Condition category
Not Applicable
Date applied
11/12/2019
Date assigned
13/12/2019
Last edited
13/12/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 2021

Who is funding the study?
University of Valencia (Spain)

Who is the main contact?
Prof. José V. Sorlí
sorli@uv.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose V Sorlí

ORCID ID

http://orcid.org/0000-0002-0130-2006

Contact details

Avda. Blasco Ibanez 15
Valencia
46010
Spain
+34 (0)963864417
sorli@uv.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PCT2E-19

Study information

Scientific title

Changes in taste perception and smell detection after a healthy lifestyle intervention: a randomized and controlled clinical trial

Acronym

TASMELL

Study hypothesis

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

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

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

22/10/2019

Overall trial end date

18/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Volunteers recruited from the general population
2. Between 30 and 65 years old
3. BMI between 23 and 35 kg/m2

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

60 participants randomised in two groups (30 intervention group and 30 in the control group)

Participant 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

Recruitment start date

20/12/2019

Recruitment end date

04/12/2020

Locations

Countries of recruitment

Spain

Trial participating centre

University of Valencia
School of Medicine Avda. Blasco Ibanez 15
Valencia
46010
Spain

Trial participating centre

CIBER OBN
Instituto de Salud Carlos III. Calle Sinesio Delgado 10
Madrid
28029
Spain

Sponsor information

Organisation

University of Valencia

Sponsor details

Avda. Blasco Ibanez 13
Valencia
46010
Spain
+34 (0)963864417
dolores.corella@uv.es

Sponsor type

University/education

Website

https://www.uv.es

Funders

Funder type

University/education

Funder name

Universitat de València

Alternative name(s)

University of Valencia, 85|86

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Spain

Results and Publications

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 statement
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.

Intention to publish date

27/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/12/2019: Trial's existence confirmed by the Ethics Committee at the University of Valencia.