<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/NCT02252952</url>
  </required_header>
  <id_info>
    <org_study_id>1136635</org_study_id>
    <nct_id>NCT02252952</nct_id>
  </id_info>
  <brief_title>The Effect of Sugar Sweetened and Diet Beverages Consumed as Part of a Weight-Maintenance Diet on Fat Storage</brief_title>
  <official_title>A Comparison of the Effects of Sugar Sweetened Beverages (SSBs), Diet Beverages and Water on Weight, Body Composition, Liver and Muscle Fat Infiltration, Visceral Fat, Neurocognitive Function, Blood Lipids, Insulin Resistance and Hydration Status in Healthy Weight and Overweight, Premenopausal Females Aged 20-50</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rippe Lifestyle Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rippe Lifestyle Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of consumption of sugar sweetened and&#xD;
      diet beverages on overall fat mass and the fat mass of various tissues implicated in the&#xD;
      dysregulation of glucose metabolism. In addition, hypothalamic activity will also be&#xD;
      investigated after acute exposure to sugar sweetened and diet beverages, and again after 6&#xD;
      months of daily consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Excess fat deposition in skeletal muscle and the liver have both been implicated in the&#xD;
      metabolic dysregulation that leads to type II diabetes. It has been shown that daily&#xD;
      consumption of sugar sweetened beverages can lead to increases in the fat mass of these&#xD;
      organs. However, little appreciation was given for the effect of overall changes in weight&#xD;
      and fat mass or how applicable the doses provided may be for how sugar sweetened beverages&#xD;
      are typically consumed.&#xD;
&#xD;
      In addition, it has recently been shown that sugars can suppress hypothalamic activity and&#xD;
      alter patterns of brain connectivity in regions known to be involved in homeostasis and&#xD;
      reward aspects of food intake. However, these observations were made after large doses or&#xD;
      sugars not commonly consumed in isolation from other sugars or other macronutrients. Foods&#xD;
      containing non-caloric sweeteners have also been suggested to suppress hypothalamic activity&#xD;
      due to the disconnect between perceived sweetness and calories consumed.&#xD;
&#xD;
      AIM 1: To investigate the response to six months of daily consumption of sugar sweetened or&#xD;
      diet beverages as part of a weight-stable structured diet on whole body fat content, but also&#xD;
      specifically fat content of the liver, skeletal muscles the abdomen.&#xD;
&#xD;
      AIM 2: To investigate hypothalamic activity after acute exposure to sugar sweetened and or&#xD;
      diet beverages, and whether chronic exposure for 6 months induces any changes in hypothalamic&#xD;
      activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <primary_completion_date type="Anticipated">March 2015</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fat Storage</measure>
    <time_frame>Baseline and 6 Months</time_frame>
    <description>Changes in total body adiposity (body fat percentage and fat mass) as measured by Dual X Ray Absorbance after 6 months of daily consumption of sugar sweetened or diet beverages as part of a weight-maintenance structured diet. Changes in fat content of skeletal muscle (via MRI) and liver and the abdomen (both MRS) will also be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypothalamic Activity</measure>
    <time_frame>6 Months</time_frame>
    <description>Hypothalamic activity in response to consumption of sugar sweetened or diet beverages consumed as part of a standardized, mixed nutrient meal will be measured by functional MRI. Changes from baseline (mean percent signal change) will be determined after 6 months of daily consumption of the test beverage</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">99</enrollment>
  <condition>Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric Sweeteners</condition>
  <arm_group>
    <arm_group_label>Sugar Sweetened Beverages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Any beverage from a range of caffeine free, sugar sweetened drinks. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet Beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Any beverage from a range of caffeine free drinks sweetened with non-caloric sweetener. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 oz of water. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Beverage Consumption</intervention_name>
    <arm_group_label>Diet Beverage</arm_group_label>
    <arm_group_label>Sugar Sweetened Beverages</arm_group_label>
    <arm_group_label>Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  Age between 20-50 years&#xD;
&#xD;
          -  Body Mass Index (BMI) 21.0 to less than 30.0&#xD;
&#xD;
          -  Consumer of at least one sugar sweetened or diet beverage per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than a 3% change in weight within the 3 months prior to enrollment in the study.&#xD;
&#xD;
          -  Menstrual cycle that is not regular or post-menopausal&#xD;
&#xD;
          -  Continued consumption of a prescription medication for weight loss. If subject is&#xD;
             willing to discontinue prescription medication(s) immediately and willing to refrain&#xD;
             from taking medication(s) for duration of study, he/she may be enrolled after a&#xD;
             four-week washout period.&#xD;
&#xD;
          -  Continued consumption of over-the-counter weight loss supplement(s). If subject is&#xD;
             willing to discontinue supplement(s) immediately and willing to refrain from taking&#xD;
             supplement(s) for duration of study, he/she may be enrolled after a two-week washout&#xD;
             period.&#xD;
&#xD;
          -  Continued enrollment in commercial weight loss program (e.g. Jenny Craig, Weight&#xD;
             Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous). If subject is willing&#xD;
             to discontinue program immediately and willing to refrain from program for duration of&#xD;
             study, he/she may be included after a two-week washout period.&#xD;
&#xD;
          -  History of thyroid disease, but not taking medication or medication dosage changed one&#xD;
             or more times over last 6 months. History of thyroid disease and on a stable dose of&#xD;
             prescription medication for 6 months or longer is acceptable.&#xD;
&#xD;
          -  Diagnosed with Type I or Type II diabetes or prediabetes.&#xD;
&#xD;
          -  History of major surgery within three months of enrollment.&#xD;
&#xD;
          -  History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months&#xD;
             prior to enrollment.&#xD;
&#xD;
          -  Presence of implanted cardiac defibrillator or pacemaker.&#xD;
&#xD;
          -  Hypertension/high blood pressure, or any hypertensive medication.&#xD;
&#xD;
          -  History of a surgical procedure for weight loss at any time (e.g. gastroplasty,&#xD;
             gastric by-pass, gastrectomy or partial gastrectomy).&#xD;
&#xD;
          -  Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer&#xD;
             disease, Crohn's disease, chronic diarrhea or active gallbladder disease.&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  History of fatty liver&#xD;
&#xD;
          -  History or presence of cancer. Persons with successfully resected basal cell carcinoma&#xD;
             of the skin may be enrolled if treatment completed more than 6 months prior to&#xD;
             enrollment.&#xD;
&#xD;
          -  History of clinically diagnosed eating disorders including anorexia nervosa, bulimia&#xD;
             nervosa or binge eating disorder.&#xD;
&#xD;
          -  Women who are pregnant, lactating or trying to become pregnant.&#xD;
&#xD;
          -  Any change in prescription medication within 3 months prior to enrollment&#xD;
&#xD;
          -  Currently consuming &gt;14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5&#xD;
             fl oz liquor) per week.&#xD;
&#xD;
          -  Known allergy to high fructose corn syrup, sucrose, fructose or glucose.&#xD;
&#xD;
          -  History of alcohol dependency&#xD;
&#xD;
          -  Extreme exercise regimes (eg. Marathon or triathlon)&#xD;
&#xD;
          -  Currently smoking cigarettes&#xD;
&#xD;
          -  Any clinically significant food allergy&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days prior to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James M Rippe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rippe Lifestyle Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rippe Lifestyle Institute</name>
      <address>
        <city>Celebration</city>
        <state>Florida</state>
        <zip>34747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>December 15, 2014</last_update_submitted>
  <last_update_submitted_qc>December 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sugar Sweetened Beverages, Diet Beverages, ectopic fat, Functional MRI</keyword>
  <!-- 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/NCT02252952
org study id: 1136635
nct id: NCT02252952
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the effects of consumption of sugar sweetened and
      diet beverages on overall fat mass and the fat mass of various tissues implicated in the
      dysregulation of glucose metabolism. In addition, hypothalamic activity will also be
      investigated after acute exposure to sugar sweetened and diet beverages, and again after 6
      months of daily consumption.
Excess fat deposition in skeletal muscle and the liver have both been implicated in the
      metabolic dysregulation that leads to type II diabetes. It has been shown that daily
      consumption of sugar sweetened beverages can lead to increases in the fat mass of these
      organs. However, little appreciation was given for the effect of overall changes in weight
      and fat mass or how applicable the doses provided may be for how sugar sweetened beverages
      are typically consumed.

