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Clinical Trials/NCT03287726
NCT03287726
Completed
Not 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 enrollmentNovember 16, 2017
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Norwegian University of Science and Technology
Enrollment
76
Locations
1
Primary Endpoint
body composition
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2017
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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