ObesitySukalmenaNCT04908163
Sukalmena InAge: Nutritional-culinary Programme to Promote Adherence to a Healthy Dietary Pattern.
A study testing Mediterranean diet-based nutritional education intervention and Mediterranean diet-based culinary intervention in people with Obesity and Healthy Aging, run by Basque Culinary Center Fundazioa at 1 site in Spain.
Trial summary
Currently, one of the main health challenges of public health is to improve the quality of life of people with chronic non-communicable diseases, through new strategies that promote healthy eating habits and lifestyles. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Obesity, Healthy Aging, Cognitive Impairment
- What is being tested?
- Mediterranean diet-based nutritional education intervention and Mediterranean diet-based culinary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 26 May 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obesity (BMI between 25 and 35 kg/m2)
- Low score in the screening questionaire "Homecooking Quality Index" (HQI)
Who cannot join
- Pregnant or lactating women.
- Serious medical condition precluding dietary intervention or limiting survival to less than one year.
- Illicit drug use, chronic alcoholism.
- Participation in any clinical trial with drugs or dietary intervention during the year prior to inclusion.
- Weight loss intervention (surgical treatment, dietary or pharmacological treatment) during the last year
- Difficulty or major drawbacks to change dietary habits and follow Mediterranean diet (allergies, intolerances).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Basque Culinary Center Fundazioa
Donostia / San Sebastian, Gipuzkoa, 20009
About this study
Official title: Feasibility Study for the Development of a Nutritional-culinary Programme to Tackle Overweight or Obesity as a Strategy to Promote Adherence to a Healthy Dietary Pattern.
Currently, one of the main health challenges of public health is to improve the quality of life of people with chronic non-communicable diseases, through new strategies that promote healthy eating habits and lifestyles.
Within the new strategies that aim to promote and improve the eating habits of the population, "Sukalmena-InAge" is proposed as a tool for transforming health, where culinary skills and nutritional knowledge converge as a new paradigm to promote health. The merging of culinary knowledge and nutritional education has been coined under the term Culinary Medicine.
Read more
The present project is presented as an innovative strategy to improve dietary habits of overweight/obese people. To this end, volunteers will participate in an intervention that will be based on cooking workshops and nutritional education. In this sense, participants will receive different cooking and nutritional education sessions in order to be able to give them resources to cook in an easy, enjoyable and healthy way.
The study will evaluate the effect that this nutritional-culinary intervention programme might exert on health and will compare these results with the effects obtained providing a more traditional nutritional education.
The potential effects will be evaluated through the measurement of specific biochemical parameters related to the most prevalent chronic diseases ( insulin, glucose, total cholesterol, triglycerides, among others). In addition, the measurement of advanced glycation end products (AGEs) in tissue will be carried out. High consumption of AGEs, could induce negative effects on health and has been correlated with the type of food consumed, but also with the culinary techniques used for their preparation.
Read the detailed description
Lifestyle interventions are nowadays focused on promoting health and preventing chronic diseases. However, when it comes to changing lifestyle habits, and more specifically, dietary habits, the acquisition and maintenance of these modifications over time is often complex due to many factors that may affect.
There is a consensus among health professionals that, based on the available scientific evidence, a diet based on a high consumption of fruit and vegetables is inversely associated with the risk of developing chronic non-communicable diseases and, overall, with lower mortality rates. These protective effects might be in part due to certain nutrients present in the mentioned foods, namely biologically active compounds or bioactive compounds, such as mono- and polyunsaturated fatty acids, fibre, phytochemicals, antioxidant vitamins, minerals, ω-3 fatty acids and plant proteins. These compounds exert antiinflammatory and antioxidant effects, thus, as part of a healthy dietary pattern, they may have the capacity to preserve healthy ageing, for instance, in relation to cognitive status.
Nevertheless, the role of culinary methods from a healthy dietary perspective should not be forgotten. During culinary processes the nutrient content can be modified, contributing not only to the loss or enhancement of beneficial nutrients such as biologically active components (CBAs), but also to the formation of compounds that might be harmful or toxic for the human organism, for example, Advanced Glycation End Products (AGEs).
Taking this into consideration, this study seeks to develop a pilot study to analyse the feasibility and preliminary efficacy of a nutritional-culinary programme aiming to promote long-term healthy ageing in overweight or obese adults. Volunteers participating in the intervention will receive nutritional recommendations based on a healthy dietary pattern such as Mediterranean Diet, together with a culinary training, seeking to empower them in cooking techniques and culinary capacities.
