Probiotic Intervention Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of California, Los Angeles

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    Dietary supplement

    Dietary Supplement taken once daily for 3 months (90 days).

  • Placebo

    Dietary supplement

    Dietary Supplement taken once daily for 3 months (90days).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ProbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Differences in metabolite concentrations pre & post intervention - Stool

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).
2

Differences in metabolite concentrations pre & post intervention - Blood

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).
3

Differences in microbiome levels pre & post intervention - Stool

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).
4

Differences in microbiome levels pre & post intervention - Blood

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).

Secondary outcomes

1

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.

Time frame
Lasting approximately 10 minutes, measured pre & post the laboratory stress tasks, at baseline (week 0) and end of study (week 12).
2

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.

Time frame
Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visits, lasting approximately 1 hour.
3

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.

Time frame
Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.
4

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.

Time frame
Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.

Other outcomes

1

Differences in Multimodal Brain Signatures

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.

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