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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962583
• Other study ID #: CLIN-21-012
• Status: Completed
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: June 6, 2019

Study information

• Verified date: August 2020
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Other:
• Weight loss

Drug:
• Probiotic Formula

• Placebos

Locations

Country	Name	City	State
Canada	PEPS - Université Laval	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Lallemand Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline body weight at 12 weeks		12 weeks
Secondary	Change from Baseline BMI at 12 weeks		12 weeks
Secondary	Change from Baseline waist circumference data at 12 weeks		12 weeks
Secondary	Change from Baseline sagittal abdominal diameter data at 12 weeks		12 weeks
Secondary	Change from Baseline body composition at 12 weeks	DXA	12 weeks
Secondary	Change from Baseline stress level at 12 weeks	Questionnaire	12 weeks
Secondary	Change from Baseline anxiety level at 12 weeks	Questionnaire	12 weeks
Secondary	Change from Baseline depression symptoms at 12 weeks	Questionnaire	12 weeks
Secondary	Change from Baseline sleeping habits at 12 weeks	Questionnaire	12 weeks
Secondary	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
Secondary	Change from Baseline C-reactive protein at 12 weeks		12 weeks
Secondary	Change from Baseline TNF-a at 12 weeks		12 weeks
Secondary	Change from Baseline interleukin-6 at 12 weeks		12 weeks
Secondary	Change from Baseline lipopolysaccharide (LPS) at 12 weeks		12 weeks