xml: <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/NCT06001632</url>
    </required_header>
    <id_info>
      <org_study_id>U Glasgow</org_study_id>
      <nct_id>NCT06001632</nct_id>
    </id_info>
    <brief_title>Changes in Muscle Strength, Inflammatory Markers, and Body Composition in Response to Alternate Day Fasting Combined With Krill Oil Supplementation in Adults With Overweight and Obesity</brief_title>
    <official_title>Changes in Muscle Strength, Inflammatory Markers, and Body Composition in Response to Alternate Day Fasting Combined With Krill Oil Supplementation in Adults With Overweight and Obesity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Glasgow</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Glasgow</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>
        The goal of this double-blind, randomised, controlled trial is to determine the effects of LC&#xD;
        n-3 PUFAs supplementation on changes in body composition and muscle strength during body&#xD;
        weight loss and body weight maintenance among healthy adults living with overweight and&#xD;
        obesity. The main research questions:&#xD;
  &#xD;
          -  Is supplementation with LC n-3 PUFAs during dietary weight loss intervention&#xD;
             (alternative-day fasting) attenuate the reduction in fat-free mass and muscle strength?&#xD;
  &#xD;
          -  Is supplementation with LC n-3 PUFAs during dietary weight loss intervention&#xD;
             (alternative-day fasting) provide additional impact on appetite related hormones&#xD;
             (Acylated ghrelin, GLP-1, and PYY) and cardiometabolic risk factors (Post prandial&#xD;
             inflammatory markers and Triglycerides)? Participants will be randomly assigned to a&#xD;
             PLACEBO (Mix-vegetables oil) or LC n-3 PUFAs group (krill oil) (1:1 basis). Both groups&#xD;
             will follow a dietary weight loss intervention (Alternate-day fasting).&#xD;
  &#xD;
        The study will last for 20 weeks that divided into 3 phases: four weeks of the preparation&#xD;
        phase, eight weeks of body weight loss phase (Alternate Day Fasting), followed by eight weeks&#xD;
        of body weight maintenance phase (regular diet).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During the preparation phase, participants will be asked to take 4g/d krill oil capsules or&#xD;
        placebo oil (mixed vegetable oil) with their healthy diet (their usual diet) for a period of&#xD;
        4 weeks. After the completion of the four weeks of the preparation phase, the weight loss&#xD;
        intervention (Alternate Day Fasting) will start, and it last for eight weeks. Then, after the&#xD;
        weight loss intervention, the weight maintenance phase will start, and it takes a period of 8&#xD;
        weeks until the end of the trial (20 weeks - study completion).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 28, 2022</start_date>
    <completion_date type="Anticipated">March 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2023</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>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in fat-free mass</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat-free mass.&#xD;
  The changes in fat-free mass will be measured by using a deuterium oxide water (D2O) technique. This technique has been used for the past 50 years to estimate total body water (TBW), which is then used to calculate fat-free mass (FFM) in kg.&#xD;
  The investigators will take two saliva samples from participants in each visit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle function by Handgrip strength</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>The Jamar hydraulic Hand dynamometer, which is a portable instrument used in clinical and research settings to precisely measure grip strength and hand function, will be used to measure handgrip strength. It has an adjustable handle that contains five grip position to suit different hand sizes and preferences. It measures the amount of force that a hand can squeeze around the dynamometer, which in term used to predict the overall muscle strength. The hand-held hydraulic system contains a measurement range of 0 to 200 pounds of force (0 to 90 kilograms), making it appropriate for testing hand grip strength.&#xD;
  The dynamometer will be adjusted for participant's hand size. Then, the participant will be asked to perform as much grip pressure as possible for two to three seconds. The subjects will receive verbal guidance from the examiner to start and finish the grip test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chair rising test</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>The chair rising test will be used to asses physical performance. The subjects will be asked to sit on a chair without armrests and perform a rising from a chair to a full standing position (standing fully erect to a straight and upright position) and then sitting down again as quickly as possible five times with recording time, with arms folded across the chest.&#xD;
  The chair rising test will be based on seconds (s).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fat mass</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat mass.&#xD;
  The changes in fat mass will be measured by using a deuterium oxide water (D2O) technique. This technique has been used for the past 50 years to estimate total body water (TBW), which is then used to calculate fat mass in kg.&#xD;
  The investigators will take two saliva samples from participants in each visit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on satiety hormone (GLP-1).&#xD;
  The measurements of Plasma GLP-1 concentrations will be determined using the ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).by All analyses will be performed according to the manufacturer's protocol and instructions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appetite related hormone [ Peptide YY (PYY)]</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on satiety hormone (PYY).&#xD;
  The measurements of Plasma PYY concentrations will be determined using ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).&#xD;
  All analyses will be performed according to the manufacturer's protocol and instructions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appetite related hormone [ Acylated Ghrelin]</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on hunger hormone (Acylated Ghrelin).&#xD;
  The measurements of Plasma Acylated Ghrelin concentrations will be determined using ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).&#xD;
  All analyses will be performed according to the manufacturer's protocol and instructions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiometabolic risk factor (Triglycerides)</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>Plasma concentration of Triglycerides levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiometabolic risk factor (Insulin)</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>ELISA kits (Thermo Fischer, Vienna, Austria) will be used to measure concentrations of plasma insulin (Mercodia AB, Uppsala, Sweden).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiometabolic risk factor (Glucose)</measure>
      <time_frame>4 weeks, 12 weeks, and 20 weeks</time_frame>
      <description>Glucose levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).&#xD;
  HOMA-IR values will be calculated using the equation developed by Matthews and colleagues (Matthews, 1985).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Obesity Associated Disorder</condition>
    <arm_group>
      <arm_group_label>Krill oil capsules (LC n-3 PUFAs)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vegetable oil capsules</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>4g/day of mixed vegetable oil (a mixture of olive oil (extra virgin, cold-pressed), maize oil (refined), palm kernel oil (refined) and medium-chain triglycerides, in the ratio 4:4:3:2).</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>krill oil (SuperbaBoostTM)</intervention_name>
      <description>4 g/day of Krill oil supplements (LC n-3 PUFAs) (1g capsule containing 191mg EPA, 94mg DHA and 78mg choline).</description>
      <arm_group_label>Krill oil capsules (LC n-3 PUFAs)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>4g/day of mixed vegetable oil</intervention_name>
      <description>vegetable oil capsules (mixture of olive oil (extra virgin, cold-pressed), maize oil (refined), palm kernel oil (refined) and medium-chain triglycerides, in the ratio 4:4:3:2).</description>
      <arm_group_label>Vegetable oil capsules</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy (male/female)&#xD;
  &#xD;
            -  body mass index (BMI) of 25 - 39.9 kg/m2&#xD;
  &#xD;
            -  Aged between 25 and 65 years&#xD;
  &#xD;
            -  stable body weight for at least three months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
            -  Food allergy&#xD;
  &#xD;
            -  On any dietary supplements or dietary regimes at the time of the study&#xD;
  &#xD;
            -  Participants with systolic/diastolic &lt;90/60 mmHg and &gt;140/90 mmHg&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mansour Alblaji</last_name>
      <role>Principal Investigator</role>
      <affiliation>Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dalia Malkova, PhD</last_name>
      <phone>07753433971</phone>
      <email>Dalia.Malkova@glasgow.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mansour Alblaji</last_name>
      <phone>07310647742</phone>
      <email>m.alblaji.1@research.gla.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Glasgow, New Lister Building</name>
        <address>
          <city>Glasgow</city>
          <state>Scotland</state>
          <zip>G31 2ER</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mansour Alblaji</last_name>
        <phone>07310647742</phone>
        <email>mansourghazi1411@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Glasgow</investigator_affiliation>
      <investigator_full_name>Dr Dalia Malkova</investigator_full_name>
      <investigator_title>Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary &amp; Life Sciences University of Glasgow</investigator_title>
    </responsible_party>
    <keyword>Obesity</keyword>
    <keyword>Cardiometabolic risk factors</keyword>
    <keyword>Fat mass</keyword>
    <keyword>Fat free mass</keyword>
    <keyword>Body composition</keyword>
    <keyword>Muscle strength</keyword>
    <keyword>LCn-3PUFA</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The study will published in scientific journal upon finished</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001632
  org study id: U Glasgow
  nct id: NCT06001632
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this double-blind, randomised, controlled trial is to determine the effects of LC
        n-3 PUFAs supplementation on changes in body composition and muscle strength during body
        weight loss and body weight maintenance among healthy adults living with overweight and
        obesity. The main research questions:
  
          -  Is supplementation with LC n-3 PUFAs during dietary weight loss intervention
             (alternative-day fasting) attenuate the reduction in fat-free mass and muscle strength?
  
          -  Is supplementation with LC n-3 PUFAs during dietary weight loss intervention
             (alternative-day fasting) provide additional impact on appetite related hormones
             (Acylated ghrelin, GLP-1, and PYY) and cardiometabolic risk factors (Post prandial
             inflammatory markers and Triglycerides)? Participants will be randomly assigned to a
             PLACEBO (Mix-vegetables oil) or LC n-3 PUFAs group (krill oil) (1:1 basis). Both groups
             will follow a dietary weight loss intervention (Alternate-day fasting).
  
        The study will last for 20 weeks that divided into 3 phases: four weeks of the preparation
        phase, eight weeks of body weight loss phase (Alternate Day Fasting), followed by eight weeks
        of body weight maintenance phase (regular diet).
  During the preparation phase, participants will be asked to take 4g/d krill oil capsules or
        placebo oil (mixed vegetable oil) with their healthy diet (their usual diet) for a period of
        4 weeks. After the completion of the four weeks of the preparation phase, the weight loss
        intervention (Alternate Day Fasting) will start, and it last for eight weeks. Then, after the
        weight loss intervention, the weight maintenance phase will start, and it takes a period of 8
        weeks until the end of the trial (20 weeks - study completion).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Changes in fat-free mass
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat-free mass.
  The changes in fat-free mass will be measured by using a deuterium oxide water (D2O) technique. This technique has been used for the past 50 years to estimate total body water (TBW), which is then used to calculate fat-free mass (FFM) in kg.
  The investigators will take two saliva samples from participants in each visit.
  measure: Muscle function by Handgrip strength
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: The Jamar hydraulic Hand dynamometer, which is a portable instrument used in clinical and research settings to precisely measure grip strength and hand function, will be used to measure handgrip strength. It has an adjustable handle that contains five grip position to suit different hand sizes and preferences. It measures the amount of force that a hand can squeeze around the dynamometer, which in term used to predict the overall muscle strength. The hand-held hydraulic system contains a measurement range of 0 to 200 pounds of force (0 to 90 kilograms), making it appropriate for testing hand grip strength.
  The dynamometer will be adjusted for participant's hand size. Then, the participant will be asked to perform as much grip pressure as possible for two to three seconds. The subjects will receive verbal guidance from the examiner to start and finish the grip test.
  measure: Chair rising test
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: The chair rising test will be used to asses physical performance. The subjects will be asked to sit on a chair without armrests and perform a rising from a chair to a full standing position (standing fully erect to a straight and upright position) and then sitting down again as quickly as possible five times with recording time, with arms folded across the chest.
  The chair rising test will be based on seconds (s).
  measure: Fat mass
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: To assess the effect of supplementation with LCn-3 PUFA during caloric restriction on the changes of fat mass.
  The changes in fat mass will be measured by using a deuterium oxide water (D2O) technique. This technique has been used for the past 50 years to estimate total body water (TBW), which is then used to calculate fat mass in kg.
  The investigators will take two saliva samples from participants in each visit.
  measure: Appetite related hormone [Glucagon-like peptide 1 (GLP-1)]
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on satiety hormone (GLP-1).
  The measurements of Plasma GLP-1 concentrations will be determined using the ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).by All analyses will be performed according to the manufacturer's protocol and instructions.
  measure: Appetite related hormone [ Peptide YY (PYY)]
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on satiety hormone (PYY).
  The measurements of Plasma PYY concentrations will be determined using ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).
  All analyses will be performed according to the manufacturer's protocol and instructions.
  measure: Appetite related hormone [ Acylated Ghrelin]
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: The effect of effect of LC n-3 PUFAs during dietary weight loss intervention on hunger hormone (Acylated Ghrelin).
  The measurements of Plasma Acylated Ghrelin concentrations will be determined using ELISA kit (Merck EMD Millipore, Millipore, Billerica, MO, USA).
  All analyses will be performed according to the manufacturer's protocol and instructions.
  measure: Cardiometabolic risk factor (Triglycerides)
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: Plasma concentration of Triglycerides levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).
  measure: Cardiometabolic risk factor (Insulin)
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: ELISA kits (Thermo Fischer, Vienna, Austria) will be used to measure concentrations of plasma insulin (Mercodia AB, Uppsala, Sweden).
  measure: Cardiometabolic risk factor (Glucose)
  time frame: 4 weeks, 12 weeks, and 20 weeks
  description: Glucose levels will be determined using an enzymatic hexokinase assay (Randox Laboratories Ltd., Crumlin, UK).
  HOMA-IR values will be calculated using the equation developed by Matthews and colleagues (Matthews, 1985).
  arm group label: Krill oil capsules (LC n-3 PUFAs)
  arm group type: Experimental
  description: 4 g/day krill oil (SuperbaBoostTM), with each 1g capsule containing 191mg EPA, 94mg DHA and 78mg choline.
  arm group label: Vegetable oil capsules
  arm group type: Placebo Comparator
  description: 4g/day of mixed vegetable oil (a mixture of olive oil (extra virgin, cold-pressed), maize oil (refined), palm kernel oil (refined) and medium-chain triglycerides, in the ratio 4:4:3:2).
  intervention type: Dietary Supplement
  intervention name: krill oil (SuperbaBoostTM)
  description: 4 g/day of Krill oil supplements (LC n-3 PUFAs) (1g capsule containing 191mg EPA, 94mg DHA and 78mg choline).
  arm group label: Krill oil capsules (LC n-3 PUFAs)
  intervention type: Dietary Supplement
  intervention name: 4g/day of mixed vegetable oil
  description: vegetable oil capsules (mixture of olive oil (extra virgin, cold-pressed), maize oil (refined), palm kernel oil (refined) and medium-chain triglycerides, in the ratio 4:4:3:2).
  arm group label: Vegetable oil capsules
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mansour Alblaji
  role: Principal Investigator
  affiliation: Human Nutrition School of Medicine, Dentistry and Nursing, University of Glasgow
  last name: Dalia Malkova, PhD
  phone: 07753433971
  email: Dalia.Malkova@glasgow.ac.uk
  last name: Mansour Alblaji
  phone: 07310647742
  email: m.alblaji.1@research.gla.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Glasgow
  investigator full name: Dr Dalia Malkova
  investigator title: Senior Lecturer Human Nutrition School of Medicine, Dentistry and Nursing College of Medical, Veterinary & Life Sciences University of Glasgow
  mesh term: Obesity
  mesh term: Overweight
  sharing ipd: No
  ipd description: The study will published in scientific journal upon finished