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Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese Individuals

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ClinicalTrials.gov Identifier: NCT02893943
Recruitment Status : Active, not recruiting
First Posted : September 9, 2016
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:
The aim of the study is to evaluate the potential of probiotics on weight management. It is hypothesized that the consumption of 1 capsule of probiotics daily will modulate the intestinal gut microbiota thereby reducing body weight and fat compared to those who do not consume probiotics. In addition, a diet supplemented with probiotics can be expected to be more beneficial than a diet without probiotic supplementation in impacting biomarkers of obesity-associated disorders including diabetes, hypertension and CVD.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

Detailed Description:

Overweight, obese men and women volunteers aged between 18-65 yrs with BMI greater than or equal to 25 will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized, double-blind, placebo-controlled, free-living intervention study for 60 days per study period following obtainment of informed consent. Participants will be informed to maintain their usual diets as well as their physical activity level.

After obtaining consent, participants will be randomized to receive either 1 capsule containing probiotics, or 1 capsule of placebo daily for 60 days. Compared with the probiotic capsules, the placebo contains the same carrier material and is similar in size, shape and taste.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese Individuals
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Probiotics
1 capsule per day containing probiotics
Dietary Supplement: Probiotics
Placebo Comparator: Placebo
1 capsule per day without probiotics
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Body weight [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Body mass index [ Time Frame: 60 days ]
  2. Body fat percentage [ Time Frame: 60 days ]
  3. Waist circumference [ Time Frame: 60 days ]
  4. Hip circumference [ Time Frame: 60 days ]
  5. Total fat mass [ Time Frame: 60 days ]
  6. Total lean mass [ Time Frame: 60 days ]
  7. Gut microbiome [ Time Frame: 60 days ]
    Stool samples will be collected from participants to analyze intestinal microbiota community composition

  8. Blood pressure [ Time Frame: 60 days ]
  9. Blood total cholesterol [ Time Frame: 60 days ]
  10. Blood low-density lipoprotein cholesterol [ Time Frame: 60 days ]
  11. Blood high-density lipoprotein cholesterol [ Time Frame: 60 days ]
  12. Blood triglycerides [ Time Frame: 60 days ]
  13. Blood glucose [ Time Frame: 60 days ]
  14. Blood insulin [ Time Frame: 60 days ]
  15. Aspartate aminotransferase [ Time Frame: 60 days ]
  16. Alanine transaminase [ Time Frame: 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight, obese men and women volunteers aged between 18-65 yrs
  • BMI equal to or greater than 25
  • Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
  • Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substances for control body weight.
  • Able to provide informed consent.
  • Women of childbearing potential with a negative pregnancy test at screening.

Exclusion Criteria

  • BMI greater than 35
  • Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
  • Those currently taking (or have taken within the last 3 months) cholesterol-lowering, triglyceride-lowering or hypertension medications.
  • Those currently taking (or have taken within the last 3 months) lipid-lowering supplements, (e.g., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc).
  • Smokers.
  • Allergic to milk, soy, or yeast (some of our probiotics strains may contains these items).
  • Use of another investigational product within 3 months of the screening visit.
  • Positive pregnancy test in women of child-bearing potential.
  • 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.
  • Use of any other treatments (medication or nutritional program) affecting body weight, food intake and/or energy expenditure.
  • Menopausal women.
  • Weight gain or loss of at least 10lbs in previous three months.
  • Uncontrolled angina within the past six months.
  • 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 HIV/AIDS).
  • 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.
  • History of drug or alcohol (> 2 drinks daily) abuse.
  • Abnormal thyroid hormone levels.
  • Immune-compromised conditions.
  • Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain (past week and chronic).
  • Participants exercising > 15 miles/wk or 4,000 kcal/wk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893943


Locations
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Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Lallemand Health Solutions
Investigators
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Principal Investigator: Peter Jones, PhD University of Manitoba

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02893943     History of Changes
Other Study ID Numbers: B2016:033
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms