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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04195594
Eligibility Criteria:
Inclusion Criteria:
1. Provided voluntary, written, informed consent to participate in study
2. Males and females between 30 and 55 years of age
3. BMI between 20.0 to 29.9 kg/m2, inclusive
4. Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or,
Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:
* Non hormonal contraceptives
* Double-barrier method
* Intrauterine devices
* Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
* Vasectomy of partner at least 6 months prior to screening
5. Subjects with mid-range (2.5-4.1mmol/L or 100-159 mg/dL) elevated LDL-C levels
6. Agrees to maintain current level of physical activity throughout the study
7. Willingness to complete all questionnaires, records, and diaries and assessments associated with the study and to complete all clinic visits.
8. Healthy as determined by medical history, laboratory results, and as assessed by Qualified Investigator (QI)
Exclusion Criteria:
1. Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
2. Women who are menopausal or post-menopausal
3. Currently following a diet (i.e. Ketogenic Diet, low-carbohydrate diet)
4. Subjects with high TSH level (\>4.5mU/L) or Self reported pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
5. Participants with type I or II Diabetes Mellitus
6. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
7. Participants with previous or current pathology of the pancreas
8. Current or history of Gastroesophageal reflux disease (GERD) or any significant disease of the gastrointestinal tract
9. Self reported hypertension or on hypertensives.
10. Significant cardiovascular event in the past 6 months as assessed by the QI.
11. Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
12. Gastric bypass surgery
13. Individuals with an autoimmune disease or are immune-compromised
14. Self reported HIV-, Hepatitis B- and/or C-positive diagnosis
15. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months
16. Self reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
17. Self reported blood/bleeding disorders as per QI
18. Current use of prescribed medications listed in Section 7.3.1
19. Current use of over-the-counter medications, supplements, foods, and/or drinks listed in Section 7.3.2
20. Alcohol or drug abuse within the last 12 months
21. High alcohol intake (\>2 standard drinks per day or \>10 standard drinks per week)
22. Clinically significant abnormal laboratory results at screening as assessed by the QI
23. Metal implants that may affect the DEXA scan results will be assessed on case-by-case basis by the QI
24. Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
25. Participation in a clinical research trial within 30 days of study initiation
26. Individuals who are unable to give informed consent
27. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or may pose significant risk to the participant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT04195594
Study Brief:
Protocol Section:
NCT04195594