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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: placebo; Dietary Supplement: probiotics

• Registration Number: NCT03287726
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Study Start: 2017-11-16
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
probiotics	probiotics	-

Primary Outcome Measures

Name	Time	Method
body composition	9 months	air displacement plethysmography (BodPod, COSMED, Italy)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway