Sukalmena InAge: Nutritional-culinary Programme to Promote Adherence to a Healthy Dietary Pattern.

NCT04908163 | Completed

• 1 other identifier: PI2021067
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Healthy Aging; Cognitive Impairment

Keywords

Mediterranean diet; Culinary intervention; Cooking classes; Nutritional education; Confidence

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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

  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 and after 4 weeks the beginning of intervention

• Change in biochemical parameters (Fasting insulin)

  At baseline and after 4 weeks the beginning of intervention

• Change in biochemical parameters (Fasting total cholesterol)

  At baseline and after 4 weeks the beginning of intervention

• Change in biochemical parameters (Fasting HDL cholesterol)

  At baseline and after 4 weeks the beginning of intervention

• Change in biochemical parameters (Fasting LDL cholesterol)

  At baseline and after 4 weeks the beginning of intervention

Study Arms (2)

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.

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.

Behavioral: Mediterranean diet-based culinary intervention

Interventions

Mediterranean diet-based nutritional education intervention BEHAVIORAL

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.

Nutritional education group (NEG)

Mediterranean diet-based culinary intervention BEHAVIORAL

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.

Culinary intervention group (CIG)

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating women.
• Serious medical condition precluding dietary intervention or limiting survival to less than one year.
• Illicit drug use, chronic alcoholism.
• 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).

Sponsors & Collaborators

• Basque Culinary Center Fundazioa: lead
• University of Navarra: collaborator

Study Sites (1)

Basque Culinary Center Fundazioa

Donostia / San Sebastian, Gipuzkoa, 20009, Spain

Location

Related Publications (5)

• 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.

  PMID: 33839905 BACKGROUND

• Irl 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.

  PMID: 31543284 BACKGROUND

• Mills 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.

  PMID: 28024883 BACKGROUND

• 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.

  PMID: 28168012 BACKGROUND

• 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.

  PMID: 31561370 BACKGROUND

MeSH Terms

Conditions

Obesity; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Usune Etxeberria, PhD

  BCC Innovation (Basque Culinary Center Fundazioa)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: May 26, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)