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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03287726

Collaborator

St. Olavs Hospital (Other), Norwegian University of Life Sciences (Other)

Enrollment

Location

Arms

37.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: probiotics Dietary Supplement: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2017

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: probiotics	Dietary Supplement: probiotics 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.
Placebo Comparator: placebo	Dietary Supplement: placebo 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.

Arm

Intervention/Treatment

Experimental: probiotics

Dietary Supplement: probiotics

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.

Placebo Comparator: placebo

Dietary Supplement: placebo

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.

Outcome Measures

Primary Outcome Measures

body composition [9 months]
air displacement plethysmography (BodPod, COSMED, Italy)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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