In conclusion, this study aims to evaluate the effectiveness of a nutritional-culinary intervention to produce beneficial effects on health parameters of overweight/obese patients and to compare the results obtained with the health effects obtained through a nutritional intervention without a culinary training.
- Conditions
- Obesity, Healthy Aging, Cognitive Impairment
- Being tested
- Mediterranean diet-based nutritional education intervention, Mediterranean diet-based culinary intervention
- Keywords
- Mediterranean diet, Culinary intervention, Cooking classes, Nutritional education, Confidence
- Medical subject headings
- Obesity, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet-based nutritional education interventionBehavioural
The patients in the nutritional intervention group will receive dietary advice on how to follow a Mediterranean diet. The dietary recommendations will be given at the beginning of the study by nutritionists using comprehensive written material.
Mediterranean diet-based culinary interventionBehavioural
The culinary intervention will be developed integrating eight culinary and nutritional workshops that will be given every week, twice per week, during one-month intervention. The duration of each culinary and nutritional workshop will be 1 hour, thus, the program will provide a total of hours of nutritional education and a total of 8 hours of nutritional and cooking training. The courses will take place in a well-equipped kitchen from the Basque Culinary Center and participants will be connected online in order to be able to cook and practice at the same time. All cooking classes will begin with a theoretical introductory part that aim to explain the main take-home messages from the workshop. Subsequently, every class will be characterized by a hands-on part that will include the demonstration and practical preparation of different elaborations based on the use specific cooking techniques and healthy ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional education group (NEG) | Active comparator | Participants in the nutritional education group will be given a leaflet with written nutrition educational information to follow a Mediterranean diet. Participants will be encouraged to adhere to this diet for one month. Four visits will be scheduled for participants assigned to this group:
(1) before randomization (T1); (2) after randomization and before the the beginning of the intervention (T2); and (3) (4) after the intervention (T3)(T4). In all time-points, questionnaires will be registered and at T2 and T4 blood samples will be collected and advanced glycation end-products will be measured. Receives: Behavioral: Mediterranean diet-based nutritional education intervention |
| Culinary intervention group (CIG) | Experimental | Participants assigned to the culinary intervention group will receive a written nutrition educational information as well as eight online nutritional and cooking classes during the one-month intervention period. Four visits will be scheduled for participants assigned to this group:
(1) before randomization (T1); (2) after randomization and before the the beginning of the intervention (T2); and (3) (4) after the intervention (T3)(T4). In all time-points, questionnaires will be registered and at T2 and T4 blood samples will be collected and advanced glycation end-products will be measured.
Participants will receive 8 culinary workshops between visit 2 and visit 3. In all time-points, questionnaires will be registered and at T2 and T4 blood samples will be collected and advanced glycation end-products will be measured.
Volunteers will be also contacted by phone after 6 months of the end of the intervention to collect information about food and culinary habits. Receives: Behavioral: Mediterranean diet-based culinary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to the Mediterranean Diet measured by Mediterranean Diet Adherence Screener (MEDAS)
At baseline, data about adherence to the Mediterranean Diet will be collected by a 14-point Mediterranean Diet Adherence Screener (MEDAS). 4 weeks post-baseline and 6 months post-baseline data from this questionnaire will be also collected. The MEDAS score can range from 0 to 14 and higher scores mean better outcome.
- Unabbreviated scale title: Mediterranean Diet Adherence Screener
Measured: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
Change in the Frequency of Cooking Habits Questionnaire
At baseline, data about the Frequency of Cooking Habits will be collected by a 24-point questionnaire. 4 weeks post-baseline and 6 months post-baseline, data from this questionnaire will be also collected.
Measured: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
Change in the Confidence towards cooking Questionnaire
At baseline, data about the Confidence towards cooking will be collected by a 18-point questionnaire. 4 weeks post-baseline and 6 months post-baseline data from this questionnaire will be also collected. The Confidence towards cooking questionnaire can range from 18 to 90 and higher scores mean better confidence.
Measured: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
Change in the Attitude towards cooking Questionnaire
At baseline, data about the attitute towards cooking will be collected by a 18-point questionnaire. 4 weeks post-baseline and 6 months post-baseline data from this questionnaire will be also collected. The Attitude towards cooking questionnaire can range from 18 to 90 and higher scores mean better confidence
Measured: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
Secondary outcomes (16)
Change in biochemical parameters (Fasting glucose)
At baseline blood samples will be collected to measure fasting glucose levels. The second measurement of this parameter will be conducted 4 weeks post-baseline.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (Fasting insulin)
At baseline blood samples will be collected to measure fasting insulin level. The second measurement of this parameter will be conducted 4 weeks post-baseline.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (Fasting total cholesterol)
At baseline blood samples will be collected to measure fasting total cholesterol levels. The second measurement of this parameter will be conducted 4 weeks post-baseline.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (Fasting HDL cholesterol)
At baseline blood samples will be collected to measure fasting HDL cholesterol levels. The second measurement of this parameter will be conducted 4 weeks post-baseline.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (Fasting LDL cholesterol)
At baseline blood samples will be collected to measure fasting LDL cholesterol levels. The second measurement of this parameter will be conducted 4 weeks post-baseline.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (C reactive protein levels)
At baseline blood samples will be collected to measure fasting C reactive protein levels. The second measurement of this parameter will be conducted 4 weeks post-baseline.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (TNFalpha)
At baseline blood samples will be collected to measure TNFalpha levels. The second measurement of this parameter will be conducted 4 weeks post-baseline.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in advanced glycation end products (AGEs) level
At baseline blood samples will be collected for determination of advanced glycation end products levels. 4 weeks post-baseline this determination will be repeated.
Measured: At baseline and after 4 weeks the beginning of intervention
Changes in body mass index (BMI)
BMI will be calculated as body weight (kg) divided by height (m) squared at baseline and 4 weeks post-baseline
Measured: At baseline and after 4 weeks the beginning of intervention
Change in fat mass
At baseline and 4 weeks post-baseline, fat mass will be analyzed by bioimpedance.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in fat free mass
At baseline and 4 weeks post-baseline, fat free mass will be analyzed by bioimpedance.
Measured: At baseline and after 4 weeks the beginning of intervention
Changes in hip circumference
At baseline, hip circumference will be measured with a measuring. 4 weeks post-baseline, the determination of this measurement will be repeated
Measured: At baseline and after 4 weeks the beginning of intervention
Changes in waist circumference
At baseline, waist circumference will be measured with a measuring. 4 weeks post-baseline, the determination of this measurement will be repeated
Measured: At baseline and after 4 weeks the beginning of intervention
Change in blood pressure
At baseline, blood pressure will be measured with a measuring. 4 weeks post-baseline, the determination of this measurement will be repeated
Measured: At baseline and after 4 weeks the beginning of intervention
Change in advanced glycation end products (AGEs) in tissue
At baseline, blood pressure will be measured with a measuring. 4 weeks post-baseline, the determination of this measurement will be repeated.
Measured: At baseline and after 4 weeks the beginning of intervention
Change in dietary intake measured by validated Food Frequency Questionnaire (FFQ)
At baseline data about dietary intake will be collected by using a Food Frequency Questionnaire (FFQ) and 4 weeks post-baseline, these data will be collected again. 6 months post-baseline, these data will be also collected. The FFQ is a 136-item questionnaire
Measured: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start26 May 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized controlled trial design with one-month intervention program and six months of follow-up in order to test the effects of a culinary intervention program to improve cooking and healthy eating behaviour in overweight and obese patients. The culinary intervention program will be given over a one-month period, two days a week for four weeks. Participants in the control group (CG) will receive dietary training based on Mediterranean diet at the baseline visit and a leaflet explaining this dietary pattern. The participants assigned to the culinary intervention program will receive the same nutritional recommendations and eight online nutritional and cooking classes.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Culinary Center Fundazioa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra
- Responsible party
- Sponsor
- Investigators
- Usune Etxeberria, PhD, Principal investigator, BCC Innovation (Basque Culinary Center Fundazioa)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908163
- Sponsor's protocol ID
- PI2021067
- Acronym
- Sukalmena
- Status last verified
- Oct 2023
- First submitted
- 26 May 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zaharia OP, Kupriyanova Y, Karusheva Y, Markgraf DF, Kantartzis K, Birkenfeld AL, Trenell M, Sahasranaman A, Cheyette C, Kossler T, Bodis K, Burkart V, Hwang JH, Roden M, Szendroedi J, Pesta DH. Improving insulin sensitivity, liver steatosis and fibrosis in type 2 diabetes by a food-based digital education-assisted lifestyle intervention program: a feasibility study. Eur J Nutr. 2021 Oct;60(7):3811-3818. doi: 10.1007/s00394-021-02521-3. Epub 2021 Apr 11.
