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:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT02520258
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged 18 - 45
2. Weight stable for at least 3 months prior to screening (\< 5% weight change)
3. BMI of 21 - 29
4. Cohort 1 - Aspartame Consumers: Primary dietary sweetener is aspartame; consumes at least 36 ounces of diet soda in which aspartame is a primary ingredient (Diet Coke or Diet Dr Pepper) a day for at least 6 months duration prior to study enrollment (Primary dietary sweetener is aspartame" should be defined as: "840g per week sucrose equivalent from aspartame and less than 280 grams per week sucrose equivalent from all other sweeteners (non-caloric and caloric sweeteners). For reference, one 12oz soda is 40g sucrose equivalent, and one teaspoon (one packet) of artificial sweetener is 4g sucrose equivalent.)"
Cohort 2 - Aspartame Naïve Participants: Consumes less than or equal to 2 cans of diet soda per week
5. Screening Visit #2 OGTT Outcome:
* 0-h plasma glucose \< 110 mg/dl AND
* 2-h plasma glucose \< 140 mg/dl
6. Abnormal OGTT during the screening phase of the study (area under curve on the high end of distribution)
7. Must be able to comply with a metabolic Prudent diet
8. Willing to fast 10 hours before each OGTT and BodPod
9. Current level of exercise (aerobic and/or resistance training) must be able to be sustained while an in-patient
Exclusion Criteria:
1. Any evidence of US National Cholesterol Education Program Adult Treatment Panel III
Clinical Identification of the Metabolic Syndrome (must have 3 or more of the following risk factors):
Abdominal Obesity, given as a waist circumference:
* Men \>102 cm (\>40 in)
* Women \> 88 cm (\>35 in)
Triglycerides \>150 mg/dl
HDL Cholesterol:
* Men \< 40 mg/dl
* Women \<50 mg/dl
Blood Pressure \>130/ \>85 mm Hg
Fasting Glucose \> 110 mg/dl
2. Average systolic blood pressure (SBP) \> 150 mmHg and / or diastolic blood pressure (DBP) \> 90 mmHG (based on 3 BPs taken at screening visit #1),
3. LDL-C \> 240mg/dl
4. Triglycerides \> 400 mg/dl
5. Evidence of a liver disorder (ALT \> three fold of the ULN)
6. Evidence of any renal disease
7. Currently on a weight-loss diet
8. Diabetes
9. Self-reported history of thyroid dysfunction
10. Sugar sweetened beverage consumption (\> 84 ounces per week)
11. Hemoglobin \<13.0 g/dl for males and 12.0 g/dl for females
12. Current, prior (within 2 months), or anticipated use of any of the following medications:
antihyperlipidemic, hyperglycemic medications, Antineoplastics, Antiretrovirals, Selective Serotonin Reuptake Inhibitors, Diuretics, Antihypertensives, Anticonvulsants, Hormone therapy, Birth control
13. Self-reported antibiotic use within the previous 3 months
14. Currently pregnant or lactating
15. History of cardiac disease
16. Active illegal drug user (self-reported)
17. History of GI surgery (gastric bypass, bariatric, Roux-en-Y, colon resection, etc.)
18. Habitual ingestion of \> 2 alcoholic beverages/day
19. Ever diagnosed with an eating disorder (self-reported)
20. Use of steroids or beta agonists (orally, intranasal or inhaled) within a week of any OGTT
21. Positive Hepatitis Serology (Hep. B surface Antibody; Hep. B surface antigen; Hep. C surface antibody)
22. HIV Positive
23. Tobacco use within the past 3 months
24. Any medical or social condition that, in the opinion of the Investigator, might pose additional risk to the participant or confound the results of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02520258
Study Brief:
Protocol Section:
NCT02520258