The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants

Study Overview
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Brief Summary
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Limited interventional human studies suggest that probiotic supplementation may be a beneficial strategy for promoting weight loss when added to a nutritional intervention via their effects on lipid absorption and metabolic signaling molecules. The purpose of this study is to evaluate the effects of addition of a probiotic supplementation to a weight loss intervention on body weight, body composition and overall health in overweight adults.

Official Title
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The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants: A Randomized, Double-blind, Placebo Controlled Study

Conditions
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Obesity

Intervention / Treatment
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* Other: Weight loss
* Drug: Probiotic Formula
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 55 years BMI between 27.0 and 39.9 kg/m2 Sedentary to moderate active (less than 30 minutes of physical activity, 3 times per week) Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substance for body weight control Willingness and ability to provide informed consent in French Willingness to receive random assignment to probiotic or placebo supplementation Committed to losing weight over the 12-week study period Exclusion Criteria: Smokers Use of another investigational product within three months of the pre-baseline period. Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months. Women of child-bearing potential not using effective contraception which include: Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants Intrauterine devices (IUD) or Intrauterine system (IUS) Tubal ligation Vasectomy of partner Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap) Positive pregnancy test in women of child-bearing potential Menopausal women Allergic to milk, soy, or yeast Weight gain or loss of at least 10 lbs in previous three months Inflammatory bowel syndrome, celiac disease, short bowel syndrome, or any other malabsorptive syndrome Uncontrolled angina within the past six months Insulin-dependent diabetes (oral medications are not exclusionary) Serious and/or unstable medical conditions (e.g. cardiovascular, renal, lung, psychiatric illness, bleeding disorders, etc.) Cancer treatment (radiation, chemotherapy, surgery) within past six months or any other treatment or condition known to weaken the immune system (such as systemic corticosteroids or HIVIAIDS). Any physical condition deemed likely to significantly interfere with individuals' ability to participate in a nutritional intervention. Currently or at any point during the study participating in Weight Watcher's or another weight loss program or taking a medication for weight loss. Under antibiotics or treatments (medication or nutritional program) affecting body weight Intake and/or energy expenditure History of drug or alcohol (> 9 drinks weekly) abuse Abnormal thyroid hormone levels Immune-compromised conditions Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Daily probiotic consumption | Other: Weight loss<br> <br> Drug: Probiotic Formula<br> <br> |
| Placebo Comparator: Placebo<br>Daily placebo consumption | Other: Weight loss<br> <br> Drug: Placebos<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline body weight at 12 weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline BMI at 12 weeks |  | 12 weeks | 
| Change from Baseline waist circumference data at 12 weeks |  | 12 weeks | 
| Change from Baseline sagittal abdominal diameter data at 12 weeks |  | 12 weeks | 
| Change from Baseline body composition at 12 weeks | DXA | 12 weeks | 
| Change from Baseline stress level at 12 weeks | Questionnaire | 12 weeks | 
| Change from Baseline anxiety level at 12 weeks | Questionnaire | 12 weeks | 
| Change from Baseline depression symptoms at 12 weeks | Questionnaire | 12 weeks | 
| Change from Baseline sleeping habits at 12 weeks | Questionnaire | 12 weeks | 
| Change from Baseline intestinal microbiota composition at 12 weeks | Changes in the concentrations of the probiotic strains in the stools will be measured with strain specific DNA in fecal samples. | 12 weeks | 
| Change from Baseline C-reactive protein at 12 weeks |  | 12 weeks | 
| Change from Baseline TNF-a at 12 weeks |  | 12 weeks | 
| Change from Baseline interleukin-6 at 12 weeks |  | 12 weeks | 
| Change from Baseline lipopolysaccharide (LPS) at 12 weeks |  | 12 weeks |