PubMed 33839905Irl B H, Evert A, Fleming A, Gaudiani LM, Guggenmos KJ, Kaufer DI, McGill JB, Verderese CA, Martinez J. Culinary Medicine: Advancing a Framework for Healthier Eating to Improve Chronic Disease Management and Prevention. Clin Ther. 2019 Oct;41(10):2184-2198. doi: 10.1016/j.clinthera.2019.08.009. Epub 2019 Sep 20.
PubMed 31543284Mills S, White M, Brown H, Wrieden W, Kwasnicka D, Halligan J, Robalino S, Adams J. Health and social determinants and outcomes of home cooking: A systematic review of observational studies. Appetite. 2017 Apr 1;111:116-134. doi: 10.1016/j.appet.2016.12.022. Epub 2016 Dec 23.
PubMed 28024883Abate G, Marziano M, Rungratanawanich W, Memo M, Uberti D. Nutrition and AGE-ing: Focusing on Alzheimer's Disease. Oxid Med Cell Longev. 2017;2017:7039816. doi: 10.1155/2017/7039816. Epub 2017 Jan 12.
PubMed 28168012Chou PS, Wu MN, Yang CC, Shen CT, Yang YH. Effect of Advanced Glycation End Products on the Progression of Alzheimer's Disease. J Alzheimers Dis. 2019;72(1):191-197. doi: 10.3233/JAD-190639.
PubMed 31561370
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for the Development of a Nutritional-culinary Programme to Tackle Overweight or Obesity as a Strategy to Promote Adherence to a Healthy Dietary Pattern.
- ClinicalTrials.gov ID
- NCT04908163
- Acronym / sponsor ID
- Sukalmena / PI2021067
- Conditions
- Obesity, Healthy Aging, Cognitive Impairment
- Keywords
- Mediterranean diet, Culinary intervention, Cooking classes, Nutritional education, Confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Basque Culinary Center FundazioaUniversity, hospital or other
- Collaborators
- University of Navarra
- Study start
- 26 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, one of the main health challenges of public health is to improve the quality of life of people with chronic non-communicable diseases, through new strategies that promote healthy eating habits and lifestyles.
Within the new strategies that aim to promote and improve the eating habits of the population, "Sukalmena-InAge" is proposed as a tool for transforming health, where culinary skills and nutritional knowledge converge as a new paradigm to promote health. The merging of culinary knowledge and nutritional education has been coined under the term Culinary Medicine.
The present project is presented as an innovative strategy to improve dietary habits of overweight/obese people. To this end, volunteers will participate in an intervention that will be based on cooking workshops and nutritional education. In this sense, participants will receive different cooking and nutritional education sessions in order to be able to give them resources to cook in an easy, enjoyable and healthy way.
The study will evaluate the effect that this nutritional-culinary intervention programme might exert on health and will compare these results with the effects obtained providing a more traditional nutritional education.
The potential effects will be evaluated through the measurement of specific biochemical parameters related to the most prevalent chronic diseases ( insulin, glucose, total cholesterol, triglycerides, among others). In addition, the measurement of advanced glycation end products (AGEs) in tissue will be carried out. High consumption of AGEs, could induce negative effects on health and has been correlated with the type of food consumed, but also with the culinary techniques used for their preparation.
Detailed description
Lifestyle interventions are nowadays focused on promoting health and preventing chronic diseases. However, when it comes to changing lifestyle habits, and more specifically, dietary habits, the acquisition and maintenance of these modifications over time is often complex due to many factors that may affect.
There is a consensus among health professionals that, based on the available scientific evidence, a diet based on a high consumption of fruit and vegetables is inversely associated with the risk of developing chronic non-communicable diseases and, overall, with lower mortality rates. These protective effects might be in part due to certain nutrients present in the mentioned foods, namely biologically active compounds or bioactive compounds, such as mono- and polyunsaturated fatty acids, fibre, phytochemicals, antioxidant vitamins, minerals, ω-3 fatty acids and plant proteins. These compounds exert antiinflammatory and antioxidant effects, thus, as part of a healthy dietary pattern, they may have the capacity to preserve healthy ageing, for instance, in relation to cognitive status.
Nevertheless, the role of culinary methods from a healthy dietary perspective should not be forgotten. During culinary processes the nutrient content can be modified, contributing not only to the loss or enhancement of beneficial nutrients such as biologically active components (CBAs), but also to the formation of compounds that might be harmful or toxic for the human organism, for example, Advanced Glycation End Products (AGEs).
