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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05191160
Eligibility Criteria:
Inclusion Criteria:
* Adults (age 18-75 years), men and non-pregnant women
* Overweight or obese (≥ 25 kg/m2)
* High waist circumference (USA/Canada ≥102cm in men, ≥88cm in women; Europid/Caucasian/Middle East, Mediterranean/Sub-Saharan African ≥94cm in men, ≥80cm in women; and Asian \[including Japanese\]/Ethnic Central and South American ≥90cm in men, ≥80cm in women\[37\], with a waist diameter ≤60 cm)
* Regularly drinking SSBs (≥ 1 servings/day))
Exclusion Criteria:
* Age \<18 or \>75 years.
* BMI \<25.
* Waist circumference lower than threshold\[37\] (USA/Canada \<102cm in men, \<88cm in women; Europid/Caucasian/Middle East, Mediterranean/Sub-Saharan African \<94cm in men, \<80cm in women; and Asian \[including Japanese\]/Ethnic Central and South American \<90cm in men, \<80cm in women) or a waist diameter \>60cm.
* Uncontrolled hypertension (or systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg
* Self-reported diabetes
* Not regularly drinking SSBs (\<1 serving per day)
* Self-reported cow's milk or soy intolerance or allergy
* Self-reported pregnant or breast-feeding females, or women planning on becoming pregnant throughout the study period
* Self-reported weight loss of ≥10% in the last 6 months
* Complementary or alternative medicine (CAM) use as deemed inappropriate by investigators
* Self-reported Wilson's disease
* Self-reported haemochromatosis
* Self-reported inborn errors of metabolism
* Self-reported lipodystrophy
* Self-reported Cushing syndrome or disease
* Self-reported gastrointestinal disease (inflammatory bowel disease or malabsorption disorder)
* Previous bariatric surgery
* Self-reported alcoholic fatty liver disease, cirrhosis, hepatocellular carcinoma, HCV, HBV, or HAV infection, or genetic causes of liver disease (Alpha-1-antitrypsin \[A1A\] deficiency)
* Self-reported uncontrolled hyperthyroidism or hypothyroidism
* Self-reported high risk or very high risk chronic kidney disease (CKD) (KIDIGO 2012 criteria)
* Self-reported acute or chronic infection (e.g. salmonellosis, HIV, TB)
* Self-reported chronic inflammatory conditions
* Self-reported chronic lung disease
* Self-reported chronic pancreatitis or pancreatic insufficiency
* Self-reported cystic fibrosis
* Self-reported cancer/malignancy in the last 6 months, with the exception of skin cancer
* Self-reported schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, and dissociative disorders
* Self-reported severe depression
* Self-reported major surgery in the last 6 months
* Self-reported hypopituitarism
* Self-reported hypogonadism
* Self-reported substance abuse disorder (substance dependence including alcohol or recreational drugs)
* Participation in any trials within the last 3 months or for the duration of this study
* Any condition or circumstance which would prevent you from having an MRI (e.g. pacemaker, neurostimulators, breast tissue expanders, implants, or foreign metal object in body)
* Individuals planning on making dietary or physical activity changes throughout study duration
* If self-reported medication use, it must be at a stable dose for ≥6 months.
\*\*Disease exclusions will be based upon self-reported diagnosis\*\*
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05191160
Study Brief:
Protocol Section:
NCT05191160