      In addition, it has recently been shown that sugars can suppress hypothalamic activity and
      alter patterns of brain connectivity in regions known to be involved in homeostasis and
      reward aspects of food intake. However, these observations were made after large doses or
      sugars not commonly consumed in isolation from other sugars or other macronutrients. Foods
      containing non-caloric sweeteners have also been suggested to suppress hypothalamic activity
      due to the disconnect between perceived sweetness and calories consumed.

      AIM 1: To investigate the response to six months of daily consumption of sugar sweetened or
      diet beverages as part of a weight-stable structured diet on whole body fat content, but also
      specifically fat content of the liver, skeletal muscles the abdomen.

      AIM 2: To investigate hypothalamic activity after acute exposure to sugar sweetened and or
      diet beverages, and whether chronic exposure for 6 months induces any changes in hypothalamic
      activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Fat Storage
time frame: Baseline and 6 Months
description: Changes in total body adiposity (body fat percentage and fat mass) as measured by Dual X Ray Absorbance after 6 months of daily consumption of sugar sweetened or diet beverages as part of a weight-maintenance structured diet. Changes in fat content of skeletal muscle (via MRI) and liver and the abdomen (both MRS) will also be assessed.
measure: Hypothalamic Activity
time frame: 6 Months
description: Hypothalamic activity in response to consumption of sugar sweetened or diet beverages consumed as part of a standardized, mixed nutrient meal will be measured by functional MRI. Changes from baseline (mean percent signal change) will be determined after 6 months of daily consumption of the test beverage
arm group label: Sugar Sweetened Beverages
arm group type: Experimental
description: Any beverage from a range of caffeine free, sugar sweetened drinks. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.
arm group label: Diet Beverage
arm group type: Experimental
description: Any beverage from a range of caffeine free drinks sweetened with non-caloric sweetener. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.
arm group label: Water
arm group type: Active Comparator
description: 12 oz of water. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.
intervention type: Other
intervention name: Beverage Consumption
arm group label: Diet Beverage
arm group label: Sugar Sweetened Beverages
arm group label: Water
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James M Rippe, MD
role: Principal Investigator
affiliation: Rippe Lifestyle Institute
facility: 
country: United States
responsible party type: Sponsor