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Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Obesity

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Diet
Sponsored by
University of Hohenheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

20 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults, aged between 20 and 30 years
  • normal weighted (BMI ≤ 25 kg/m2) and obese (BMI 35-50 kg/m2)
  • written informed consent

At initial medical examination an anamnesis, physical examination, blood sample collection (10 ml) was performed to check for eligibility. Furthermore, a hydrogen breath test was performed to detect potential fructose intolerance

Exclusion Criteria:

  • smoking,
  • fructose intolerance/ -malabsorption,
  • pregnancy
  • chronic gastrointestinal diseases (e.g. chronic inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.),
  • operation on the gastrointestinal tract (exclusively appendectomy)
  • anemia,
  • hepatic or renal disease
  • diabetes mellitus
  • consuming illnesses (e.g. cancer, acquired immunodeficiency syndrome (AIDS)) - drug intake affecting lipid or glucose metabolism (cholesterol- or glucose reducing or antihypertensive drugs, steroids, L-Thyroxin, antidepressants, weight reducing drugs).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    low f1 diet

    fruit rich diet

    low f2 diet

    HFCS rich diet

    Arm Description

    low fructose diet week 1

    fruit rich diet week 2

    low fructose diet week 3

    HFCS rich diet week 4

    Outcomes

    Primary Outcome Measures

    metabolite concentration
    The primary endpoint is the change of metabolite concentration after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

    Secondary Outcome Measures

    fatty liver index
    Change in fatty liver index after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Non-alcoholic fatty liver disease (NAFLD)
    Change in the classification of non-alcoholic fatty liver disease (NAFLD) based on ultrasound after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Body weight
    Change from baseline in body weight after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Blood pressure (systolic and diastolic)
    Change in blood pressure (systolic and diastolic) after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    GGT
    Change in GGT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    GOT
    Change in GOT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    GPT
    Change in GPT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    AP
    Change in AP after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Triglycerides
    Change in triglycerides after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    HDL
    Change in HDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    LDL
    Change in LDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Fasting glucose
    Change in fasting glucose after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    BSR
    Change in BSR after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Kreatinine
    Change in Kreatinine after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Uric acid
    Change in uric acid after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Urea
    Change in urea after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Cholesterol
    Change in cholesterol after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Ghrelin
    Change in ghrelin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Leptin
    Change in leptin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

    Full Information

    First Posted
    February 16, 2018
    Last Updated
    February 16, 2018
    Sponsor
    University of Hohenheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03444233
    Brief Title
    Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.
    Official Title
    Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 15, 2009 (Actual)
    Primary Completion Date
    October 15, 2009 (Actual)
    Study Completion Date
    October 15, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Hohenheim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate how a high-fructose diet, either by high fructose intake from complex, natural foods or by fortifying the diet with corn syrup, affects the metabolism. Furthermore, it will be investigate if there are differences between obese and normal weight participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Alcoholic Fatty Liver Disease, Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    low f1 diet
    Arm Type
    Experimental
    Arm Description
    low fructose diet week 1
    Arm Title
    fruit rich diet
    Arm Type
    Experimental
    Arm Description
    fruit rich diet week 2
    Arm Title
    low f2 diet
    Arm Type
    Experimental
    Arm Description
    low fructose diet week 3
    Arm Title
    HFCS rich diet
    Arm Type
    Experimental
    Arm Description
    HFCS rich diet week 4
    Intervention Type
    Other
    Intervention Name(s)
    Diet
    Other Intervention Name(s)
    C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld
    Intervention Description
    7 days fruit-rich diet, 7 days HFCS-rich diet
    Primary Outcome Measure Information:
    Title
    metabolite concentration
    Description
    The primary endpoint is the change of metabolite concentration after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Secondary Outcome Measure Information:
    Title
    fatty liver index
    Description
    Change in fatty liver index after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Non-alcoholic fatty liver disease (NAFLD)
    Description
    Change in the classification of non-alcoholic fatty liver disease (NAFLD) based on ultrasound after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Body weight
    Description
    Change from baseline in body weight after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Blood pressure (systolic and diastolic)
    Description
    Change in blood pressure (systolic and diastolic) after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    GGT
    Description
    Change in GGT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    GOT
    Description
    Change in GOT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    GPT
    Description
    Change in GPT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    AP
    Description
    Change in AP after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Triglycerides
    Description
    Change in triglycerides after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    HDL
    Description
    Change in HDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    LDL
    Description
    Change in LDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Fasting glucose
    Description
    Change in fasting glucose after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    BSR
    Description
    Change in BSR after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Kreatinine
    Description
    Change in Kreatinine after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Uric acid
    Description
    Change in uric acid after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Urea
    Description
    Change in urea after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Cholesterol
    Description
    Change in cholesterol after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Ghrelin
    Description
    Change in ghrelin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.
    Title
    Leptin
    Description
    Change in leptin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
    Time Frame
    Participants will be followed for the time of four weeks.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adults, aged between 20 and 30 years normal weighted (BMI ≤ 25 kg/m2) and obese (BMI 35-50 kg/m2) written informed consent At initial medical examination an anamnesis, physical examination, blood sample collection (10 ml) was performed to check for eligibility. Furthermore, a hydrogen breath test was performed to detect potential fructose intolerance Exclusion Criteria: smoking, fructose intolerance/ -malabsorption, pregnancy chronic gastrointestinal diseases (e.g. chronic inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.), operation on the gastrointestinal tract (exclusively appendectomy) anemia, hepatic or renal disease diabetes mellitus consuming illnesses (e.g. cancer, acquired immunodeficiency syndrome (AIDS)) - drug intake affecting lipid or glucose metabolism (cholesterol- or glucose reducing or antihypertensive drugs, steroids, L-Thyroxin, antidepressants, weight reducing drugs).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephan C Bischoff
    Organizational Affiliation
    University of Hohenheim
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.

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