What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
probiotics
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Probiotics, Appetite Regulation, Gastrointestinal microbiome, Caloric Restriction, Body weight maintenance, Body composition
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
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
probiotics
placebo
Arm Description
Outcomes
Primary Outcome Measures
body composition
air displacement plethysmography (BodPod, COSMED, Italy)
Secondary Outcome Measures
appetite suppression
Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption)
body composition
Bioelectrical impedance analysis (BIA)
resting metabolic rate
indirect calorimetry
Full Information
NCT ID
NCT03287726
First Posted
September 14, 2017
Last Updated
March 3, 2021
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian University of Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03287726
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian University of Life Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Probiotics, Appetite Regulation, Gastrointestinal microbiome, Caloric Restriction, Body weight maintenance, Body composition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotics
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
body composition
Description
air displacement plethysmography (BodPod, COSMED, Italy)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
appetite suppression
Description
Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption)
Time Frame
9 months
Title
body composition
Description
Bioelectrical impedance analysis (BIA)
Time Frame
9 months
Title
resting metabolic rate
Description
indirect calorimetry
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torstein Baade Rø, phd prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32844188
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.
Results Reference
result
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What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?
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