A Phase 4 interventional study of Diet in Non-Alcoholic Fatty Liver Disease and Obesity, sponsored by University of Hohenheim. Completed. Open to female participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by University of Hohenheim · Phase 4, Interventional, and Prevention
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.
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:
low fructose diet week 1
Other: Diet
fruit rich diet week 2
Other: Diet
low fructose diet week 3
Other: Diet
HFCS rich diet week 4
Other: Diet
7 days fruit-rich diet, 7 days HFCS-rich diet
Also known as: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld
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.
Time frame: Participants will be followed for the time of four weeks.
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.
Time frame: Participants will be followed for the time of four weeks.
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.
Time frame: Participants will be followed for the time of four weeks.
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.
Time frame: Participants will be followed for the time of four weeks.
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.
Time frame: Participants will be followed for the time of four weeks.
GGT
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.
GOT
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.
GPT
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.
AP
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.
Triglycerides
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.
HDL
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.
LDL
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.
Fasting glucose
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.
BSR
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.
Kreatinine
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.
Uric acid
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.
Urea
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.
Cholesterol
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.
Ghrelin
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.
Leptin
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.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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University of Hohenheim