Metabolic SyndromeNCT01793896
Beneficial Effects of Exercise and Healthy Diets on Muscle and Adipose Tissue
A study testing Diet Group, Exercise group and Diet + Exercise in people with Metabolic Syndrome, run by University of Chile at 1 site in Chile.
Trial summary
Both dietary caloric restriction (CR) and physical exercise (PE) exert beneficial effects, which retard or prevent age-related diseases and prolong life span. Subjects with the metabolic syndrome age prematurely, therefore preventive measures should be initiated early. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Diet Group, Exercise group and Diet + Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteChile
- Study dates
- Jul 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- CROSS SECTIONAL: male sex, age 25 -50 years, with BMI ranging from 20 to 35 kg/mt2. INTERVENTION STUDY: Overweight or obese men and women aged 25 - 50 years interested in losing weight,will
Who cannot join
- CROSS SECTIONAL : diabetes mellitus, chronic neuromuscular or neurological deficits precluding normal physical activity, heavy smoking (> 5 cigarettes per day), alcohol intake > 30 g/day and chronic diseases such as cancer, HIV-AIDS, renal, pulmonary, cardiac or hepatic conditions.
- INTERVENTION STUDY: weight fluctuations (> 3 k in the last 3 months), diabetes mellitus, chronic neuromuscular or neurologic diseases, heavy smoking (> 5 cigarettes per day) and alcohol intake > 30 g/day, and chronic diseases such as cancer, HIV, renal, pulmonary, cardiac or hepatic conditions.
- -
Trial locations and contacts
1 site in 1 country.
Chile1 site
Institute of Nutrition & Food Technology (INTA)
Santiago, Metropolitan Region, 7830490
About this study
Official title: Mitochondrial Biogenesis, Reduction of Muscle Oxidative Damage and Improvement in Adipose Tissue Functional Profile, Account for the Beneficial Effects of Exercise and Healthy Diets
Both dietary caloric restriction (CR) and physical exercise (PE) exert beneficial effects, which retard or prevent age-related diseases and prolong life span. Subjects with the metabolic syndrome age prematurely, therefore preventive measures should be initiated early. The present study intends to demonstrate that physical exercise and/or Mediterranean diet, in middle aged volunteers with the metabolic syndrome, preserve adequate adipose tissue functionality and retard skeletal muscle aging (assessed by mitochondrial biogenesis and accumulation of ROS), by activating several pathways, homologous to CR. The investigators plan to study this by using two approaches: 1) A cross- sectional model, in which the expression of the mentioned metabolic mediators, indicators of muscle mitochondrial biogenesis and muscle oxidative damage will be compared between men with different body compositions, fat distribution, muscle strength and exercise capacity (VO2max). Also, in these men the investigators will assess the expression of uncoupling protein 1 (UCP1) in subcutaneous white adipose tissue (as a measure of adaptive thermogenesis), and inflammatory markers (Interleukin 1-6, Interleukin 1ß and CCL2 chemokine (C-C motif ligand 2)) in preperitoneal adipose tissue, plus inflammation and adipogenesis potential of their cultured preadipocytes. Moreover, in vitro studies will evaluate the functional effects of exposure of a cell lyne of human adipocyte cells (LS14)to factors secreted by media conditioned by the patients´ adipose tissue explants. 2) A prospective intervention in overweight/moderately obese middle aged volunteers that will be assigned to a weight-maintenance period (as a control group), and then randomly y assigned to a Mediterranean diet, exercise training or diet plus training. Before and after 3 months of intervention the investigators will obtain muscle tissue samples to study the expression of Peroxisome proliferator activated receptor (PPAR) gamma coactivator 1 alpha (PGC1), uncoupling protein 3 (UCP3), AMP activated protein kinase (AMPK), Sirtuin 1 (SIRT-1), mitochondrial DNA and oxidative damage indicators (8-oxo-7,8-dihydro-2-deoxyguanosine (oxodG), carboxymethyllysine (CML and its receptor (RAGE)). In vitro studies will evaluate the effect of circulating factors from the patients (serum) on LS14 inflammatory and adipogenic potential, at baseline and after 3 months of intervention.
