Efficacy of a Nutritional Education Strategy and Physical Exercise on the Gut Microbiota in Type 2 Diabetics
NCT ID: NCT05261373
Last Updated: 2022-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-03-10
2024-08-31
Brief Summary
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The project is a randomized controlled clinical trial in 120 participants with T2DM and obesity, which aims to determine the efficacy of a nutritional education program and the role of physical exercise type on health related variables. The participants will be of both sexes with age between 40 and 55 years, belonging to the Province of Cádiz. The design has two 12-week interventions; the main factor has 2 levels: participants who receive the nutritional education (EDU) and controls (CG); the second factor has 3 levels: high-intensity interval training (HIIT), moderate intensity continuous training (MICT), and controls (INACT). Therefore, participants will be randomized into 6 groups (n=20), adjusted by gender (≈50% in each group): EDU+HIIT, EDU+MICT, EDU+INACT, CG+HIIT, CG+MICT, CG+INACT.
The outcome variables, which will be measured before and after the intervention, will include: dietary intake assessment, physical activity assessment, quality of life, faecal samples, blood samples, blood pressure, appetite assessment, muscle biopsy samples, body composition and fluids, basal metabolism, maximal fat oxidation test and cardiorespiratory fitness.
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Detailed Description
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Improving the implementation of health-related education programs is a key tool for behaviour change; however, not all education supports behavioural change. The terms education and knowledge are often thought of interchangeably. Nevertheless, while knowledge is defined as "facts, information, and skills acquired by a person through experience or education", education is a comprehensive term that can be defined as "the process of receiving or giving systematic instruction" or as "an enlightening experience". Therefore, interventions should attempt the education achievement in order to improve healthy lifestyles and reduce diabetes prevalence, complications and morbimortality. In this line, the impact of nutritional counselling on weight reduction, glycaemia control, and improve of health in obese and diabetes population have been previously study with inconsistent results. Thus, education strategies should be optimized to achieve behaviour changes related to nutrition and physical exercise.
Recently it has been discover than gut microbiota can modulate behaviour, including nutritional behaviour and decisions, therefore, gut microbiota can have an impact on the efficacy of an education program. Gut microbiota is composed of more than 100 billion microorganisms classified in at least 1000 different species of bacteria, fungi, viruses and yeasts. In light of these considerations, Nobel laureate Joshua Lederberg proposed to consider the microbiota, especially the intestinal one, as a "superorganism". One of the great findings in neuroscience is the connection of the intestinal microbiota and the brain, called gut-brain axis, telling us whether to eat or not, even what food (for example the desire to eat something sweet or salty). These results can be a great advance for the area of education and behavioural sciences, especially of those education program focused on improve nutritional habits.
Moreover, even maintaining similar energy intake through diet and similar physical activity levels, a healthy change of gut microbiota is able to reduce body fat percentage, what has a positive impact on the prevention and treatment of T2DM. Therefore, educational programs focused on improving gut microbiota can be a useful tool to respond to the Global Plan of Action on Non-communicable Diseases, and could reduce the failure of some weight loss educational strategies and programs. Recently it has been shown that gut microbiota plays a significant role in the pathophysiology of T2DM modulating the secretion of insulin and glucose. Therefore, tools that establish the microbiota should be promoted, such as nutritional restoration strategies, through prebiotics and probiotics, in obesity and T2DM populations as we have previously study.
In addition, physical exercise seems to improve gut microbiota composition, specifically the Firmicutes spp. / Bacteroidetes spp. ratio, additionally, a positive correlation has been found between Lactobacillus spp. and Bifidobacterium spp. with serum leptin levels in trained rats. Most exercise programs to combat obesity have been based primarily on aerobic exercises. Aerobic training is associated with a decrease in body fat mass, especially visceral fat mass, increases insulin sensitivity, lowers baseline glucose and insulin levels, and increases the expression of glucose and fatty acid transport proteins in muscle fibres. Workouts that are performed at the intensity at which the person burns more fat (FatMax) seems to reduce body fat and insulin resistance in older women with type 2 diabetes. However, the time taken for these training sessions is approximately 60-90 minutes a day.
According to previous scientific research, we hypothesize that the combination of a nutritional education intervention with a HIIT-based physical exercise program improve muscle metabolism through positive modifications of gut microbiota in people with T2DM, leading to better glycaemia/insulinaemia levels, reduction of body fat mass and improving quality of life.
