Strategies To OPpose Sugars With Non-nutritive Sweeteners Or Water (STOP Sugars NOW) Trial
Healthy, Overweight and Obesity, Metabolic Syndrome
About this trial
This is an interventional prevention trial for Healthy focused on measuring Microbiome, Sugar Sweetened Beverages, Diet Beverages, Non-Nutritive Sweetened Beverages, Glucose response
Eligibility Criteria
Inclusion Criteria:
- Healthy, adult (age, 18-75 years) men and non-pregnant women;
- Overweight or obese (BMI > 23 kg/m2 for Asian individuals and > 25 kg/m2 other individuals);
- High waist circumference (> 94 cm in men, > 80 cm in women in Europid, Sub-Saharan African, Eastern Mediterranean, and Middle Eastern individuals; > 90 cm in men and > 80 cm in women for South Asian, Chinese, Japanese, and South and Central American individuals);
- Currently report drinking SSBs regularly (≥ 1 serving daily);
- Have a primary care physician;
- Nonsmoker;
- Free of any diseases or illnesses;
- Not regularly taking any medications that have a clinically relevant effect on the primary outcomes, as deemed inappropriate by investigators
Exclusion Criteria:
- Age < 18 or > 75 years;
- BMI < 23 kg/m2 for Asian individuals and < 25 kg/m2 other individuals;
- Waist circumference < 94cm in men, < 80cm in women in Europid, Sub-Saharan African, Eastern Mediterranean, and Middle Eastern individuals; < 90cm in men and < 80 cm in women for South Asian, Chinese, Japanese, and South and Central American individuals;
- Not regularly drinking SSBs (≥1 serving per day);
- Pregnant or breast feeding females, or women planning on becoming pregnant throughout study duration;
- Regular medication use that have a clinically relevant effect on the primary outcomes, as deemed inappropriate by investigators
- Antibiotic use in the last 3 months;
- Complementary or alternative medicine (CAM) use as deemed inappropriate by investigators;
- Self-reported diabetes;
- Self-reported uncontrolled hypertension (or systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg [26]);
- Self-reported polycystic ovarian syndrome;
- Self-reported cardiovascular disease;
- Self-reported gastrointestinal disease;
- Previous bariatric surgery;
- Self-reported liver disease;
- Self-reported uncontrolled hyperthyroidism or hypothyroidism;
- Self-reported kidney disease;
- Self-reported chronic infection;
- Self-reported lung disease;
- Self-reported cancer/malignancy;
- Self-reported schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, and dissociative disorders;
- Major surgery in the last 6 months;
- Other major illness or health-related incidence within the last 6 months;
- Smoker;
- Regular recreational drug users;
- Heavy alcohol use (> 3 drinks/day);
- Do not have a primary care physician;
- Participation in any trials within the last 6 months or for the duration of this study;
- Individuals planning on making dietary or physical activity changes throughout study duration;
- If participating in MRI portion of study: any condition or circumstance which would prevent the participant from having an MRI (e.g. having prostheses or metal implants, tattoos, or claustrophobia)
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Sugar-sweetened beverage (SSB)
Non-nutritive sweetened beverage (NSB)
Water
The SSB intervention will consist the participants' consuming their usual serving of cans SSBs (each 355 ml, 42 grams sugar) per day. The calories of the SSB group will not be matched to allow for "real-world" substitutions using products available on the market.
The NSB intervention consists of substituting the participants' usual serving of cans SSBs with NSBs (each 355 ml, 0 grams sugar) per day. The calories of the NSB group will not be matched to allow for "real-world" substitutions using products available on the market.
The water intervention consists of substituting the participants' usual serving of cans SSBs with bottles or cans of still or sparkling water (each 355 ml bottle or can, 0 grams sugar) per day. The calories of the water group will not be matched to allow for "real-world" substitutions using products available on the market.