Back to resultsProbiotic Intervention Study
Primary Purpose
Obesity, Food Addiction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Probiotic, Dietary Supplement
Eligibility Criteria
Inclusion Criteria: Ages 18-50 BMI 25-40 Male and Female Not Pregnant or Nursing Exclusion Criteria: Co-morbidities including but not limited to: 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) abdominal surgeries including weight loss surgery or partial/complete resection of stomach or bowel untreated thyroid disease neurological disease Major medical condition the PI/MD feels would put the subject at risk or interfere with data collection. Chronic pain Diagnosed DSM IV active psychiatric illness including eating disorders. Must not be active or present for at least 2 years. Participants with a positive endorsement on the MINI+ will be excluded. Using medications known to affect hunger/satiety/appetite Pregnant, lactating, postpartum less than 6months. Women of childbearing potential who are not practicing birth control or are planning to get pregnant during the study. Use of oral/IV antibiotics within the last 3 months Use of probiotics in the last 3 months. Heavy use of alcohol and drugs will be determined by a positive endorsement on the MINI+. If the MINI+ is positive for alcohol or drug dependence or abuse, the participant will be excluded. In regards to tobacco use, participants will be excluded if they smoke more than 1/2 pack per day. Cannabis use will not be exclusionary. If the MINI+ is positive for drug dependence or abuse, the participant will be excluded. Significant change in usual diet and/or weight loss of more than 10lbs in the last 2 months. Anyone taking medicines on the medication exclusion list. Non-English Speakers (due to the use of validated questionnaires and limited availability of translated copies, participants must be fluent in English so that they will be able to read and follow directions easily. Maintenance pharmacotherapies will not be exclusionary so long as they have been on a stable dose for 6months. Body weight at enrollment greater than 400lbs. Exclude from Optional MRI if: participant is unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, metallic foreign bodies, etc.).
Sites / Locations
- University of CaliforniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Differences in microbiome levels pre & post intervention - Stool
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre & post intervention - Blood
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
Secondary Outcome Measures
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.
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.
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.
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.
Systolic and Diastolic Blood Pressure
Measurement of the pressure of circulating blood at rest
Anthropometrics - BMI
Measurement of height(in) & weight(lbs), used to calculate body mass index (BMI).
Questionnaire Data - Diet
Use of validated surveys including the Food Frequency questionnaire, Food Choice Questionnaire.
Questionnaire Data
Use of validated surveys to assess ingestive behaviors, stress, health, physical activity, etc.
Anthropometrics - waist and hip circumference
Measurement of waist and hip circumference (cm).
Full Information
NCT ID
NCT06030362
First Posted
August 4, 2023
Last Updated
September 8, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT06030362
Brief Title
Probiotic Intervention Study
Official Title
Double Blinded Placebo Controlled Feasibility Study to Evaluate a Combination Probiotic in Adults With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Food Addiction
Keywords
Probiotic, Dietary Supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Dietary Supplement taken once daily for 3 months (90 days).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Dietary Supplement taken once daily for 3 months (90days).
Primary Outcome Measure Information:
Title
Differences in metabolite concentrations pre & post intervention - Stool
Description
Measurement of metabolomics via stool specimen.
Time Frame
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).
Title
Differences in metabolite concentrations pre & post intervention - Blood
Description
Measurement of metabolomics via blood specimen.
Time Frame
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).
Title
Differences in microbiome levels pre & post intervention - Stool
Description
16S RNA sequencing to measure microbiome levels via stool specimen.
Time Frame
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).
Title
Differences in microbiome levels pre & post intervention - Blood
Description
16S RNA sequencing to measure microbiome levels via blood specimen.
Time Frame
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).
Title
Differences in microbiome levels pre & post intervention - Stool
Description
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Time Frame
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).
Title
Differences in microbiome levels pre & post intervention - Blood
Description
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
Time Frame
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).
Secondary Outcome Measure Information:
Title
Differences in Subjective Stress Response - PANAS
Description
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.
Time Frame
Lasting approximately 10 minutes, measured pre & post the laboratory stress tasks, at baseline (week 0) and end of study (week 12).
Title
Changes in Autonomic Measures - Heart Rate Variability
Description
Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.
