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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT02743195
Eligibility Criteria:
Inclusion Criteria:
1. Males and Females 20-60 years of age
2. Female subjects of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier methods
Non-hormonal intrauterine devices
Vasectomy of partner
Non-heterosexual lifestyles
3. Subjects with BMI of 29.9-39.9±1 kg/m²
4. Subjects who agree to maintain their current level of physical activity throughout the trial period
5. Subjects who agree to discontinue the use or pre- and probiotic and/or polyphenol supplements from four weeks prior to baseline and for the duration of the study
6. Subjects who agree to discontinue foods containing anthocyanins (such as blueberries, blackberries, cherries, grapes, grape juice, pomegranate, raspberries, huckleberries, strawberries, and wine) from two weeks prior to baseline and for the duration of the study
7. Healthy as determined by laboratory results and medical history
8. Subjects must agree to comply with study procedures
9. Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
2. Subjects who have used an over-the-counter or prescription laxative medication within 4 weeks prior to baseline
3. Subjects who have used prebiotic, probiotic supplements or supplemented foods within 4 weeks of enrollment
4. Use of polyphenol supplements within 4 weeks prior to baseline
5. Subjects with type I diabetes or uncontrolled type II diabetes
6. Previous history of gastrointestinal surgery (except appendectomy, hernia repair, or hemorrhoidectomy).
7. Previous history of gastrointestinal diseases (except hemorrhoids and uncomplicated diverticula), as assessed by ultrasonography, colonoscopy, or rectoscopy, or history of Clostridium difficile-associated diarrhea
8. Presence of rectal bleeding (unless due to hemorrhoids)
9. Recent weight-loss (greater than 5 kg in the past month)
10. Iron deficiency (anemia) diagnosed within 3 months of baseline
11. Subjects who were smokers within 1 year of baseline
12. Subjects with active eating disorder
13. Subjects who have used oral antibiotics within 5 weeks of baseline
14. Unstable medical condition as determined by principal investigator
15. History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years of diagnosis are acceptable.
16. Alcohol abuse or drug abuse within the past 6 months
17. Consumption of \>2 standard alcoholic drinks per day
18. Use of medicinal marijuana
19. Use of anti-inflammatory medications, more than once per week or if prescribed by a physician, 4 weeks prior to randomization and for the duration of the study
20. Participation in a clinical research trial within 30 days prior to baseline
21. Allergy or sensitivity to the test material's active or inactive ingredients
22. Allergy or sensitivity to Lactulose or Mannitol
23. Individuals who are cognitively impaired and/or who are unable to give informed consent
24. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT02743195
Study Brief:
Protocol Section:
NCT02743195