Clinical trial NCT03287726: What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?
Official title: Evaluation of the Potential Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Probiotics
Appetite Regulation
Gastrointestinal microbiome
Caloric Restriction
Body weight maintenance
Body composition
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian University of Life Sciences
First posted: 2017-09-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: body composition
timeFrame: 9 months
Secondary outcomes:
measure: appetite suppression
timeFrame: 9 months
measure: body composition
timeFrame: 9 months
measure: resting metabolic rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Torstein Baade Rø, phd prof
role: STUDY_CHAIR
References:
citation: Martins C, Roekenes J, Salamati S, Gower BA, Hunter GR. Metabolic adaptation is an illusion, only present when participants are in negative energy balance. Am J Clin Nutr. 2020 Nov 11;112(5):1212-1218. doi: 10.1093/ajcn/nqaa220.