CIRFD Universidad Pablo de Olavide
Seville, 41013, Spain
NCT Number: NCT05713461
This project aims to develop an intervention on healthy habits based on physical exercise and nutritional education in people with obesity.
It is accepted that exercise and nutrition are keys to controlling body weight. People with obesity frequently present with metabolic syndrome and a low-grade inflammatory state.
It is not known what should be the most effective training load/dose (duration, intensity, type of exercise) to improve health indicators related to metabolic syndrome and lipo-inflammation, and body composition in people with obesity.
A large-scale randomized controlled trial (RCT) will be essential to better understand the type and characteristics of training load/dose most effective in counteracting the detrimental effects of obesity.
The aim of this trial in 50 obese women was to answer the following questions:
* Does the training program improve physical fitness? * Does the training program improve body composition? * Does the training program improve the state of chronic low-grade inflammation? * Does the training program improve the quality of life and perceived health? * Do people with obesity and metabolic syndrome respond in the same way to training? * what is the effect of four weeks of detraining?
Looking for future studies?
Notify Me35 year–65 year
Female
Interventional
Not applicable
Seville, 41013, Spain
A female single group, 2-armed ( people with obesity and metabolic syndrome vs people with obesity without metabolic syndrome), investigator-blinded, trial.
The study will last 17 weeks. Week 1 (testing 1: pretest); weeks 2-11 (Intervention: interval training program); week 12 (testing 3: postest); weeks 13-16 (detraining period); week 17 (testing 3: detraining test)
Participants will be allocated (1:1) regarding metabolic syndrome Behavioural: exercise training program Adapted Interval Training Intervention, three days a week, 10 weeks.
Warm-up ≃ 10': Joint mobility and cardiovascular activation.
Main part ≃ 45 min.:
Resistance training circuit for strengthening the main muscle groups.
The training load will increase while maintaining the same intensity.
Cool down ≃ 5' Flexibility and CORE
Behavioural: Feeding training Two workshops on healthy eating habits (Week 1 and week 5). Food Frequency Questionnaires (weekly). Feedback weekly Mediterranean Diet Adherence Screener (MEDAS) The dietary intervention will be based on the nutritional recommendations based on the Mediterranean diet, according to the evidence from the PREDIMED trial.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Main inclusion criteria
Exclusion criteria
Adapted Interval Training Intervention, three days a week, 10 weeks.
Warm-up 10': Joint mobility and cardiovascular activation
Main part:
Resistance training circuit for strengthening the main muscle groups.
Cool down Flexibility and CORE
Other names: interval training program
Two workshops on healthy eating habits (Week 1 and week 5). Food Frequency Questionnaires (weekly). Feedback weekly. Mediterranean Diet Adherence Screener (MEDAS). The dietary intervention will be based on the nutritional recommendations based on the Mediterranean diet, according to the evidence from the PREDIMED trial.
Time frame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Plasma levels of inflammatory and lipoinflammatory markers
Multiplex Quantitative measurement of 40 human adipokines in plasma (cytokine antibody arrays (pg/ml) :
Time frame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Body composition by DEXA. Main body composition components:
Time frame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Time frame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Aerobic power. VO2 max. (estimated from the 6-minute walk test; ml/kg/min)
Time frame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Balance test one leg (seconds)
Time frame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
perceived health by questionnaire (SF-12). The SF-12 response options are Likert-type scales that assess intensity or frequency.
The number of response options ranges from three to six, depending on the item, and each question receives a value that is later transformed into a scale from 0 to 100.
Time frame: from baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Mediterranean Diet Adherence Screener (MEDAS). MEDAS consists of 12 questions on food consumption frequency and 2 questions on food intake habits considered characteristic of the Spanish Mediterranean diet. Each question was scored 0 or 1.
Time frame: Every week, from baseline (0 weeks) to follow-up (10 weeks)
Food Frequency Questionnaires (weekly). Recording the frequency of food consumption per week
Time frame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
LIPIDIC PROFILE Total Cholesterol (mg/dl) HDL Cholesterol (mg/dl) LDL Cholesterol (mg/dl) Triglycerides (mg/dl)
Time frame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
Glycosylated Hemoglobin A1c (%) Insulin (uU/ml) Glucose (mg/dl) Insulin Resistance. HOMA-IR = (fasting insulin (uU/ml) * fasting glucose (mg/dl)) / 405
Time frame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
ENZYMES (Fatigue or muscular damage) Creatine Kinase (UI/L) Transaminases (GOT/AST, GPT/ALT, GGT; UI/L ) C-Reactive Protein (mg/l)
Time frame: From baseline ( 0 weeks) to follow-up (10 weeks) and detraining effects (after 4 weeks sedentary lifestyle)
PROTEIN METABOLISM Uric Acid (mg/dl) Urea (mg/dl) Creatinine (mg/dl) Bilirubin (mg/dl)
Universidad Pablo de Olavide
Other
Effects of a Physical Exercise Program Adapted to People With Obesity on Health Indicators and Quality of Life.
Acronym: OBEFYSA
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