Read the detailed description
METHODOLOGY:
This study will be composed of 2 parts:
I - CROSS SECTIONAL STUDY The aim of this section is to compare men with different body compositions, fat distribution and exercise capacity with respect to their muscle mitochondrial biogenesis, oxidative damage and energy flux regulator molecules, together with their adipose tissue inflammation, adipokine expression and thermogenic potential.
Inclusion criteria :
- male sex
- age 25 - 50 years
- BMI from 20 - 35 kg/mt2
- indication for surgery of an inguinal hernia
Exclusion criteria:
- diabetes mellitus
- chronic neuromuscular or neurological deficits precluding normal physical activity
- heavy smoking (> 5 cigarettes per day)
- alcohol intake > 30 g/day
- chronic diseases such as cancer, HIV-AIDS, renal, pulmonary, cardiac or hepatic conditions.
Before the operation and after signing a written informed consent, the following assessment will be performed:
- Medical history including medication intake and complete physical examination.
- Dietary recall of habitual intake and calculation of AGEs ingestion.
- Regular physical activity assessment using the International Physical Activity Questionnaire
- Anthropometrics (height, weight, waist circumference)
- Fasting blood sampling for routine determinations (haemoglobin,lipoproteins, creatinine,prothrombin, TSH), AGEs concentrations (CML) free fatty acids, adiponectin and 8- Isoprostanes.
- Fasting and post glucose serum sampling for glucose and insulin measurements, and calculation of Homeostasis Model Assessment (HOMA-IR) and the Matsuda Index for determination of peripheral insulin sensitivity.
- Resting and exercise indirect calorimetry for estimation of resting energy expenditure, respiratory quotient and VO2 max.
- Handgrip and quadriceps muscle strength
- Dual X-Ray Energy Densitometry (DEXA) for estimation of body composition
- CT scan of abdominal region at L4 level for measurement of visceral and subcutaneous fat areas and estimation of liver fat infiltration.
- Ultrasound intensity analysis in thigh ultrasonography indicating muscle fat infiltration. After the initial evaluation, subjects will be classified as with or without the metabolic syndrome, according to the international guidelines guidelines, for further analysis of data.
A few days later, during the surgical procedure, a sample of muscle tissue (approximately 200 mg of internal abdominal oblique) will be obtained for measurement of:
- Fiber type
- Messenger Ribonucleic acid (mRNA) expression of PGC-1-alpha, SIRT-1, UCP-3 and AMPK
- Mitochondrial density by measurement of mitDNA and Cytochrome C activity
- Oxidative damage (8-oxodG, CML and RAGE).
During the same operation, 2 samples of adipose tissue will also be obtained, one subcutaneous (at the site of the incision) and the other preperitoneal (at the inguinal sac), for in vitro studies:
- UCP1 and inflammatory marker (interleukin 6, 1ß, CCL2) expression in mature adipocytes
- Inflammatory profile and adipogenic potential (expression of lipoprotein lipase, PPAR gamma and adiponectin) in cultured preadipocytes
- Adipogenic potential and inflammatory expression profile of LS14 adipose cells exposed to conditioned media from adipose tissue explants.
A small part of these adipose tissue samples will be placed in formaldehyde, fixed and stained with H.E for histologic estimation of adipocyte cell size.
II - INTERVENTION STUDY This section intends to demonstrate the effects of a low-AGEs Mediterranean diet and/or exercise, over skeletal muscle metabolic profile and adipogenic/inflammatory features of adipocytes.
Inclusion criteria:
- Overweight or obese men and women
- Ages 25 - 50 years
- Interest in losing weight
Exclusion criteria:
- weight fluctuations (> 3 k in the last 3 months)
- diabetes mellitus
- chronic neuromuscular or neurologic diseases
- heavy smoking (> 5 cigarettes per day)
- alcohol intake > 30 g/day
- chronic diseases such as cancer, HIV, renal, pulmonary, cardiac or hepatic conditions.
