Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01116856
Eligibility Criteria:
For Overweight phase:
Inclusion Criteria:
* Volunteers: men and women from Comunidad de Madrid (Zone 5 of Health System) who sign the informed consent.
* Ages 18 - 50 years old.
* Pre-menopausal.
* Body mass index (BMI) of 25 - 30 kg•m-2 (both included).
* Able to attend exercise classes 3 times per week (Monday, Wednesday and Friday). No plans for excessive travel. No plans to move from area for study period (January 2010 - June 2010, both included).
* Able to follow the nutritional treatment (avoid medication or substances known to interfere with body weight regulation, including anti-depressive medication, diuretics, etc., 15 days before study starts).
* Willing to not participate in other formal or informal weight loss program during the period of the study.
* Sedentary (less than once a week of training or two hours of physical activity class).
Exclusion Criteria:
* Smoking within six months, or use of tobacco or nicotine product.
* Women with irregular menstrual cycle (except with hormone therapy).
* Following a weight loss diet, vegetarians or food restriction due to religion.
* Self-reported weight loss or gain \>5% in past 6 months.
* Are not pregnant, or haven´t been in the past six months. Are not currently nursing or planning to become pregnant during the study period (year 2010).
* Need a special diet by associated disease (celiac disease or chronic renal insufficiency).
* Have metabolic syndrome or fulfill three or more of the following criteria: abdominal obesity (waist diameter \> 102 cm in men and \> 88 cm in women), blood pressure ≥ 130/85 mm Hg, basal glycemia ≥ 110 mg/dL, triglyceride level \> 150 mg/dL and C-HDL \< 40 mg/dL in women and \< 50 mg/dL in men.
* Diabetes.
* Anemia (Hct \< 37%).
* Uncontrolled high blood pressure (Systolic \> 160 mm Hg or diastolic \> 100 mm Hg in rest). Current use of more than one anti-hypertensive medication.
* Substance abuse (drugs, alcohol…). High or moderate consumes of alcohol. More than 2 glasses to the day of any alcoholic substance. Current use of diuretics, beta blockers, steroids or blood thinners.
* Contraindication to exercise. Alterations, syndromes or diseases detected by electrocardiogram (EKG) o echocardiography. Have injuries o pathologies of the locomotive apparatus that prevent the correct execution of the exercises of the program. Any illness that would prevent participation in a moderate-intense exercise program.
* Have had cancer in the past 5 years, except skin cancer.
* Coronary artery disease, liver disease, pulmonary disease, renal disease or other systemic disorders.
* History or evidence of cardiovascular disease, alterations, syndromes or other mayor chronic illness. Have history of heart disease, heart attacks or heart surgery.
* Have any illness known to interfere with body weight loss: clinical depression, eating disorder (anorexia, bulimia, etc.), psychological diseases (schizophrenia, etc.), dementia or cognitive function decreased, hypothyroidism no controlled or history of genetic or chromosomal disorder.
* Have had bariatric surgery or stomach bypass surgery.
* Gross physical impairment.
* Blindness or retinopathy.
For Obese phase:
Inclusion Criteria:
* Volunteers: men and women from Comunidad de Madrid (Zone 5 of Health System) who sign the informed consent.
* Ages 18 - 50 years old.
* Pre-menopausal.
* Body mass index (BMI) of 30 - 35 kg•m-2 (both included).
* Able to attend exercise classes 3 times per week (Monday, Wednesday and Friday). No plans for excessive travel. No plans to move from area for study period (January 2011 - June 2011, both included).
* Able to follow the nutritional treatment (avoid medication or substances known to interfere with body weight regulation, including anti-depressive medication, diuretics, etc., 15 days before study starts).
* Willing to not participate in other formal or informal weight loss program during the period of the study.
* Sedentary (less than once a week of training or two hours of physical activity class).
Exclusion Criteria:
* Smoking within six months, or use of tobacco or nicotine product.
* Women with irregular menstrual cycle (except with hormone therapy).
* Following a weight loss diet, vegetarians or food restriction due to religion.
* Self-reported weight loss or gain \>5% in past 6 months.
* Are not pregnant, or haven´t been in the past six months. Are not currently nursing or planning to become pregnant during the study period (year 2011).
* Need a special diet by associated disease (celiac disease or chronic renal insufficiency).
* Have metabolic syndrome or fulfill three or more of the following criteria: abdominal obesity (waist diameter \> 102 cm in men and \> 88 cm in women), blood pressure ≥ 130/85 mm Hg, basal glycemia ≥ 110 mg/dL, triglyceride level \> 150 mg/dL and C-HDL \< 40 mg/dL in women and \< 50 mg/dL in men.
* Diabetes.
* Anemia (Hct \< 37%).
* Uncontrolled high blood pressure (Systolic \> 160 mm Hg or diastolic \> 100 mm Hg in rest). Current use of more than one anti-hypertensive medication.
* Substance abuse (drugs, alcohol…). High or moderate consumes of alcohol. More than 2 glasses to the day of any alcoholic substance. Current use of diuretics, beta blockers, steroids or blood thinners.
* Contraindication to exercise. Alterations, syndromes or diseases detected by electrocardiogram (EKG) o echocardiography. Have injuries o pathologies of the locomotive apparatus that prevent the correct execution of the exercises of the program. Any illness that would prevent participation in a moderate-intense exercise program.
* Have had cancer in the past 5 years, except skin cancer.
* Coronary artery disease, liver disease, pulmonary disease, renal disease or other systemic disorders.
* History or evidence of cardiovascular disease, alterations, syndromes or other mayor chronic illness. Have history of heart disease, heart attacks or heart surgery.
* Have any illness known to interfere with body weight loss: clinical depression, eating disorder (anorexia, bulimia, etc.), psychological diseases (schizophrenia, etc.), dementia or cognitive function decreased, hypothyroidism no controlled or history of genetic or chromosomal disorder.
* Have had bariatric surgery or stomach bypass surgery.
* Gross physical impairment.
* Blindness or retinopathy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01116856
Study Brief:
Protocol Section:
NCT01116856