The project is a randomized controlled clinical trial in 120 participants with T2DM and obesity, which aims to determine the efficacy of a nutritional education program and the role of physical exercise type on health related variables. The participants will be of both sexes with age between 40 and 55 years, belonging to the Province of Cádiz. The design has two 12-week interventions; the main factor has 2 levels: participants who receive the nutritional education (EDU) and controls (CG); the second factor has 3 levels: high-intensity interval training (HIIT), moderate intensity continuous training (MICT), and controls (INACT). Therefore, participants will be randomized into 6 groups (n=20), adjusted by gender (≈50% in each group): EDU+HIIT, EDU+MICT, EDU+INACT, CG+HIIT, CG+MICT, CG+INACT.
The outcome variables, which will be measured before and after the intervention, will include: dietary intake assessment, physical activity assessment, quality of life, faecal samples, blood samples, blood pressure, appetite assessment, muscle biopsy samples, body composition and fluids, basal metabolism, maximal fat oxidation test and cardiorespiratory fitness.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control (CG+INACT)
Participants who do not receive neither nutritional education nor exercise program. They will be instructed to maintain their normal life habits with respect to physical activity and diet.
No interventions assigned to this group
Moderate-intensity continuous training (CG+MICT)
Participants who do not receive nutritional education but are enrolled in a moderate-intensity continuous training exercise program.
The Moderate-Intensity Continuous Training (MICT)
3 sessions per week in a cycle ergometer, with 1-2 days off between sessions, during a total of 12 weeks under the supervision of a personal trainer. MICT program will consist of sessions of approximately ˜45 min of moderate aerobic exercise (at the intensity at which the maximal fat oxidation was achieved in the laboratory test) in cycle ergometer.
High-intensity interval training (CG+HIIT)
Participants who do not receive nutritional education but are enrolled in a high-intensity interval training exercise program.
The High-Intensity Interval Training (HIIT)
3 sessions per week in a cycle ergometer, with 1-2 days off between sessions, during a total of 12 weeks under the supervision of a personal trainer. HIIT program will consist of 3-5 series of 1 min duration at 90-130% of its maximum power (determined in the first training session), with 90 seconds of rest between sets (estimated total time of the session: 10 minutes). Depending on the number of training session, the load and the series will increase up to 40% more than the maximum load.
Nutritional Education (EDU+INACT)
Participants who receive nutritional education but not an exercise program.
Behavioral: Nutritional education program
The education intervention will consist of individual nutritional counselling. The nutritional education program will be conducted every 2 weeks for 12 consecutive weeks, with 20-min counselling sessions by an experienced nutritionist. Participants will be provided with an introduction (in an easy-to-understand manner) regarding the association between T2DM, gut microbiome and dietary habits. Firstly, the diet of the patient should be analysed, to determine which aspects can be improved, such as, total calories intake, amount and types of carbohydrates (highlighting the relevance of fibre), etc. Moreover, some suggestions about the combination of foods and culinary technical in order to manage the glycaemic index of foods will be provided. Finally, those pattern of the Mediterranean diet and some qualitative aspects and aids (as the size of the plat or avoid having the food platter on the table) will be taught the patients.
Nutritional Education Moderate-intensity continuous training (EDU+MICT)
Participants who receive nutritional education and are enrolled in a moderate-intensity continuous training exercise program.
The Moderate-Intensity Continuous Training (MICT)
3 sessions per week in a cycle ergometer, with 1-2 days off between sessions, during a total of 12 weeks under the supervision of a personal trainer. MICT program will consist of sessions of approximately ˜45 min of moderate aerobic exercise (at the intensity at which the maximal fat oxidation was achieved in the laboratory test) in cycle ergometer.
Behavioral: Nutritional education program
The education intervention will consist of individual nutritional counselling. The nutritional education program will be conducted every 2 weeks for 12 consecutive weeks, with 20-min counselling sessions by an experienced nutritionist. Participants will be provided with an introduction (in an easy-to-understand manner) regarding the association between T2DM, gut microbiome and dietary habits. Firstly, the diet of the patient should be analysed, to determine which aspects can be improved, such as, total calories intake, amount and types of carbohydrates (highlighting the relevance of fibre), etc. Moreover, some suggestions about the combination of foods and culinary technical in order to manage the glycaemic index of foods will be provided. Finally, those pattern of the Mediterranean diet and some qualitative aspects and aids (as the size of the plat or avoid having the food platter on the table) will be taught the patients.
Nutritional Education High-intensity interval training (EDU+HIIT)
Participants who receive nutritional education and are enrolled in a high-intensity interval training exercise program.
The High-Intensity Interval Training (HIIT)
3 sessions per week in a cycle ergometer, with 1-2 days off between sessions, during a total of 12 weeks under the supervision of a personal trainer. HIIT program will consist of 3-5 series of 1 min duration at 90-130% of its maximum power (determined in the first training session), with 90 seconds of rest between sets (estimated total time of the session: 10 minutes). Depending on the number of training session, the load and the series will increase up to 40% more than the maximum load.
Behavioral: Nutritional education program
The education intervention will consist of individual nutritional counselling. The nutritional education program will be conducted every 2 weeks for 12 consecutive weeks, with 20-min counselling sessions by an experienced nutritionist. Participants will be provided with an introduction (in an easy-to-understand manner) regarding the association between T2DM, gut microbiome and dietary habits. Firstly, the diet of the patient should be analysed, to determine which aspects can be improved, such as, total calories intake, amount and types of carbohydrates (highlighting the relevance of fibre), etc. Moreover, some suggestions about the combination of foods and culinary technical in order to manage the glycaemic index of foods will be provided. Finally, those pattern of the Mediterranean diet and some qualitative aspects and aids (as the size of the plat or avoid having the food platter on the table) will be taught the patients.
Interventions
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The Moderate-Intensity Continuous Training (MICT)
3 sessions per week in a cycle ergometer, with 1-2 days off between sessions, during a total of 12 weeks under the supervision of a personal trainer. MICT program will consist of sessions of approximately ˜45 min of moderate aerobic exercise (at the intensity at which the maximal fat oxidation was achieved in the laboratory test) in cycle ergometer.
The High-Intensity Interval Training (HIIT)
3 sessions per week in a cycle ergometer, with 1-2 days off between sessions, during a total of 12 weeks under the supervision of a personal trainer. HIIT program will consist of 3-5 series of 1 min duration at 90-130% of its maximum power (determined in the first training session), with 90 seconds of rest between sets (estimated total time of the session: 10 minutes). Depending on the number of training session, the load and the series will increase up to 40% more than the maximum load.
Behavioral: Nutritional education program
The education intervention will consist of individual nutritional counselling. The nutritional education program will be conducted every 2 weeks for 12 consecutive weeks, with 20-min counselling sessions by an experienced nutritionist. Participants will be provided with an introduction (in an easy-to-understand manner) regarding the association between T2DM, gut microbiome and dietary habits. Firstly, the diet of the patient should be analysed, to determine which aspects can be improved, such as, total calories intake, amount and types of carbohydrates (highlighting the relevance of fibre), etc. Moreover, some suggestions about the combination of foods and culinary technical in order to manage the glycaemic index of foods will be provided. Finally, those pattern of the Mediterranean diet and some qualitative aspects and aids (as the size of the plat or avoid having the food platter on the table) will be taught the patients.
Eligibility Criteria
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Inclusion Criteria
* Non-alcoholic (\<3 standard drinks per day)
* Body mass index \>25 kg/m maintaining the habitual dietary patterns without a body mass reduction higher than 2% during the last 6 months
* Not being insulin dependent
* Absence of injury, disease or disability or other known medical condition which could affect the ability to successfully participate in physical exercise tests
* Absence of cardiovascular disease (angina, peripheral or cerebro-vascular disease, etc.).
* Absence of neurologic and psychiatric diseases.
* Absence of respiratory diseases (pulmonary hypertension, Chronic obstructive pulmonary disease, etc.).
* Absence of other metabolic diseases (hyper/hypo parathyroidism, hyper/hypothyroidism, Cushing's disease, Type 1 diabetes, etc.)
* Absence of active inflammatory bowel disease
* Absence of kidney disease
* Absence of tumours
* Absence of coagulation dysfunction
* Not under treatment with medications k known to affect glucose metabolism, recent steroid treatment (within 6 months), or hormone replacement therapy
* Be able to understand a communication in Spanish or English.
Exclusion Criteria
* The lose more than 4 or 6 sessions in total of nutritional counselling or physical training respectively.
40 Years
55 Years
ALL
No
Sponsors
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Ministerio de Ciencia e Innovación, Spain
OTHER_GOV
University of Cadiz
OTHER
Responsible Party
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Principal Investigators
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Jesús Gustavo Ponce González, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cádiz
Cristina Casals, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cádiz
Locations
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Facultad de Ciencias de la Educación
Puerto Real, Cadiz, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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The EDUGUTION project
Identifier Type: -
Identifier Source: org_study_id
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