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 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
NCT ID:
NCT05103761
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 to 65 years
* Normolipidemic
* Plasma TG \<2.0 mmol/L (\~175 mg/dL)
* HDL \>1.0 mmol/L (\~40 mg/dL) ) in men or \>1.3 mmol/L (50 mg/dL) in women
* LDLc \<4.0 mmol/L (\~150 mg/dL)
* Total cholesterol \<5.0 mmol/L (\~200 mg/dL)
* Blood pressure ≤ 140/90 mmHg
* Fasting plasma glucose ≤ 6.3 mmol/L (125 mg/dL)
* HbA1c within ≥ 4.0% to ≤ 6.0%
* Hb \> 130
* BMI between 18-30 kg/m2
* Participant agrees to maintain their usual lifestyle and not make any significant changes to activity levels while enrolled in the study
* Cr \< 110 umol
* Able to speak and read English
* Agrees to consume each study diet for eight weeks
* Agrees to refrain from alcohol consumption 12 hours before the study
Exclusion Criteria:
* Patients on active treatment using lipid-lowering medications, such as statins, ezetimibe, or bile acid sequestrants
* Use of medications that interfere with protein, carbohydrate, or lipid metabolism (e.g., fish oil capsules)
* Patients who have unstable weight in the past three months (weight loss)
* Patients with a history of gout
* Patients who have had major surgeries
* Abnormal thyroid function or known liver disease
* Patients with chronic kidney disease, decompensated liver disease, unstable cardiac or respiratory disease, or GFR
* Uncontrolled hypertension
* Patients who are pregnant or breastfeeding or peri-menopausal
* Actively attempting to get pregnant or pregnant. Low dose estrogen-containing pill if taken for \> 3 months and continued throughout the study is acceptable. Women will be required to use adequate contraception and a pregnancy test will be performed on all women at the time of screening and immediately before each kinetics study.
* Participant has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose additional risk to the participant by their participation in the study.
* Abnormal bleeding, frequent headaches, arthritis, stomach problems, SOB, migraines, black outs/fainting, epilepsy, chest pain, asthma
* Participants who consume vegan diet
* Participant consumes excessive amounts of alcohol, defined as \>70 g/wk (5 standard drink/wk) for female, and \>140 g/wk (10 standard drink/wk) for male.
* One standard drink contains roughly 14 grams of pure alcohol, which is found in: 12 ounces of regular beer, 5 ounces of wine or 1.5 ounces of distilled spirits. Vigorous-intensity physical activity, defined as more than 150 minutes per week of moderate-intensity, or 75 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of both.
* Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy visit.
* Participants have an upcoming special event during the study (wedding, vacation travel, etc.).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05103761
Study Brief:
Protocol Section:
NCT05103761