Taking this into consideration, this study seeks to develop a pilot study to analyse the feasibility and preliminary efficacy of a nutritional-culinary programme aiming to promote long-term healthy ageing in overweight or obese adults. Volunteers participating in the intervention will receive nutritional recommendations based on a healthy dietary pattern such as Mediterranean Diet, together with a culinary training, seeking to empower them in cooking techniques and culinary capacities.
In conclusion, this study aims to evaluate the effectiveness of a nutritional-culinary intervention to produce beneficial effects on health parameters of overweight/obese patients and to compare the results obtained with the health effects obtained through a nutritional intervention without a culinary training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a randomized controlled trial design with one-month intervention program and six months of follow-up in order to test the effects of a culinary intervention program to improve cooking and healthy eating behaviour in overweight and obese patients. The culinary intervention program will be given over a one-month period, two days a week for four weeks. Participants in the control group (CG) will receive dietary training based on Mediterranean diet at the baseline visit and a leaflet explaining this dietary pattern. The participants assigned to the culinary intervention program will receive the same nutritional recommendations and eight online nutritional and cooking classes.
| Arm | Type | Receives |
|---|---|---|
| Nutritional education group (NEG) | Active comparator | Behavioral: Mediterranean diet-based nutritional education interventionParticipants in the nutritional education group will be given a leaflet with written nutrition educational information to follow a Mediterranean diet. Participants will be encouraged to adhere to this diet for one month. Four visits will be scheduled for participants assigned to this group: (1) before randomization (T1); (2) after randomization and before the the beginning of the intervention (T2); and (3) (4) after the intervention (T3)(T4). In all time-points, questionnaires will be registered and at T2 and T4 blood samples will be collected and advanced glycation end-products will be measured. |
| Culinary intervention group (CIG) | Experimental | Behavioral: Mediterranean diet-based culinary interventionParticipants assigned to the culinary intervention group will receive a written nutrition educational information as well as eight online nutritional and cooking classes during the one-month intervention period. Four visits will be scheduled for participants assigned to this group: (1) before randomization (T1); (2) after randomization and before the the beginning of the intervention (T2); and (3) (4) after the intervention (T3)(T4). In all time-points, questionnaires will be registered and at T2 and T4 blood samples will be collected and advanced glycation end-products will be measured. Participants will receive 8 culinary workshops between visit 2 and visit 3. In all time-points, questionnaires will be registered and at T2 and T4 blood samples will be collected and advanced glycation end-products will be measured. Volunteers will be also contacted by phone after 6 months of the end of the intervention to collect information about food and culinary habits. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight or obesity (BMI between 25 and 35 kg/m2)
- Low score in the screening questionaire "Homecooking Quality Index" (HQI)
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- Serious medical condition precluding dietary intervention or limiting survival to less than one year.
- Illicit drug use, chronic alcoholism.
- Participation in any clinical trial with drugs or dietary intervention during the year prior to inclusion.
- Weight loss intervention (surgical treatment, dietary or pharmacological treatment) during the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean diet-based nutritional education interventionThe patients in the nutritional intervention group will receive dietary advice on how to follow a Mediterranean diet. The dietary recommendations will be given at the beginning of the study by nutritionists using comprehensive written material. | Behavioural | Nutritional education group (NEG) |
| Mediterranean diet-based culinary interventionThe culinary intervention will be developed integrating eight culinary and nutritional workshops that will be given every week, twice per week, during one-month intervention. The duration of each culinary and nutritional workshop will be 1 hour, thus, the program will provide a total of hours of nutritional education and a total of 8 hours of nutritional and cooking training. The courses will take place in a well-equipped kitchen from the Basque Culinary Center and participants will be connected online in order to be able to cook and practice at the same time. All cooking classes will begin with a theoretical introductory part that aim to explain the main take-home messages from the workshop. Subsequently, every class will be characterized by a hands-on part that will include the demonstration and practical preparation of different elaborations based on the use specific cooking techniques and healthy ingredients. | Behavioural | Culinary intervention group (CIG) |
Primary outcome
Change in adherence to the Mediterranean Diet measured by Mediterranean Diet Adherence Screener (MEDAS)
Time frame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
At baseline, data about adherence to the Mediterranean Diet will be collected by a 14-point Mediterranean Diet Adherence Screener (MEDAS). 4 weeks post-baseline and 6 months post-baseline data from this questionnaire will be also collected. The MEDAS score can range from 0 to 14 and higher scores mean better outcome. - Unabbreviated scale title: Mediterranean Diet Adherence Screener
Change in the Frequency of Cooking Habits Questionnaire
Time frame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
At baseline, data about the Frequency of Cooking Habits will be collected by a 24-point questionnaire. 4 weeks post-baseline and 6 months post-baseline, data from this questionnaire will be also collected.
