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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444233
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of Hohenheim

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Obesity Other: Diet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.
Actual Study Start Date : August 15, 2009
Actual Primary Completion Date : October 15, 2009
Actual Study Completion Date : October 15, 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Arm Intervention/treatment
Experimental: low f1 diet
low fructose diet week 1
Other: Diet
7 days fruit-rich diet, 7 days HFCS-rich diet
Other Name: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld

Experimental: fruit rich diet
fruit rich diet week 2
Other: Diet
7 days fruit-rich diet, 7 days HFCS-rich diet
Other Name: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld

Experimental: low f2 diet
low fructose diet week 3
Other: Diet
7 days fruit-rich diet, 7 days HFCS-rich diet
Other Name: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld

Experimental: HFCS rich diet
HFCS rich diet week 4
Other: Diet
7 days fruit-rich diet, 7 days HFCS-rich diet
Other Name: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld




Primary Outcome Measures :
  1. metabolite concentration [ Time Frame: Participants will be followed for the time of four weeks. ]
    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 :
  1. fatty liver index [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in fatty liver index after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  2. Non-alcoholic fatty liver disease (NAFLD) [ Time Frame: Participants will be followed for the time of four weeks. ]
    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.

  3. Body weight [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change from baseline in body weight after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  4. Blood pressure (systolic and diastolic) [ Time Frame: Participants will be followed for the time of four weeks. ]
    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.

  5. GGT [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in GGT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  6. GOT [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in GOT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  7. GPT [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in GPT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  8. AP [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in AP after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  9. Triglycerides [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in triglycerides after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  10. HDL [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in HDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  11. LDL [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in LDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  12. Fasting glucose [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in fasting glucose after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  13. BSR [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in BSR after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  14. Kreatinine [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in Kreatinine after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  15. Uric acid [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in uric acid after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  16. Urea [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in urea after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  17. Cholesterol [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in cholesterol after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  18. Ghrelin [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in ghrelin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  19. Leptin [ Time Frame: Participants will be followed for the time of four weeks. ]
    Change in leptin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444233


Sponsors and Collaborators
University of Hohenheim
Investigators
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Principal Investigator: Stephan C Bischoff University of Hohenheim

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Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT03444233    
Other Study ID Numbers: Fructose Study
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases