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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT01642368
Eligibility Criteria:
Inclusion Criteria:
* 18-40 years of age
* Healthy and able to perform all requirements of the study without injury.
* Body Mass Index (BMI), \>18 and \<30 Kg/m2 (BMI is a measure of your height and weight ratio.
* No history of cardiac problems or evidence of current heart problems.
* willing to use effective method of birth control if you are capable of bearing children.
* willing to consume menus for 10 consecutive weeks.
* willing to complete all study-related activities.
* If you are taking dietary supplements, you are willing to discontinue their use during the study.
* willing to follow the alcohol consumption restrictions during the study.
* Have access to a personal microwave and refrigerator to keep foods at the proper temperature for storage and consumption.
Exclusion Criteria:
* Have a history of gall stones or any other significant metabolic, blood, lung, neurologic (nervous system), immune, liver, kidney, or urologic (urinary system) disorders.
* Have any disease or condition that seriously affects body weight and/or body composition.
* Practice a vegan or vegetarian dietary lifestyle.
* Are gluten intolerant (allergic reaction to wheat products)
* Have a history of short-term (less than a month) treatment woth steroids within six months prior to randomization into the 003 Diet Study.
* Require regular use of medications that ma interfere with the study (other than contraceptives or other medications that have been on a stable dose for 6 months prior to the study). the study staff will review all medication criteria with you.
* Have diabetes.
* Have a history or evidence of significant gastrointestinal dysfunction.
* Chronically use laxatives, The use of stool softeners is acceptable. Use of bulking agents, if required, should remain constant.
* Have abnormal blood or urine results.
* Have evidence or recurrence of cancers within the past five years if it is thought to interfere with study participation, other than some skin cancers.
* Anticipate surgery during the study period.
* Donated blood during the month prior to study entry or plan to during the study.
* Have participated in other studies using an investigational drug during the preceding 3 months.
* Have had a fluctuation in body weight \>10% (or about 15 lbs) in the preceding 2 months.
* Are taking prescription or over the counter medication or supplements for desired weight loss.
* Are taking prescription or over the counter medication or supplements for desired weight loss.
* Drink more than 4 alcoholic drinks daily or 6 on one occasion more than once a month within the past 6 months.
* Currently using cocaine, amphetamines, or other illicit substances.
* Have a psychiatric disorder that would interfere with your ability to complete the study.
* Are claustrophobic.
* Have a history of post-traumatic stress disorder, anxiety or panic attack disorders, or other psychological/fear/or anxiety disorders.
* Are unwilling or unable to follow the rigors of the data collection and clinical evaluation schedule over the study period.
* Are pregnant, breast feeding or planning to become pregnant before the end of the study.
* Are unwilling to be assigned at random to any intervention group.
* Are participating in another intervention program.
* Consume seafood more than 3 times per week in a the last 6 months (specifically tuna, salmon, and other types of fatty cold fishes or seafood).
* Use NSAIDS (asprin, ibuprofen, etc.) more than 2 times per week.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01642368
Study Brief:
Protocol Section:
NCT01642368