ObesityNCT06030362
Probiotic Intervention Study
A study testing Probiotic in people with Obesity and Food Addiction, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Food Addiction
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2023to 19 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-50
- BMI 25-40
- Male and Female
- Not Pregnant or Nursing
Who cannot join
- 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
Show all 24Show fewer
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
Los Angeles, California, 90095
About this study
Official title: Double Blinded Placebo Controlled Feasibility Study to Evaluate a Combination Probiotic in Adults With Obesity
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.
- Conditions
- Obesity, Food Addiction
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic, Dietary Supplement
- Medical subject headings
- Obesity, Food Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Dietary Supplement taken once daily for 3 months (90 days).
PlaceboDietary supplement
Dietary Supplement taken once daily for 3 months (90days).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Not described Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in metabolite concentrations pre & post intervention - Stool
Measurement of metabolomics via stool specimen.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
Measured: 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 outcomes (12)
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.
Measured: 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: 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: 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: 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.
Measured: 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.
Measured: 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.
Measured: 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: 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: 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.
Measured: 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.
Measured: 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: Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start18 Jul 2023
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arpana Church, University of California, Los Angeles
- Investigators
- Arpana Gupta, PhD, Principal investigator, The Regents of the University of California, Los AngelesTien Dong, MD, PhD, Principal investigator, The Regents of the University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030362
- Sponsor's protocol ID
- IRB 22-000796
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan to make the de-identified data available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Placebo Controlled Feasibility Study to Evaluate a Combination Probiotic in Adults With Obesity
- ClinicalTrials.gov ID
- NCT06030362
- Acronym / sponsor ID
- IRB 22-000796
- Conditions
- Obesity, Food Addiction
- Keywords
- Probiotic, Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-50
- BMI 25-40
- Male and Female
- Not Pregnant or Nursing
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticDietary Supplement taken once daily for 3 months (90 days). | Dietary supplement | Probiotic |
| PlaceboDietary Supplement taken once daily for 3 months (90days). | Dietary supplement | Placebo |
Primary outcome
Differences in metabolite concentrations pre & post intervention - Stool
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).
Measurement of metabolomics via stool specimen.
Differences in metabolite concentrations pre & post intervention - Blood
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).
Measurement of metabolomics via blood specimen.
Differences in microbiome levels pre & post intervention - Stool
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).
16S RNA sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre & post intervention - Blood
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).
16S RNA sequencing to measure microbiome levels via blood specimen.
Differences in microbiome levels pre & post intervention - Stool
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).
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre & post intervention - Blood
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).
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
12 secondary outcomes
Differences in Subjective Stress Response - PANAS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).
Differences in Attention/Executive Function - Trails A & B
Time frame: Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).
Differences in Emotional Arousal System - IAPS task
Time frame: Lasting approximately 15minutes, measured at baseline (week 0) and end of study (week 12).
Systolic and Diastolic Blood Pressure
Time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, week 12).
Anthropometrics - BMI
Time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
Questionnaire Data - Diet
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.
Questionnaire Data
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.
Anthropometrics - waist and hip circumference
Time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. At this time there is no plan to make the de-identified data available for sharing with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arpana Gupta, PhD principal investigator
The Regents of the University of California, Los Angeles
Tien Dong, MD, PhD principal investigator
The Regents of the University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Obesity and Food Addiction, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in metabolite concentrations pre & post intervention - Stool (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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.