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

March 3, 2021 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Norwegian University of Life Sciences

Investigators

  • Study Chair: Torstein Baade Rø, phd prof, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1297-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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