Clinical trial NCT04908163: Sukalmena InAge: Nutritional-culinary Programme to Promote Adherence to a Healthy Dietary Pattern.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Healthy Aging
Cognitive Impairment
Keywords: Mediterranean diet
Culinary intervention
Cooking classes
Nutritional education
Confidence
Lead sponsor: Basque Culinary Center Fundazioa
Sponsor class: OTHER
Collaborators: name: University of Navarra
First posted: 2021-06-01
Enrollment: 56
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Overweight or obesity (BMI between 25 and 35 kg/m2)
* Low score in the screening questionaire "Homecooking Quality Index" (HQI)

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in adherence to the Mediterranean Diet measured by Mediterranean Diet Adherence Screener (MEDAS)
timeFrame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
measure: Change in the Frequency of Cooking Habits Questionnaire
timeFrame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
measure: Change in the Confidence towards cooking Questionnaire
timeFrame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
measure: Change in the Attitude towards cooking Questionnaire
timeFrame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
Secondary outcomes:
measure: Change in biochemical parameters (Fasting glucose)
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in biochemical parameters (Fasting insulin)
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in biochemical parameters (Fasting total cholesterol)
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in biochemical parameters (Fasting HDL cholesterol)
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in biochemical parameters (Fasting LDL cholesterol)
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in biochemical parameters (C reactive protein levels)
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in biochemical parameters (TNFalpha)
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in advanced glycation end products (AGEs) level
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Changes in body mass index (BMI)
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in fat mass
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in fat free mass
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Changes in hip circumference
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Changes in waist circumference
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in blood pressure
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in advanced glycation end products (AGEs) in tissue
timeFrame: At baseline and after 4 weeks the beginning of intervention
measure: Change in dietary intake measured by validated Food Frequency Questionnaire (FFQ)
timeFrame: At baseline, after 4 weeks the beginning of intervention and after 6 months the beginning of intervention
Other outcomes:
Locations:
city: Donostia-San Sebastián
country: Spain
facility: Basque Culinary Center Fundazioa
state: Gipuzkoa
Study officials:
affiliation: BCC Innovation (Basque Culinary Center Fundazioa)
name: Usune Etxeberria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Abate 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.
citation: Chou 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.