What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: probiotics
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotics<br> | Dietary Supplement: probiotics<br>* NYCOPRO, a multistrain probiotic (7 strains of Lactobacilli and Bifidobacteria) sold in the Norwegian pharmacies. 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month.<br>|
| Placebo Comparator: placebo<br> | Dietary Supplement: placebo<br>* Placebo 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition | air displacement plethysmography (BodPod, COSMED, Italy) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appetite suppression | Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption) | 9 months | 
| body composition | Bioelectrical impedance analysis (BIA) | 9 months | 
| resting metabolic rate | indirect calorimetry | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Appetite Regulation, Gastrointestinal microbiome, Caloric Restriction, Body weight maintenance, Body composition