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Clinical Trials/NCT04449120
NCT04449120CompletedNot Applicable

HOME COOKING: Health Empowerment Strategy in People With Type II Diabetes Mellitus (SUKALMENA)

Basque Culinary Center Fundazioa2 sites in 1 country58 target enrollmentStarted: June 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
2
Primary Endpoint
Change in fasting insulin level

Study Overview

Brief Summary

Currently, one of the health challenges in the field of public health is to improve the quality of life of people with metabolic diseases, using new strategies that allow to promote healthy eating habits.

Within the new strategies that may encourage population improving eating habits, "HOMECOOKING" is proposed as a transforming tool for health, involving culinary skills and knowledge in nutrition. It is suggested as a new paradigm in nutritional education.

This project will cover the "HOMECOOKING: cooking and eating at home", as an innovative strategy, aiming to improve the quality of the diet of people with type II diabetes mellitus through an intervention based on cooking workshops. At these sessions, participants will learn easy cooking techniques and tools, in order to acquire culinary competences and to be empowered to prepare healthy dishes.

The effect of this intervention programme on the health of the participants will be evaluated through the measurement of biochemical parameters related to the disease (glycosylated haemoglobin, insulin, glucose, among others). In addition, specific compounds known as advanced glycation end products (AGEs) will be measured. The formation of these compounds is associated with the type of food consumed and the culinary techniques that are applied.

Detailed Description

One of the main factors influencing health is nutrition. Therefore, lifestyle and more specifically healthy eating habits, are key elements for the promotion of healthy lifestyle in society. Eating habits are defined as the more or less conscious, collective and repetitive behaviour that leads people to select, consume and use a certain foods or diet, in response to social and/or cultural influences. The acquisition of eating habits occurs since childhood. For this reason, an education in food and gastronomy is necessary to promote healthy eating habits in society. Education programmes so far have focused on nutrition education, i.e. on transferring theoretical knowledge about nutrition. However, currently, it is known that traditional knowledge about nutrition is not sufficient and it is necessary to go deeper into the factors that determine what people eat, and how people eat.

The studies related to the sensory perception of food and the relationship that this perception has with the choice of food, seek to decipher the keys that make different individuals to have certain eating habits based on: personal tastes, the influence of culture, the emotions that make them feel, learning, and so on. Nutritional recommendations will always be simpler to follow when, implicit in them, the tastes and food choices of each individual are found.

From a holistic perspective, individuals should be considered as a human being within a social, cultural and technological environment. In this sense, gastronomy is defined as "the reasoned knowledge of what people eat and how people eat. It is an interdisciplinary area of knowledge that studies and generates physical-chemical, cultural and socioeconomic processes where human beings cultivate, process, distribute and consume good foods and beverages that affect their physical, mental and social well-being". Gastronomy is a vehicle capable of creating social trends and the convergence of this discipline together with nutritional education can be a more effective tool to disseminate messages about what is considered a healthy diet, how to eat a healthy diet, as well as to transfer cooking skills that allow the population to acquire and sustain these eating habits at home.

Briefly, gastronomy plays a fundamental role in covering the nutritional needs of the general population, and at the same time, it satisfies their expectations of flavour. Therefore, gastronomy is considered a decisive channel to favour education of taste, a better nutrition and, in general, for health promotion.

The effect of nutrition on health is not homogeneous in the population. On the one hand, factors such as the type of food and the culinary techniques used have an influence. On the other hand, individual characteristics such as lifestyle, genetic background and wellbeing must be taken into account. In this context, Personalized and Precision Gastronomy based on individuals' eating habits, genetic profile, intestinal microbiota profile, metabolome, epigenome, tastes and preferences, and so on, in order to develop strategies that favour a healthy and tailor-made diets for each individual.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with type 2 Diabetes Mellitus without treatment with insulin, sulfonylureas and glinides.
  • Overweight or obesity (BMI between 25 and 40 kg/m2).
  • Stable treatment with oral antidiabetics, other than sulfonylureas or glinides, at least for 3 months.

Exclusion Criteria

  • Treatment with insulin, sulfonylureas or glinides
  • Glycosylated hemoglobin (HbA1c) concentration greater than 10%
  • Weight loss exceeding 5 kg in the past three months
  • Pregnant or breastfeeding women
  • Serious medical condition that impedes from conducting the dietary intervention or that limits the survival to less than one year
  • Consumption of illegal drugs, chronic alcoholism or alcohol total consumption above 80 g/day
  • Participation in other clinical trial with drugs or nutritional intervention during the previous year to inclusion
  • Major difficulties or inconveniences in changing dietary habits and following the Mediterranean Diet (allergies, intolerances)
  • Difficulties for regular home cooking and/or eating out more than 2 days per week
  • Current diagnosis of an eating disorder, schizophrenia, other psychotic disorder or bipolar disorder
  • Hospitalization for any mental illness in the previous year
  • History of bariatric surgery or extensive bowel resection

Outcomes

Primary Outcomes

Change in fasting insulin level

Time Frame: Baseline; three months follow-up

At baseline blood samples will be collected for determination of fasting insulin levels. At 3 months of follow-up, the determination of this parameter will be repeated.

Change in fasting glycosylated hemoglobin level

Time Frame: Baseline; three months follow-up

At baseline blood samples will be collected for determination of hemoglobin A1c. At 3 months of follow-up, the determination of this parameter will be repeated.

Change in fasting glucose level

Time Frame: Baseline; three months follow-up

At baseline blood samples will be collected for determination of fasting glucose levels. At 3 months of follow-up, the determination of this parameter will be repeated.

Secondary Outcomes

  • Changes in hip circumference(Baseline; three months follow-up)
  • Change in plasma C-reactive protein(Baseline; three months follow-up)
  • Change in advanced glycation end products (AGEs) level(Baseline; three months follow-up)
  • Changes in waist circumference(Baseline; three months follow-up)
  • Changes in body mass index (BMI)(Baseline; three months follow-up)
  • Change in fat mass(Baseline; three months follow-up)
  • Change in fat free mass(Baseline; three months follow-up)
  • Changes in lipid metabolism parameters(Baseline; three months follow-up)
  • Change in blood pressure(Baseline; three months follow-up)
  • Change in dietary intake measured by validated Food Frequency Questionnaire (FFQ)(Baseline; three months follow-up)
  • Change in adherence to the Mediterranean Diet measured by Mediterranean Diet Adherence Screener(Baseline; one month; three months follow-up)
  • Change in quality of life measured by Quality of Life Questionnaire(Baseline; three months follow-up)
  • Change in physical activity level measured by the Minnesota Leisure-Time Physical Activity Questionnaire(Baseline; three months follow-up)
  • Change in culinary habits measured by Culinary Habits Frequency Questionnaire (CHFC)(Baseline; three months follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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