About this trial
The current standard of care for obesity is the optimal management of comorbid conditions such as diabetes and hyperlipidemia, and counseling on diet, weight loss, or increased physical activity programs. However, lifestyle, diet, and behavioral interventions may provide between 7-10% reduction in initial weight and even fewer with long-term weight loss. In severely obese patients (BMI\>40 or BMI\>35 with comorbidities), bariatric surgery is also a potential treatment, but there is a high barrier for patients to undergo surgery for weight loss. These barriers include an aversion to major abdominal surgery, long recovery time, potential risk of vitamin deficiency, and risk for abdominal pain. For these reasons, there is a paramount need for other treatments for obesity and for food addiction.
The current standard of care for obesity and food addiction is difficult to implement and lacks sustained efficacy. Most struggle to complete treatment, lose minimal weight, lack sustained weight loss, and engage in the well-known "YoYo" diet phenomenon. While bariatric surgery is currently the only effective treatment for obesity, there are several barriers associated with it such as eligibility requirements, invasiveness, difficult recovery, and cost making it not readily available for everyone. Some approved medications that help with obesity, such as orlistat, lorcaserin, or naltrexone-bupropion, have not been widely adopted by providers or patients due to their limited responses and adverse side effects. Probiotic cocktails have shown to be safe with little to no side effects. Preclinical models of probiotics demonstrate the ability to curb obesity in animal models. Therefore, a probiotic that is able to show significant weight loss along with lifestyle modifications would be highly adopted and desirable.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18-50
BMI 25-40
Male and Female
Not Pregnant or Nursing
Disqualifiers
Type 1 (insulin dependent) diabetes
vascular disease
drastic weight loss (more than 10lbs over the preceding 2months)
frequent strenuous exercise (i.e. marathon runners/heavy weight lifting)
Trial design
Parallel
Treatments tested in this trial
Probiotic
Dietary supplementDietary Supplement taken once daily for 3 months (90 days).
Placebo
Dietary supplementDietary Supplement taken once daily for 3 months (90days).
Treatment groups
Trial outcomes
Primary outcomes
Differences in metabolite concentrations pre & post intervention - Stool
Measurement of metabolomics via stool specimen.
Differences in metabolite concentrations pre & post intervention - Blood
Measurement of metabolomics via blood specimen.
Differences in microbiome levels pre & post intervention - Stool
16S RNA sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre & post intervention - Blood
16S RNA sequencing to measure microbiome levels via blood specimen.
Secondary outcomes
Differences in Subjective Stress Response - PANAS
Between and within group differences on the negative affect subscale from the Brief Positive Affect and Negative Affect Scale (PANAS) before and after the laboratory stress tasks. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.
Changes in Autonomic Measures - Heart Rate Variability
Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.
Changes in Autonomic Measures - Skin Conductance
Between and within group differences in overall average change in skin conductance response (SCR) pre and post each laboratory stress task measured using BIOPAC GSR (galvanized skin response) 100C system. Measured in Hz.
Changes in Autonomic Measures - Diastolic & Systolic blood pressure
Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.
Other outcomes
Differences in Multimodal Brain Signatures
Neuroimaging of a subset of participants brain via magnetic resonance imaging (MRI) procedure.
Sponsors and contacts
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