Status:
COMPLETED
What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Norwegian University of Life Sciences
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- 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
- consumption of probiotics 6 months before taking part in the study
- pregnant
- 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
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03287726
Start Date
November 16 2017
End Date
December 31 2020
Last Update
March 4 2021
Active Locations (1)
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1
St Olavs Hospital
Trondheim, Norway