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

Laval University

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Other: Weight loss; Drug: Probiotic Formula; Drug: Placebos

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02962583

CLIN-21-012

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Daily probiotic consumption

Treatment:

Other: Weight loss

Drug: Probiotic Formula

Placebo

Placebo Comparator group

Description:

Daily placebo consumption

Treatment:

Drug: Placebos

Other: Weight loss