Subjects will be invited to participate in a trial using a Mediterranean low-AGEs diet and/or physical exercise during 3 months. After signing a written informed consent,subjects will be allocated to one of these interventions, which will be randomly selected, and the following assessment will be performed, at baseline and after 3 months of intervention:
- Medical and medication intake history and complete physical examination.
- Dietary recall of habitual intake and calculation of AGEs ingestion.
- Physical activity questionnaire (IPAQ)
- Anthropometrics (height, weight, waist circumference)
- Fasting blood sampling for routine determinations (haemoglobin, lipoproteins, creatinine, prothrombin and TSH), AGEs concentrations (CML), free fatty acids, adiponectin, 8-Isoprostanes and serum for in vitro adipose tissue studies (see below).
- Fasting and post glucose blood sampling for glucose and insulin measurements, and calculation of HOMA-IR and the Matsuda Index for determination of peripheral insulin sensitivity.
- Dual X-Ray Energy Densitometry (DEXA) for estimation of body composition
- CT scan of abdominal region at L4 level for measurement of visceral and subcutaneous fat areas and estimation of liver fat infiltration
- Resting and exercise indirect calorimetry for estimation of resting energy expenditure, respiratory quotient and VO2 max.
- Handgrip and quadriceps muscle strength
- Ultrasound intensity analysis in thigh indicating muscle fat infiltration
- Ultrasound guided quadriceps muscle biopsy to measure mitochondrial density (mitDNA) and expression of PGC-1
- Conditions
- Metabolic Syndrome
- Being tested
- Control period, Diet Group, Exercise group, Diet + Exercise
- Keywords
- Metabolic syndrome, Ageing, Mitochondrial density, Oxidative damage, Inflammatory mediators, AMPK, Adipogenesis
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control periodBehavioural
Also called Before randomization
Analysis at recruitment and after a month without any intervention
Diet GroupBehavioural
Also called Mediterranean diet
selected subjects will adopt a Mediterranean low-AGE diet. We will not include red wine in the Mediterranean diet (7 Kilocalories (KCal)/g), in order to attain more weight loss. Each subject will be instructed to reduce 500 Kcal of their estimated total daily energy requirements, so theoretically they will be able to reduce 5 - 10 % of their body weight in 3 months.
Exercise groupBehavioural
The intervention will consist of 3 weekly 1 hour sessions (5 minutes of preconditioning, followed by 20 minutes cycling, brisk walking or jogging at 65-70 % maximal aerobic capacity, then 25 minutes resistance weight-lifting exercises and finally 10 minutes of stretching). Exercise intensity will be increased weekly according to the Borg Scale intensity. The exercise intervention will be supervised by physical education teachers, registering attendance at every session.
Diet + ExerciseBehavioural
these patients will be incorporated to receive both Mediterranean diet plus exercise interventions
| Study group | Role | What they receive |
|---|---|---|
| control period | Sham comparator | control period with no intervention. Comparison of parameters at entrance and one month later without any intervention Receives: Behavioral: Control period |
| Diet group | Experimental | Mediterranean diet prescription during 3 months Receives: Behavioral: Diet Group |
| Exercise group | Experimental | Subjects will be trained 3 times a week during 3 months Receives: Behavioral: Exercise group |
| Diet + Exercise | Experimental | Both a dietary prescription plus exercise training during 3 months Receives: Behavioral: Diet + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mitochondrial density in muscle tissue
As described in the methodology section
Measured: 3 months
Secondary outcomes (1)
Change in Oxidative damage in muscle tissue
As described in the methodology section
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Serious difficulties for patient recruitment to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After a placebo phase with no intervention in the first 25 subjects recruited, overweight or obese patients were randomly assigned to one of 3 treatments: hypocaloric diet, high intensity interval training or both interventions simultaneously, for 3 months.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Principal investigator, MARIA PIA DE LA MAZA, University of Chile
- Investigators
- Maria Pia de la Maza, Professor, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793896
- Sponsor's protocol ID
- Fondecyt 1130284
- Other IDs
- INSTITUTE OF NUTRITION 2013
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Biogenesis, Reduction of Muscle Oxidative Damage and Improvement in Adipose Tissue Functional Profile, Account for the Beneficial Effects of Exercise and Healthy Diets
- ClinicalTrials.gov ID
- NCT01793896
- Acronym / sponsor ID
- Fondecyt 1130284
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, Ageing, Mitochondrial density, Oxidative damage, Inflammatory mediators, AMPK, Adipogenesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Serious difficulties for patient recruitment to recruit patients
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- Jul 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both dietary caloric restriction (CR) and physical exercise (PE) exert beneficial effects, which retard or prevent age-related diseases and prolong life span. Subjects with the metabolic syndrome age prematurely, therefore preventive measures should be initiated early. The present study intends to demonstrate that physical exercise and/or Mediterranean diet, in middle aged volunteers with the metabolic syndrome, preserve adequate adipose tissue functionality and retard skeletal muscle aging (assessed by mitochondrial biogenesis and accumulation of ROS), by activating several pathways, homologous to CR. The investigators plan to study this by using two approaches: 1) A cross- sectional model, in which the expression of the mentioned metabolic mediators, indicators of muscle mitochondrial biogenesis and muscle oxidative damage will be compared between men with different body compositions, fat distribution, muscle strength and exercise capacity (VO2max). Also, in these men the investigators will assess the expression of uncoupling protein 1 (UCP1) in subcutaneous white adipose tissue (as a measure of adaptive thermogenesis), and inflammatory markers (Interleukin 1-6, Interleukin 1ß and CCL2 chemokine (C-C motif ligand 2)) in preperitoneal adipose tissue, plus inflammation and adipogenesis potential of their cultured preadipocytes. Moreover, in vitro studies will evaluate the functional effects of exposure of a cell lyne of human adipocyte cells (LS14)to factors secreted by media conditioned by the patients´ adipose tissue explants. 2) A prospective intervention in overweight/moderately obese middle aged volunteers that will be assigned to a weight-maintenance period (as a control group), and then randomly y assigned to a Mediterranean diet, exercise training or diet plus training. Before and after 3 months of intervention the investigators will obtain muscle tissue samples to study the expression of Peroxisome proliferator activated receptor (PPAR) gamma coactivator 1 alpha (PGC1), uncoupling protein 3 (UCP3), AMP activated protein kinase (AMPK), Sirtuin 1 (SIRT-1), mitochondrial DNA and oxidative damage indicators (8-oxo-7,8-dihydro-2-deoxyguanosine (oxodG), carboxymethyllysine (CML and its receptor (RAGE)). In vitro studies will evaluate the effect of circulating factors from the patients (serum) on LS14 inflammatory and adipogenic potential, at baseline and after 3 months of intervention.
Detailed description
METHODOLOGY:
This study will be composed of 2 parts:
I - CROSS SECTIONAL STUDY The aim of this section is to compare men with different body compositions, fat distribution and exercise capacity with respect to their muscle mitochondrial biogenesis, oxidative damage and energy flux regulator molecules, together with their adipose tissue inflammation, adipokine expression and thermogenic potential.
Inclusion criteria :
- male sex
- age 25 - 50 years
- BMI from 20 - 35 kg/mt2
- indication for surgery of an inguinal hernia
Exclusion criteria:
- diabetes mellitus
- chronic neuromuscular or neurological deficits precluding normal physical activity
- heavy smoking (> 5 cigarettes per day)
- alcohol intake > 30 g/day
- chronic diseases such as cancer, HIV-AIDS, renal, pulmonary, cardiac or hepatic conditions.