Change in the Confidence towards cooking Questionnaire
Time frame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
At baseline, data about the Confidence towards cooking will be collected by a 18-point questionnaire. 4 weeks post-baseline and 6 months post-baseline data from this questionnaire will be also collected. The Confidence towards cooking questionnaire can range from 18 to 90 and higher scores mean better confidence.
Change in the Attitude towards cooking Questionnaire
Time frame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
At baseline, data about the attitute towards cooking will be collected by a 18-point questionnaire. 4 weeks post-baseline and 6 months post-baseline data from this questionnaire will be also collected. The Attitude towards cooking questionnaire can range from 18 to 90 and higher scores mean better confidence
16 secondary outcomes
Change in biochemical parameters (Fasting glucose)
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (Fasting insulin)
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (Fasting total cholesterol)
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (Fasting HDL cholesterol)
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (Fasting LDL cholesterol)
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (C reactive protein levels)
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in biochemical parameters (TNFalpha)
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in advanced glycation end products (AGEs) level
Time frame: At baseline and after 4 weeks the beginning of intervention
Changes in body mass index (BMI)
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in fat mass
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in fat free mass
Time frame: At baseline and after 4 weeks the beginning of intervention
Changes in hip circumference
Time frame: At baseline and after 4 weeks the beginning of intervention
Changes in waist circumference
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in blood pressure
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in advanced glycation end products (AGEs) in tissue
Time frame: At baseline and after 4 weeks the beginning of intervention
Change in dietary intake measured by validated Food Frequency Questionnaire (FFQ)
Time frame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 33839905Zaharia OP, Kupriyanova Y, Karusheva Y, Markgraf DF, Kantartzis K, Birkenfeld AL, Trenell M, Sahasranaman A, Cheyette C, Kossler T, Bodis K, Burkart V, Hwang JH, Roden M, Szendroedi J, Pesta DH. Improving insulin sensitivity, liver steatosis and fibrosis in type 2 diabetes by a food-based digital education-assisted lifestyle intervention program: a feasibility study. Eur J Nutr. 2021 Oct;60(7):3811-3818. doi: 10.1007/s00394-021-02521-3. Epub 2021 Apr 11.
- Background: PubMed 31543284Irl B H, Evert A, Fleming A, Gaudiani LM, Guggenmos KJ, Kaufer DI, McGill JB, Verderese CA, Martinez J. Culinary Medicine: Advancing a Framework for Healthier Eating to Improve Chronic Disease Management and Prevention. Clin Ther. 2019 Oct;41(10):2184-2198. doi: 10.1016/j.clinthera.2019.08.009. Epub 2019 Sep 20.
- Background: PubMed 28024883Mills S, White M, Brown H, Wrieden W, Kwasnicka D, Halligan J, Robalino S, Adams J. Health and social determinants and outcomes of home cooking: A systematic review of observational studies. Appetite. 2017 Apr 1;111:116-134. doi: 10.1016/j.appet.2016.12.022. Epub 2016 Dec 23.
- Background: PubMed 28168012Abate G, Marziano M, Rungratanawanich W, Memo M, Uberti D. Nutrition and AGE-ing: Focusing on Alzheimer's Disease. Oxid Med Cell Longev. 2017;2017:7039816. doi: 10.1155/2017/7039816. Epub 2017 Jan 12.
- Background: PubMed 31561370Chou PS, Wu MN, Yang CC, Shen CT, Yang YH. Effect of Advanced Glycation End Products on the Progression of Alzheimer's Disease. J Alzheimers Dis. 2019;72(1):191-197. doi: 10.3233/JAD-190639.
- Individual participant dataSharing planned: No
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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Usune Etxeberria, PhD principal investigator
BCC Innovation (Basque Culinary Center Fundazioa)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet-based nutritional education intervention and Mediterranean diet-based culinary intervention in people with Obesity and Healthy Aging, run by Basque Culinary Center Fundazioa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adherence to the Mediterranean Diet measured by Mediterranean Diet Adherence Screener (MEDAS) (time frame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908163, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.