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The purpose of this study is to collect data to examine whether short-term consumption of non-caloric artificial sweeteners (NCASs), such as saccharin, can lead to changes in blood sugar levels and in the composition of the bacteria in the large intestine.
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Inclusion criteria
Exclusion criteria
Known coronary artery disease, angina or congestive heart failure
Type 1 or Type 2 Diabetes (A1c ≥6.5%)
Bleeding disorders
Hemoglobin level < 12.5 g/dL for women; hemoglobin level < 13.0 g/dL for men
Acute or chronic infections
Hepatitis and/or cirrhosis
Severe asthma or chronic obstructive pulmonary disease
Renal insufficiency or nephritis (creatinine > 1.6 mg/dl)
Prior bariatric surgery
Inflammatory bowel disease or malabsorption
Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
Psychiatric disorders or eating disorders
Cushing's disease or syndrome
Untreated or inadequately controlled hypo- or hyperthyroidism (abnormal TSH)
Active rheumatoid arthritis or other inflammatory rheumatic disorder
Pregnant or nursing women
Smoking (smoking within the past 3 months)
Less than 4 bowel movements per week
Known hypersensitivity to saccharin, lactisole or any of its excipients.
Excluded medications include but are not limited to:
Anti-diabetic agents
Oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable)
Antibiotic use (within the past 3 months)
Other drugs known to affect immune or metabolic function
Orlistat, phentermine, topiramate or other weight loss or anorectic agents (tricyclic antidepressants, atypical antipsychotics or other psychiatric drugs with effects on body weight)
Primary purpose
Allocation
Interventional model
Masking
102 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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