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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Dietary Supplement taken once daily for 3 months (90 days). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in metabolite concentrations pre & post intervention - Stool | Measurement of metabolomics via stool specimen. | Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12). |
| Differences in metabolite concentrations pre & post intervention - Blood | Measurement of metabolomics via blood specimen. | Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12). |
| Differences in microbiome levels pre & post intervention - Stool | 16S RNA sequencing to measure microbiome levels via stool specimen. | Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12). |
| Differences in microbiome levels pre & post intervention - Blood | 16S RNA sequencing to measure microbiome levels via blood specimen. | Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12). |
| Differences in microbiome levels pre & post intervention - Stool | Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen. | Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12). |
| Differences in microbiome levels pre & post intervention - Blood |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Multimodal Brain Signatures | Neuroimaging of a subset of participants brain via magnetic resonance imaging (MRI) procedure. | Optional - Measured twice, once at baseline (week 0) and once at end of study (week 12) visit. Lasting approximately 1.5hours. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Vaughan, MPH | Contact | 3108257206 | GuptaLab@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Arpana Gupta, PhD | The Regents of the University of California, Los Angeles | Principal Investigator |
| Tien Dong, MD, PhD | The Regents of the University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Recruiting | Los Angeles | California | 90095 | United States |
At this time there is no plan to make the de-identified data available for sharing with other researchers.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000073932 | Food Addiction |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo |
| Dietary Supplement |
Dietary Supplement taken once daily for 3 months (90days). |
|
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
| Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12). |
| Lasting approximately 10 minutes, measured pre & post the laboratory stress tasks, at baseline (week 0) and end of study (week 12). |
| 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. | Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visits, lasting approximately 1 hour. |
| 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. | Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour. |
| 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. | Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour. |
| Differences in Attention/Executive Function - Color Stroop | Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task. | Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12). |
| Differences in Attention/Executive Function - Trails A & B | Between and within group differences on the time it takes to complete the Trails A & B attention/executive function lab stress task. | Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12). |
| Differences in Emotional Arousal System - IAPS task | Between and within group differences in valence and emotional arousal ratings during the International Affective Picture System (IAPS) task. | Lasting approximately 15minutes, measured at baseline (week 0) and end of study (week 12). |
| Systolic and Diastolic Blood Pressure | Measurement of the pressure of circulating blood at rest | Measured three times, once at each in-clinic appointment (week 0, week 6, week 12). |
| Anthropometrics - BMI | Measurement of height(in) & weight(lbs), used to calculate body mass index (BMI). | Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12) |
| Questionnaire Data - Diet | Use of validated surveys including the Food Frequency questionnaire, Food Choice Questionnaire. | Self-Reported by the participant at home, collected 3 times (1) before beginning the dietary supplement, (2) at least 1 week before the mid-study appointment, and (3) within 1 week of finishing the 90-day dietary supplement. |
| Questionnaire Data | Use of validated surveys to assess ingestive behaviors, stress, health, physical activity, etc. | Self-Reported by the participant at home, collected 3 times (1) before beginning the dietary supplement, (2) at least 1 week before the mid-study appointment, and (3) within 1 week of finishing the 90-day dietary supplement. |
| Anthropometrics - waist and hip circumference | Measurement of waist and hip circumference (cm). | Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D019602 |
| Food and Beverages |