Time Frame
Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visits, lasting approximately 1 hour.
Title
Changes in Autonomic Measures - Skin Conductance
Description
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.
Time Frame
Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.
Title
Changes in Autonomic Measures - Diastolic & Systolic blood pressure
Description
Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.
Time Frame
Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.
Title
Differences in Attention/Executive Function - Color Stroop
Description
Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task.
Time Frame
Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).
Title
Differences in Attention/Executive Function - Trails A & B
Description
Between and within group differences on the time it takes to complete the Trails A & B attention/executive function lab stress task.
Time Frame
Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).
Title
Differences in Emotional Arousal System - IAPS task
Description
Between and within group differences in valence and emotional arousal ratings during the International Affective Picture System (IAPS) task.
Time Frame
Lasting approximately 15minutes, measured at baseline (week 0) and end of study (week 12).
Title
Systolic and Diastolic Blood Pressure
Description
Measurement of the pressure of circulating blood at rest
Time Frame
Measured three times, once at each in-clinic appointment (week 0, week 6, week 12).
Title
Anthropometrics - BMI
Description
Measurement of height(in) & weight(lbs), used to calculate body mass index (BMI).
Time Frame
Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
Title
Questionnaire Data - Diet
Description
Use of validated surveys including the Food Frequency questionnaire, Food Choice Questionnaire.
Time Frame
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.
Title
Questionnaire Data
Description
Use of validated surveys to assess ingestive behaviors, stress, health, physical activity, etc.
Time Frame
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.
Title
Anthropometrics - waist and hip circumference
Description
Measurement of waist and hip circumference (cm).
Time Frame
Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
Other Pre-specified Outcome Measures:
Title
Differences in Multimodal Brain Signatures
Description
Neuroimaging of a subset of participants brain via magnetic resonance imaging (MRI) procedure.
Time Frame
Optional - Measured twice, once at baseline (week 0) and once at end of study (week 12) visit. Lasting approximately 1.5hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 18-50
BMI 25-40
Male and Female
Not Pregnant or Nursing
Exclusion Criteria:
Co-morbidities including but not limited to:
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)
abdominal surgeries including weight loss surgery or partial/complete resection of stomach or bowel
untreated thyroid disease
neurological disease
Major medical condition the PI/MD feels would put the subject at risk or interfere with data collection.
Chronic pain
Diagnosed DSM IV active psychiatric illness including eating disorders. Must not be active or present for at least 2 years. Participants with a positive endorsement on the MINI+ will be excluded.
Using medications known to affect hunger/satiety/appetite
Pregnant, lactating, postpartum less than 6months.
Women of childbearing potential who are not practicing birth control or are planning to get pregnant during the study.
Use of oral/IV antibiotics within the last 3 months
Use of probiotics in the last 3 months.
Heavy use of alcohol and drugs will be determined by a positive endorsement on the MINI+. If the MINI+ is positive for alcohol or drug dependence or abuse, the participant will be excluded. In regards to tobacco use, participants will be excluded if they smoke more than 1/2 pack per day.
Cannabis use will not be exclusionary. If the MINI+ is positive for drug dependence or abuse, the participant will be excluded.
Significant change in usual diet and/or weight loss of more than 10lbs in the last 2 months.
Anyone taking medicines on the medication exclusion list.
Non-English Speakers (due to the use of validated questionnaires and limited availability of translated copies, participants must be fluent in English so that they will be able to read and follow directions easily.
Maintenance pharmacotherapies will not be exclusionary so long as they have been on a stable dose for 6months.
Body weight at enrollment greater than 400lbs.
Exclude from Optional MRI if: participant is unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, metallic foreign bodies, etc.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Vaughan, MPH
Phone
3108257206
Email
GuptaLab@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arpana Gupta, PhD
Organizational Affiliation
The Regents of the University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tien Dong, MD, PhD
Organizational Affiliation
The Regents of the University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Vaughan, MPH
Phone
310-825-7206
Email
GuptaLab@mednet.ucla.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
At this time there is no plan to make the de-identified data available for sharing with other researchers.
Learn more about this trial
Probiotic Intervention Study
We'll reach out to this number within 24 hrs