A study analyzing if a healthy diet improves the taste preference profile and flavor perception
| ISRCTN | ISRCTN14827027 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14827027 |
| Secondary identifying numbers | PTN_1896892 |
- Submission date
- 10/12/2021
- Registration date
- 13/12/2021
- Last edited
- 10/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Taste and smell alterations represent an increasingly important problem in nutrition, and in public health. Currently, it is of enormous interest, not only to know the relationship between perception and preferences taste, smells and eating patterns and cardiometabolic and cognitive variables at a specific moment, but also to know their dynamic evolution, and what is more important, to know the factors that can improve taste and smell perception and preference patterns. Following the COVID-19 epidemic, some pharmacological interventions have been proposed to regain taste and olfactory ability in people who had lost it. However, our aim is to study if an intervention with a healthy diet can improve the perception of flavors (taste and smell), as well as change the preference for certain flavors (tastes and smell) in a general Mediterranean population after 6 months of intervention, compared to a control group.
Who can participate?
Men and women from the general population (aged 25-75 years)
What does the study involve?
Participants will be randomly allocated 1:1 to two groups (intervention and control group) using a computer algorithm: The intervention group consisting of 100 individuals will receive nutritional advice to follow a healthy diet (Mediterranean-based diet low in ultra-processed foods) for 6 months (with an individual session every month). No intervention will be carried out in the control group. The primary outcomes will be changes in flavor (taste and smell) preferences, taste perception, and odor perception from baseline to 6 months using standard tests. In addition, anthropometric, blood pressure, food intake, physical activity, sleep, chronotype, and some cognitive variables will be measured.
What are the possible benefits and risks of participating?
Participants will be informed that there are no benefits and risks expected.
Where is the study run from?
University of Valencia (Spain)
When is the study starting and how long is it expected to run for?
October 2021 to January 2025
Who is funding the study?
University of Valencia (Spain)
Who is the main contact?
Carolina Ortega-Azorín
Carolina.Ortega@uv.es
Contact information
Scientific
School of Medicine
Avda Blasco Ibanez, 15
Valencia
46010
Spain
 ORCID ID |
0000-0001-6719-9358 |
|---|---|
| Phone | +34 963864800 |
| carolina.ortega@uv.es |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of the intervention with a healthy diet on the flavor preference profile and improvement of taste and odor perception in a Mediterranean population: A randomized and controlled clinical trial |
| Study acronym | TASTOR |
| Study objectives | The intervention with a healthy diet can improve the perception of flavors (taste and smell), as well as change the preference for certain flavors (tastes and smell) in a general Mediterranean population after 6 months of intervention, compared to a control group. |
| Ethics approval(s) | Approved 09/11/2021, Institutional review board of Valencia University (human subjects) (Avda. Blasco Ibanez 13, Valencia, ZIP 46010, Spain; +34 963864109; vicerec.investigacio@uv.es), ref: PTN_1896892 |
| Health condition(s) or problem(s) studied | Improving flavor perception and preferences in the general population |
| Intervention | Participants (n=200) will be randomized 1:1 to 2 arms (intervention and control groups) using an online tool (compute program). One study arm (n=100 participants) will receive the intervention consisting of a healthy diet for 6 months. The other study arm, the control group (n=100 participants) will receive no intervention for 6 months, only the baseline visit and the final visit after 6 months. The intervention group will receive nutritional advice to follow a healthy diet (consisting of a Mediterranean-based dietary pattern low in ultra-processed foods) for 6 months by a registered dietitian. In addition, every months a face-to-face individual session for reinforcing the nutritional advice and increasing compliance with the healthy diet will be carried out |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline and 6 months: 1. Flavor preferences (all the tastes and selected odors will be measured using the 9-item hedonic scales) 2. Taste perception: intensity rating test with prototypic tastants for (bitter, sweet, sour, umami, and salty) at different concentrations will be carried out in the laboratory 3. Odor perception tests using the "NHANES Odor Test" (US National Health and Nutrition Examination Survey) protocol |
| Secondary outcome measures | 1. Anthropometric measures (by bioimpedance) at baseline and 6 months in both groups. 2. Blood pressure and heart rate parameters, at baseline and after 6 months in both groups by standard procedures 3. The level of adherence to the Mediterranean Diet through the 17-ite questionnaire at baseline and at 6 months. 4. Food intake (by a FFC) at baseline and 6 months. 5. Physical activity measured using the short form of the Minnesota physical activity questionnaire at baseline. 6. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire at baseline and at 6 months. 7. Chronotype at baseline, measured using the Horne and Östberg questionnaire. 8. Cognitive tests, measuring semantic and phonemic verbal capacity and average executive control, the Controlled Oral Word Association Test (COWAT), and the memory alteration test (T @ M) at baseline and after 6 months. 9. Quality of life (SF-36 or SF-12) at baseline and after 6 months. |
| Overall study start date | 09/10/2021 |
| Completion date | 01/01/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Adults from the general population (50% women) 2. Age range of 25 to 75 years 3. Body mass index (BMI) of 25 to 35 kg/m² |
| Key exclusion criteria | Those individuals who do not meet the inclusion criteria or who present the following conditions: 1. Allergy to the tastants or to any food recommended in the healthy dietary pattern 2. Pregnant or lactating women 3. Infectious diseases 4. Kidney or liver diseases 5. Cancer 6. Other relevant pathologies that could bias the study |
| Date of first enrolment | 21/12/2021 |
| Date of final enrolment | 31/03/2024 |
Locations
Countries of recruitment
- Spain
Study participating centres
Avda. Blasco Ibanez 15
Valencia
46010
Spain
Pabellon 11
Madrid
28029
Spain
Sponsor information
University/education
Avda. Blasco Ibanez, 13
Valencia
46010
Spain
| Phone | +34 963864100 |
|---|---|
| olga.portoles@uv.es | |
| Website | http://www.uv.es/ |
"ROR" |
https://ror.org/043nxc105 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Valencia, 85|86
- Location
- Spain
No information available
Results and Publications
| Intention to publish date | 30/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Findings regarding the main hypothesis will be published in international journals related to the field. Communications in related scientific meetings are planned. |
| IPD sharing plan | Data will not be available outside the core research group. Researchers who are interested in this study can contact the main investigator (Carolina.ortega@uv.es) if they have any questions regarding the data or are interested in further collaborations. The participants will receive written information about what the study involves and sign a consent form before entering the study. In the informed consent form, the participant is informed that the individual-level data will not be publicly available. |
Editorial Notes
10/07/2024: The following changes were made:
1. The recruitment end date was changed from 30/09/2023 to 31/03/2024.
2. The overall end date was changed from 01/07/2024 to 01/01/2025.
3. The intention to publish date was changed from 31/01/2025 to 30/07/2025.
29/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2022 to 30/09/2023.
2. The overall end date was changed from 01/07/2023 to 01/07/2024.
3. The intention to publish date was changed from 31/01/2024 to 31/01/2025.
4. The plain English summary was updated to reflect these changes.
13/12/2021: Trial's existence confirmed by Institutional review board of Valencia University.
