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

• Status: Completed
• Trial end date: 2019-06-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laval University
• Collaborator: Lallemand Health Solutions

Criteria

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