<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03287726</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1297-10</org_study_id>
    <nct_id>NCT03287726</nct_id>
  </id_info>
  <brief_title>What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?</brief_title>
  <official_title>Evaluation of the Potential Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian University of Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Weight loss maintenance is the biggest challenge in obesity management, with the majority of&#xD;
      weight-reduced individuals experiencing weight regain. The intake of probiotics has been&#xD;
      shown to help in weight loss, but its potential in maximizing weight loss maintenance remains&#xD;
      unknown. Therefore, the main aim of this study is to investigate the impact of probiotic&#xD;
      consumption on weight loss maintenance. Secondary aims are to investigate if the intake of&#xD;
      probiotics influences gut microbiota, cardio-metabolic profile, appetite and inflammatory&#xD;
      markers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>body composition</measure>
    <time_frame>9 months</time_frame>
    <description>air displacement plethysmography (BodPod, COSMED, Italy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>appetite suppression</measure>
    <time_frame>9 months</time_frame>
    <description>Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition</measure>
    <time_frame>9 months</time_frame>
    <description>Bioelectrical impedance analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting metabolic rate</measure>
    <time_frame>9 months</time_frame>
    <description>indirect calorimetry</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>probiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>probiotics</intervention_name>
    <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.</description>
    <arm_group_label>probiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <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.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  class I or II obesity (30 kg/m2 &lt; BMI &gt; 40 kg/m2)&#xD;
&#xD;
          -  weight stable (&lt;2 kg variation in weight within the last 3 months)&#xD;
&#xD;
          -  not currently dieting to lose weight&#xD;
&#xD;
          -  dietary intervention of 1000 kcal energy restriction for 8 weeks using a powder based&#xD;
             low energy diet product, followed by 4 week weight stabilization phase&#xD;
             (re-introduction of food)&#xD;
&#xD;
          -  women who are either post-menopausal, taking oral contraceptives or with a normal&#xD;
             cycle (28 ± 2 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  consumption of probiotics 6 months before taking part in the study&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  breast-feeding&#xD;
&#xD;
          -  drug or alcohol abuse within the last two years&#xD;
&#xD;
          -  currently taking medication known to affect appetite or induce weight loss&#xD;
&#xD;
          -  enrolled in another obesity treatment program&#xD;
&#xD;
          -  history of psychological disorders&#xD;
&#xD;
          -  having had bariatric surgery&#xD;
&#xD;
          -  metabolic diseases (such as hypo/hyperthyroidism and diabetes type 1 or 2)&#xD;
&#xD;
          -  eating disorders&#xD;
&#xD;
          -  lactose intolerance&#xD;
&#xD;
          -  gastrointestinal (particularly cholelithiasis), kidney, liver, lung, cardiovascular&#xD;
             disease&#xD;
&#xD;
          -  malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torstein Baade Rø, phd prof</last_name>
    <role>Study Chair</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>32844188</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Probiotics</keyword>
  <keyword>Appetite Regulation</keyword>
  <keyword>Gastrointestinal microbiome</keyword>
  <keyword>Caloric Restriction</keyword>
  <keyword>Body weight maintenance</keyword>
  <keyword>Body composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03287726
org study id: 2016/1297-10
nct id: NCT03287726
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: body composition
time frame: 9 months
description: air displacement plethysmography (BodPod, COSMED, Italy)
measure: appetite suppression
time frame: 9 months
description: Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption)
measure: body composition
time frame: 9 months
description: Bioelectrical impedance analysis (BIA)
measure: resting metabolic rate
time frame: 9 months
description: indirect calorimetry
arm group label: probiotics
arm group type: Experimental
arm group label: placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: probiotics
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.
arm group label: probiotics
intervention type: Dietary Supplement
intervention name: placebo
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.
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Torstein Baade Rø, phd prof
role: Study Chair
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
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.
PMID: 32844188
responsible party type: Sponsor
mesh term: Obesity
mesh term: Weight Loss
sharing ipd: Undecided