Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03287726
NCT03287726CompletedNot Applicable

Evaluation of the Potential Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity

Norwegian University of Science and Technology1 site in 1 country76 target enrollmentStarted: November 16, 2017Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
body composition
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Weight loss maintenance is the biggest challenge in obesity management, with the majority of weight-reduced individuals experiencing weight regain. The intake of probiotics has been shown to help in weight loss, but its potential in maximizing weight loss maintenance remains unknown. Therefore, the main aim of this study is to investigate the impact of probiotic consumption on weight loss maintenance. Secondary aims are to investigate if the intake of probiotics influences gut microbiota, cardio-metabolic profile, appetite and inflammatory markers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •class I or II obesity (30 kg/m2 < BMI > 40 kg/m2)
  • •weight stable (<2 kg variation in weight within the last 3 months)
  • •not currently dieting to lose weight
  • •dietary intervention of 1000 kcal energy restriction for 8 weeks using a powder based low energy diet product, followed by 4 week weight stabilization phase (re-introduction of food)
  • •women who are either post-menopausal, taking oral contraceptives or with a normal cycle (28 ± 2 days)

Exclusion Criteria

  • •consumption of probiotics 6 months before taking part in the study
  • •breast-feeding
  • •drug or alcohol abuse within the last two years
  • •currently taking medication known to affect appetite or induce weight loss
  • •enrolled in another obesity treatment program
  • •history of psychological disorders
  • •having had bariatric surgery
  • •metabolic diseases (such as hypo/hyperthyroidism and diabetes type 1 or 2)
  • •eating disorders
  • •lactose intolerance
  • •gastrointestinal (particularly cholelithiasis), kidney, liver, lung, cardiovascular disease
  • •malignancies

Arms & Interventions

placebo

Placebo Comparator

Intervention: placebo (Dietary Supplement)

probiotics

Experimental

Intervention: probiotics (Dietary Supplement)

Outcomes

Primary Outcomes

body composition

Time Frame: 9 months

air displacement plethysmography (BodPod, COSMED, Italy)

Secondary Outcomes

  • appetite suppression(9 months)
  • resting metabolic rate(9 months)
  • body composition(9 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese IndividualsObesity
NCT02893943University of Manitoba30
Completed
Not Applicable
Probiotic Supplementation on Weight LossBariatric Surgery Candidate
NCT03832439Mayo Clinic18
Completed
Not Applicable
The Effect of Probiotics on Obesity. Metabolic Endotoxemia and InflammationMetabolic Syndrome
NCT03883685University of Sharjah80
Unknown
Phase 4
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in AdultsWeight Reduction
NCT04910620National Taiwan University Hospital96
Recruiting
Phase 3
Probiotics trialGastric cancer
JPRN-jRCTs031200004omura Eiji80