Before the operation and after signing a written informed consent, the following assessment will be performed:
- Medical history including medication intake and complete physical examination.
- Dietary recall of habitual intake and calculation of AGEs ingestion.
- Regular physical activity assessment using the International Physical Activity Questionnaire
- Anthropometrics (height, weight, waist circumference)
- Fasting blood sampling for routine determinations (haemoglobin,lipoproteins, creatinine,prothrombin, TSH), AGEs concentrations (CML) free fatty acids, adiponectin and 8- Isoprostanes.
- Fasting and post glucose serum sampling for glucose and insulin measurements, and calculation of Homeostasis Model Assessment (HOMA-IR) and the Matsuda Index for determination of peripheral insulin sensitivity.
- Resting and exercise indirect calorimetry for estimation of resting energy expenditure, respiratory quotient and VO2 max.
- Handgrip and quadriceps muscle strength
- Dual X-Ray Energy Densitometry (DEXA) for estimation of body composition
- CT scan of abdominal region at L4 level for measurement of visceral and subcutaneous fat areas and estimation of liver fat infiltration.
- Ultrasound intensity analysis in thigh ultrasonography indicating muscle fat infiltration. After the initial evaluation, subjects will be classified as with or without the metabolic syndrome, according to the international guidelines guidelines, for further analysis of data.
A few days later, during the surgical procedure, a sample of muscle tissue (approximately 200 mg of internal abdominal oblique) will be obtained for measurement of:
- Fiber type
- Messenger Ribonucleic acid (mRNA) expression of PGC-1-alpha, SIRT-1, UCP-3 and AMPK
- Mitochondrial density by measurement of mitDNA and Cytochrome C activity
- Oxidative damage (8-oxodG, CML and RAGE).
During the same operation, 2 samples of adipose tissue will also be obtained, one subcutaneous (at the site of the incision) and the other preperitoneal (at the inguinal sac), for in vitro studies:
- UCP1 and inflammatory marker (interleukin 6, 1ß, CCL2) expression in mature adipocytes
- Inflammatory profile and adipogenic potential (expression of lipoprotein lipase, PPAR gamma and adiponectin) in cultured preadipocytes
- Adipogenic potential and inflammatory expression profile of LS14 adipose cells exposed to conditioned media from adipose tissue explants.
A small part of these adipose tissue samples will be placed in formaldehyde, fixed and stained with H.E for histologic estimation of adipocyte cell size.
II - INTERVENTION STUDY This section intends to demonstrate the effects of a low-AGEs Mediterranean diet and/or exercise, over skeletal muscle metabolic profile and adipogenic/inflammatory features of adipocytes.
Inclusion criteria:
- Overweight or obese men and women
- Ages 25 - 50 years
- Interest in losing weight
Exclusion criteria:
- weight fluctuations (> 3 k in the last 3 months)
- diabetes mellitus
- chronic neuromuscular or neurologic diseases
- heavy smoking (> 5 cigarettes per day)
- alcohol intake > 30 g/day
- chronic diseases such as cancer, HIV, renal, pulmonary, cardiac or hepatic conditions.
Subjects will be invited to participate in a trial using a Mediterranean low-AGEs diet and/or physical exercise during 3 months. After signing a written informed consent,subjects will be allocated to one of these interventions, which will be randomly selected, and the following assessment will be performed, at baseline and after 3 months of intervention:
- Medical and medication intake history and complete physical examination.
- Dietary recall of habitual intake and calculation of AGEs ingestion.
- Physical activity questionnaire (IPAQ)
- Anthropometrics (height, weight, waist circumference)
- Fasting blood sampling for routine determinations (haemoglobin, lipoproteins, creatinine, prothrombin and TSH), AGEs concentrations (CML), free fatty acids, adiponectin, 8-Isoprostanes and serum for in vitro adipose tissue studies (see below).
