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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT00858312
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) 28 -3 4.9 kg/m2
* Age 20-45 years for females, age 20-50 for males
* Low calcium diet (determined by food frequency and diet history): \< 1 serving of dairy foods and total dietary Ca intake from all sources not to exceed 600 mg/d .
* No more than 3 kg weight loss during past three months
* Negative pregnancy test at entry prior to DXA and abdominal CT scan; pregnancy testing will be repeated done at 6 weeks of diet intervention to insure that women do not become pregnant during the energy restriction period. Should a woman become pregnant she will be dismissed from the protocol. Pregnancy testing will also be done at the end of the study prior to DXA and abdominal CT scans
Exclusion Criteria:
* BMI\<28or\>37. BMI greater than 37 indicates another level of obesity and the potential for numerous obesity related endocrine changes and substrate utilization abnormalities.
* Type II diabetes requiring the use of any oral anti-diabetic agent and/or insulin (because of confounding effects on body weight regulation).
* Fasting glucose \> 110 mg/dl.
* Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy; this will be determined by self-report.
* High calcium diet (determined by food frequency and diet history): Greater than 600 mg calcium per day from all sources (Ca supplements, dairy foods and other dietary sources).
* History or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease).
* Use of hypertension or lipid altering medications.
* Resting blood pressure \> 160/100 mg/Hg
* Total cholesterol \> 300mg/dl or triglyceride value \> 400 mg/dl or LDL \> 160 mg/dl.
* History of eating disorder
* Presence of active gastrointestinal disorders such as malabsorption syndromes
* Pregnancy or lactation
* Use of obesity pharmacotherapeutic agents within the last 12 weeks
* Use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanolamine, ephedrine and/or caffeine) within the last 12 weeks
* Use of calcium supplements in the past 12 weeks
* Recent (past four weeks) initiation of an exercise program
* Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
* Use of tobacco products.
* Exercise more than 30 minutes/day - greater than this may influence substrate utilization.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT00858312
Study Brief:
Protocol Section:
NCT00858312