NCT02893943

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 cardiovascular disease (CVD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

March 17, 2023

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

August 29, 2016

Last Update Submit

March 16, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body weight

    60 days

Secondary Outcomes (16)

  • Body mass index

    60 days

  • Body fat percentage

    60 days

  • Waist circumference

    60 days

  • Hip circumference

    60 days

  • Total fat mass

    60 days

  • +11 more secondary outcomes

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

1 capsule per day containing probiotics

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

1 capsule per day without probiotics

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT
Probiotics
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Rotimi Aluko, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 9, 2016

Study Start

January 1, 2017

Primary Completion

July 31, 2017

Study Completion

January 31, 2018

Last Updated

March 17, 2023

Record last verified: 2021-04

Locations

CA(1)