Nutritional study to determine the efficacy of dry blood spots, urine and faeces metabolite profiles for dietary assessment
| ISRCTN | ISRCTN47135203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47135203 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | M10_2022_435MR1 |
| Sponsor | Fundación AZTI |
| Funders | European Union Horizon Programme, Basque Government (IKERTALENT Scholarship Program 2021) |
- Submission date
- 16/10/2024
- Registration date
- 22/10/2024
- Last edited
- 05/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Nutritional research is trying to find better ways to understand what people eat. Current methods, like food frequency questionnaires, aren’t very accurate. Researchers need new, easy, and affordable tools to get reliable results. Validating the use of dried blood spots (DBS) as a minimally invasive tool to monitor dietary fat intake, and analyzing metabolites in urine and faeces, we can better understand the relationship between diet and metabolism. This approach, combined with simple dietary questionnaires, will help improve our understanding of how diet influences health.
Who can participate?
Healthy volunteers (male and female), aged 18-65 years old.
What does the study involve?
Participants will provide general information such as age, sex, date of birth, weight, height, disease parameters, lifestyle, physical activity, and dietary habits through a brief online questionnaire, which takes 5-10 minutes to complete. Before collecting biological samples, participants will provide detailed food intake information and complete a short online digestive health questionnaire, which takes about 3 minutes.
Biological samples (capillary blood and urine) will be collected on 6 different days over 3 weeks. Faecal samples will be collected at home on days 1, 7, and 21.
The nutritional intervention involves no fish intake in the first week, followed by 2 weeks consuming 2 servings of canned mackerel and 1 serving of any other lean fish per week, while maintaining their usual diet. Daily food intake will be registered.
What are the possible benefits and risks of participating?
There are no risks of participating. The possible benefits are to enhance more accurate knowledge about dietary intake.
Where is the study run from?
AZTI (Spain)
When is the study starting and how long is it expected to run for?
April 2023 to December 2026
Who is funding the study?
European Union under Horizon Europe project
Basque Government (IKERTALENT Scholarship Program 2021) (Spain)
Who is the main contact?
1. Dr. Sara Arranz, sarranz@azti.es
2. Laura García Urtiaga, lgarcia@azti.es
Contact information
Public, Principal investigator
Fundación AZTI
Parque Tecnológico de Bizkaia
Astondo Bidea, edificio 609
Derio
48160
Spain
 ORCID ID |
0000-0003-2397-5145 |
|---|---|
| Phone | +34 671750399 |
| sarranz@azti.es |
Scientific
Fundación AZTI
Parque Tecnológico de Bizkaia
Astondo Bidea, edificio 609
Derio
48160
Spain
| ORCID ID |
0009-0009-5110-6538 |
|---|---|
| Phone | +34 667141250 |
| lgarcia@azti.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center nutritional intervention study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Pilot study on the impact of nutritional and lifestyle habits on the profile of fatty acids in dried blood Spots (DBS) and metabolites in urine and faeces |
| Study objectives | Incorporating the measurement of fatty acids in dried blood spots (DBS) and analyzing metabolites in urine and feces as minimally invasive tools will yield more precise information on an individual’s nutritional status |
| Ethics approval(s) |
Approved 23/10/2023, CEISH-UPV/EHU (Bizkaia Campus, Sarriera Auzoa, Leioa, 48940, Spain; +34 946012430; astrid.beascoa@ahu.eus), ref: M10_2022_435MR2_GARCÍA URTIAGA |
| Health condition(s) or problem(s) studied | Efficacy of dry blood spots, urine and faeces metabolite profiles for dietary assessment |
| Intervention | The participants of this study were recruited from AZTI staff in Derio (Bizkaia) from October to November 2023. In total, 24 healthy volunteers aged 18-65 years were involved in the study, with 18 completing the nutritional intervention study. Participants will provide general information about lifestyle, physical activity, dietary habits and digestive health through a brief online questionnaire, which takes 5-10 minutes to complete. Participants are required to maintain their usual diet for two weeks, recording daily food intakes. This was followed by a 3 weeks nutritional intervention period: one-week washout period restricting fish and shellfish. For the next two weeks, participants consumed two portions of canned mackerel and one portion of lean fish weekly, with no other dietary restrictions. Daily dietary habits were recorded during 3 weeks. Capillary Blood and urine samples were collected at six time points in night fasting condition: baseline (T0), after one week of fish restriction (T1), one day after T1 (having consumed a portion of mackerel the night before of the sample collection time) (T2), after the first week of intervention (T3), one day after T3 T1 (as for T2, having consumed a portion of mackerel the night before of the sample collection time) (T4), and after the second week of intervention (T5). Fish and shellfish intake was restricted 24 hours before all collection points except T2 and T4. Faeces samples were collected only at three time points (T0, T1 and T5). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. General information about lifestyle, physical activity, dietary habits, and digestive health is measured using a brief online questionnaire at baseline |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Total final enrolment | 24 |
| Key inclusion criteria | Healthy male and female aged 18-65 years old. |
| Key exclusion criteria | 1. Diagnosed disease. 2. Taking medication. 3. Consuming or having consumed omega-3 supplements in the last 6 months. 4. Cancer in the last 6 months. 5. Pregnant or breastfeeding women. 6. Have undergone a nutritional intervention diet in the last 6 months. |
| Date of first enrolment | 30/10/2023 |
| Date of final enrolment | 30/11/2023 |
Locations
Countries of recruitment
- Spain
Study participating centre
Parque Tecnológico de Bizkaia
Astondo Bidea E609
Derio
48160
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made publicly available. All data will be published as group summaries and anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/08/2025 | 05/08/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/08/2025: Publication reference added.
18/12/2024: The intention to publish date was changed from 31/12/2024 to 31/12/2027.
16/10/2024: Trial's existence confirmed by CEISH-UPV/EHU.