- Fasting and post glucose blood sampling for glucose and insulin measurements, and calculation of HOMA-IR and the Matsuda Index for determination of peripheral insulin sensitivity.
- Dual X-Ray Energy Densitometry (DEXA) for estimation of body composition
- CT scan of abdominal region at L4 level for measurement of visceral and subcutaneous fat areas and estimation of liver fat infiltration
- Resting and exercise indirect calorimetry for estimation of resting energy expenditure, respiratory quotient and VO2 max.
- Handgrip and quadriceps muscle strength
- Ultrasound intensity analysis in thigh indicating muscle fat infiltration
- Ultrasound guided quadriceps muscle biopsy to measure mitochondrial density (mitDNA) and expression of PGC-1
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- After a placebo phase with no intervention in the first 25 subjects recruited, overweight or obese patients were randomly assigned to one of 3 treatments: hypocaloric diet, high intensity interval training or both interventions simultaneously, for 3 months.
| Arm | Type | Receives |
|---|---|---|
| control period | Sham comparator | Behavioral: Control periodcontrol period with no intervention. Comparison of parameters at entrance and one month later without any intervention |
| Diet group | Experimental | Behavioral: Diet GroupMediterranean diet prescription during 3 months |
| Exercise group | Experimental | Behavioral: Exercise groupSubjects will be trained 3 times a week during 3 months |
| Diet + Exercise | Experimental | Behavioral: Diet + ExerciseBoth a dietary prescription plus exercise training during 3 months |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CROSS SECTIONAL: male sex, age 25 -50 years, with BMI ranging from 20 to 35 kg/mt2. INTERVENTION STUDY: Overweight or obese men and women aged 25 - 50 years interested in losing weight,will
Key exclusion criteria (3 listed)
- CROSS SECTIONAL : diabetes mellitus, chronic neuromuscular or neurological deficits precluding normal physical activity, heavy smoking (> 5 cigarettes per day), alcohol intake > 30 g/day and chronic diseases such as cancer, HIV-AIDS, renal, pulmonary, cardiac or hepatic conditions.
- INTERVENTION STUDY: weight fluctuations (> 3 k in the last 3 months), diabetes mellitus, chronic neuromuscular or neurologic diseases, heavy smoking (> 5 cigarettes per day) and alcohol intake > 30 g/day, and chronic diseases such as cancer, HIV, renal, pulmonary, cardiac or hepatic conditions.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control periodAlso: Before randomizationAnalysis at recruitment and after a month without any intervention | Behavioural | control period |
| Diet GroupAlso: Mediterranean dietselected subjects will adopt a Mediterranean low-AGE diet. We will not include red wine in the Mediterranean diet (7 Kilocalories (KCal)/g), in order to attain more weight loss. Each subject will be instructed to reduce 500 Kcal of their estimated total daily energy requirements, so theoretically they will be able to reduce 5 - 10 % of their body weight in 3 months. | Behavioural | Diet group |
| Exercise groupThe intervention will consist of 3 weekly 1 hour sessions (5 minutes of preconditioning, followed by 20 minutes cycling, brisk walking or jogging at 65-70 % maximal aerobic capacity, then 25 minutes resistance weight-lifting exercises and finally 10 minutes of stretching). Exercise intensity will be increased weekly according to the Borg Scale intensity. The exercise intervention will be supervised by physical education teachers, registering attendance at every session. | Behavioural | Exercise group |
| Diet + Exercisethese patients will be incorporated to receive both Mediterranean diet plus exercise interventions | Behavioural | Diet + Exercise |
Primary outcome
Change in mitochondrial density in muscle tissue
Time frame: 3 months
As described in the methodology section
1 secondary outcome
Change in Oxidative damage in muscle tissue
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Serious difficulties for patient recruitment to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Pia de la Maza, Professor principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Group, Exercise group and Diet + Exercise in people with Metabolic Syndrome, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Serious difficulties for patient recruitment to recruit patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mitochondrial density in muscle tissue (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.