Does an intervention with a healthy lifestyle change taste perception and smell detection?
| ISRCTN | ISRCTN34388605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34388605 |
| Secondary identifying numbers | PCT2E-19 |
- Submission date
- 11/12/2019
- Registration date
- 13/12/2019
- Last edited
- 14/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Taste and smell perception decreases with age and both are characteristic of ageing. An impaired olfactory capacity has been significantly associated with all-cause mortality, mainly due to neurodegenerative and cardiovascular diseases. Likewise, a decreased taste perception has been associated with greater adiposity, including weight, waist circumference and body mass index. Therefore, the aim of this study is to analyze if an intervention with a healthy lifestyle including a healthy diet, increased physical activity and a healthy sleep pattern (for 1 year) is able to improve taste and smell perception in the general population, compared to a control group.
Who can participate?
Healthy men and women from the general population (aged 30-65)
What does the study involve?
Participants are randomly allocated to two groups (intervention and control group). The intervention (healthy lifestyle) includes nutritional education to increase adherence to a healthy diet, the Mediterranean diet. The intervention also includes increasing physical activity, personalized to the characteristics of the participants. In addition, interventions promoting healthy sleep habits according to age are carried out according to the recommendations of the Spanish Sleep Society. Every three months intervention group participants are requested for individual sessions and visits to reinforce the intervention. The control group do not have any type of intervention, only first and final visits. In addition, anthropometric, blood pressure and other lifestyle variables are assessed and compared. The duration of follow-up is 1 year.
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 2019 to December 2023
Who is funding the study?
University of Valencia (Spain)
Who is the main contact?
Prof. José V. Sorlí
sorli@uv.es
Contact information
Scientific
Avda. Blasco Ibanez 15
Valencia
46010
Spain
 ORCID ID |
0000-0002-0130-2006 |
|---|---|
| Phone | +34 (0)963864417 |
| sorli@uv.es |
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Changes in taste perception and smell detection after a healthy lifestyle intervention: a randomized and controlled clinical trial |
| Study acronym | TASMELL |
| Study objectives | The hypothesis is that a healthy lifestyle intervention consisting of nutritional education for a healthy diet, increased physical activity and healthy sleep habits, improves taste and smell perception, when compared to a control group. |
| Ethics approval(s) | Approved 05/12/2019, Institutional review board of Valencia University (human subjects) (Avda. Blasco Ibanez 13, Valencia, ZIP 46010, Spain; Tel: +34 (0)963864109; Email: vicerec.investigacio@uv.es), ref: UV-INV_ETICA-1205661 |
| Health condition(s) or problem(s) studied | Taste-smell |
| Intervention | This is a parallel randomized controlled trial including 60 participants (30 people in the intervention group and 30 people in the control group). Participants will be randomly assigned to the control or intervention group 1:1 by simple random assignment through a computer program. The intervention (healthy lifestyle) will be carried out with nutritional education to increase adherence to a healthy diet, the Mediterranean diet. The intervention also will consist of increasing physical activity, in which physical activity will be personalized to the characteristics of the participants. In addition, the intervention promoting healthy sleep habits according to age will be carried out according to the recommendations of the Spanish Sleep Society. The intervention will be carried out for one year. Every three months intervention group participants will be requested for individual sessions and visits to reinforce the intervention. The control group will not have any type of intervention, only baseline and final visits. The duration of follow-up will be 1 year. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Taste perception measured by a validated test (for sweet, salty, bitter, acid and umami flavors) at baseline and after intervention 2. Smell detection measured by a validated test called “Sniffin´Sticks” at baseline and after intervention |
| Secondary outcome measures | 1. Blood pressure measured at baseline and after intervention 2. Weight, height, waist circumference and body composition by bioimpedance measured at baseline and after intervention 3. Food intake and adherence to the Mediterranean diet measured using the 14-item Mediterranean diet adherence PREDIMED scale at baseline and after intervention 4. Physical activity measured using the short form of the Minnesota physical activity questionnaire at baseline and after intervention 5. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire at baseline and after intervention 6. Chronotype measured using the Horne and Östberg questionnaire at baseline and after intervention 7. Cognitive function measured using some tests (TMT-A, TMT-B, COWAT, Wechsler Adult Intelligence Scale-III) at baseline and after intervention |
| Overall study start date | 22/10/2019 |
| Completion date | 18/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 participants randomised in two groups (30 intervention group and 30 in the control group) |
| Key inclusion criteria | 1. Volunteers recruited from the general population 2. Between 30 and 65 years old 3. BMI between 23 and 35 kg/m2 |
| Key exclusion criteria | 1. Diseased 2. Diabetics 3. Immunodeficiency or HIV-positive status 4. Liver cirrhosis or chronic renal failure 5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc 6. Any severe co-morbid condition 7. Alcohol abuse or addition 8. History of major organ transplantation 9. Concurrent therapy with immunosuppressive drugs or cytotoxic agents 10. Current treatment with systemic corticosteroids 11. Current use of weight loss medication 12. Patients with an acute infection or inflammation 13. Pregnant or breastfeeding women 14. Any other condition that may interfere with the completion of the study protocol |
| Date of first enrolment | 20/12/2019 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- Spain
Study participating centres
Avda. Blasco Ibanez 15
Valencia
46010
Spain
Madrid
28029
Spain
Sponsor information
University/education
Avda. Blasco Ibanez 13
Valencia
46010
Spain
| Phone | +34 (0)963864417 |
|---|---|
| dolores.corella@uv.es | |
| Website | https://www.uv.es |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Valencia, 85|86
- Location
- Spain
Results and Publications
| Intention to publish date | 27/12/2023 |
|---|---|
| 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 first in international journals related to nutrition, obesity and taste. Later publications will include further secondary analyses. Posters and oral 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 (Dr JV Sorlí, sorli@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
14/07/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 04/12/2020 to 01/06/2023.
2. The overall trial end date was changed from 18/12/2021 to 18/12/2023.
3. The intention to publish date was changed from 27/12/2021 to 27/12/2023.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
13/12/2019: Trial's existence confirmed by the Ethics Committee at the University of Valencia.
