the intervention to assess the impact of the personalized nutritional advice on gut health. Efficacy of the nutritional advice will be determined by whether individual metabolic profiles can reach an optimal metabolic state.

Who can participate?
Breast cancer survivors.

What does the study involve?
The study involves a few hospital visits in 1 year, where blood samples will be taken from participants and they will personally meet the nutritionist.

What are the possible benefits and risks of participating?
The participants will benefit from a personalised diet (intervention group) or healthy general diet (control group). There are no other risks than the ones associated with the blood extraction procedures.

Where is the study run from?
AZTI (Spain)

When is the study starting and how long is it expected to run for?
December 2020 to May 2024

Who is funding the study?
Spanish Association Against Cancer (AECC)

Who is the main contact?
Itziar Tueros PhD, itueros@azti.es

Contact information

Dr Itziar Tueros
Scientific

Parque Tecnológico de Bizkaia
Astondo Bidea 609
Derio
48160
Spain

ORCiD logoORCID ID 0000-0002-7609-5435
Phone +34 667174290
Email itueros@azti.es
Dr Mercedes Caro
Public

Parque Tecnológico de Bizkaia
Astondo Bidea 609
Derio
48160
Spain

ORCiD logoORCID ID 0000-0002-9507-9502
Phone +34 667100352
Email mcaro@azti.es

Study information

Study designProspective interventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please, use contact details to request a participant information sheet (available in spanish only)
Scientific titlePrecision nutrition for breast cancer survivors based on molecular tools: nutrigenetics, lipidomics and microbiomics
Study acronymSUMA
Study objectivesThe understanding of the interactions among diet and metabolism is necessary to formulate the best nutritional recommendations and thus help people achieve their health goals. Consequently, through a methodology that integrates different omic tools, it is feasible to evaluate each patient individually, and based on their molecular characteristics, it is possible to design a personalized nutritional monitoring strategy considering diet and supplementation adapted to their nutritional requirements. This strategy would work as a guide for the control and care of the survivors' health, not only at the time of the check-up but also in the future
Ethics approval(s)Approved 20/07/2021, Research Ethics Committee of the Health Area from Gipuzkoa (PºDoctor Beguiristains/n. 20014 Donostia-San Sebastian, Spain; +34 943007402; mjose.velazquezzubicoa@osakidetza.eus), ref: TUE-SUR-2018-01
Health condition(s) or problem(s) studiedNutritional and metabolic status, and well being of breast cancer survivors
InterventionProspective randomized controlled clinical trial with nutritional intervention for a year with a total of 50 breast cancer survivors. Participants will be randomly divided into two equal size groups: control (C) and personalized diet (D).

At the beginning of the study, blood samples will be obtained for the analysis of membrane lipidomic, nutrigenetic and epigenetic and biochemical parameters. Stool samples will be also collected to analyse gut microbiome. The anthropometric parameters will be also measured, and all patients will complete a validated quality of life (QoL) questionnaire and food frequency questionnaire (FFQ).

The Diet Group (D) participants will be provided with a personalized nutritional strategy (diet + supplementation) based on the erythrocyte membrane lipid profile and genetic profile, that will last 12 months.

The control group (C) will not receive personalized nutritional advice but they will have a general recommendation based on the Mediterranean diet and a placebo supplement. Follow-up questionaries and analyses will be done at 6 and 12 months.

Randomisation:
Oxmar software will be used. Groups will be distributed according to a random assignment sequence. In this way, we increase the probability that the two groups (control and intervention) are comparable with respect to age and pre- and post-menopause. In addition, the OxMaR system allows the concealment of the randomization sequence (OSA), as required by the CONSORT directive, since an SSL security and encryption system will be used, and a password access system to keep the randomization sequence hidden.
Intervention typeBehavioural
Primary outcome measure1. Metabolic status will be measured as the rebalance of the lipidomic analyses and other biochemical parameters (standard biochemistry parameters: blood cholesterol, TG.) together with anthropometric parameters at 6 and 12 months.
2. Well-being will be measured using validated questionaries (EORTC QLQ-30 or similar) at 6 and 12 months.
3. Improvements of dietary habits will be assessed by validated food frequency questionnaire (FFQ from predimed) at 6 and 12 months.
Secondary outcome measuresCancer recurrence: relapses will be measured at 12 months using patient records
Overall study start date01/12/2020
Completion date30/05/2024

Eligibility

Participant type(s)Other
Age groupMixed
SexFemale
Target number of participants50
Total final enrolment50
Key inclusion criteriaBreast cancer survivors (at least 6 months after treatment), with hormonal treatment
Key exclusion criteria1. Metastasis
2. Severe malnutrition
3. Allergy to fish
4. Any difficulty to take supplements
5. Without gallbladder
Date of first enrolment01/09/2021
Date of final enrolment20/09/2022

Locations

Countries of recruitment

  • Spain

Study participating centre

Fundación Onkologikoa Fundazioa. Unidad de Gestión Clínica de Cáncer, Osakidetza
P. Dr Beguiristain 121.
Donostia- San Sebastian
20014
Spain

Sponsor information

AZTI - Member of the Basque Research & Technology Alliance
Research organisation

Parque tecnologico bizkaia
Astondo Bidea Ed 609
Derio
48160
Spain

Phone +34 667100352
Email ays@azti.es
Website http://www.azti.es

Funders

Funder type

Charity

Fundación Científica Asociación Española Contra el Cáncer
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Fundación Científica de la Asociación Española Contra el Cáncer, Fundación Científica AECC, Scientific Foundation, Spanish Association Against Cancer, AECC
Location
Spain

Results and Publications

Intention to publish date30/05/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planResults will be disseminated in conferences and specialized scientific journals on nutrition and oncology. Also at university level, as participant researchers are lecturers in nutrition and health topic. Moreover, dissemination of results will be done for general public, in conferences in informative format, but also by publications in digital media.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available

Editorial Notes

02/11/2023: The following changes were made to the trial record:
1. The overall end date was changed from 30/12/2023 to 30/05/2024.
2. The intention to publish date was changed from 30/04/2024 to 30/05/2024.
3. The plain English summary was updated to reflect these changes.
27/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2022 to 20/09/2022.
2. The overall end date was changed from 30/12/2023 to 30/12/2023.
3. The intention to publish date was changed from 30/11/2023 to 30/04/2024.
4. The total final enrolment was added.
5. The plain English summary was updated to reflect these changes.
21/09/2022:The overall trial end date was changed from 30/09/2023 to 30/12/2023.
15/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2022 to 30/09/2022.
2. The overall end date was changed from 31/03/2023 to 30/09/2023.
3. The intention to publish date was changed from 31/03/2023 to 30/11/2023.
4. The plain English summary was updated to reflect these changes.
06/08/2021: Trial's existence confirmed by Osakidetza Ethics Committee.