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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-06-06

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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic

Daily probiotic consumption

Group Type EXPERIMENTAL

Weight loss

Intervention Type OTHER

Probiotic Formula

Intervention Type DRUG

Placebo

Daily placebo consumption

Group Type PLACEBO_COMPARATOR

Weight loss

Intervention Type OTHER

Placebos

Intervention Type DRUG

Interventions

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Weight loss

Intervention Type OTHER

Probiotic Formula

Intervention Type DRUG

Placebos

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes