Clinical trial NCT03444233: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Alcoholic Fatty Liver Disease
Obesity
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 12
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: metabolite concentration
timeFrame: Participants will be followed for the time of four weeks.
Secondary outcomes:
measure: fatty liver index
timeFrame: Participants will be followed for the time of four weeks.
measure: Non-alcoholic fatty liver disease (NAFLD)
timeFrame: Participants will be followed for the time of four weeks.
measure: Body weight
timeFrame: Participants will be followed for the time of four weeks.
measure: Blood pressure (systolic and diastolic)
timeFrame: Participants will be followed for the time of four weeks.
measure: GGT
timeFrame: Participants will be followed for the time of four weeks.
measure: GOT
timeFrame: Participants will be followed for the time of four weeks.
measure: GPT
timeFrame: Participants will be followed for the time of four weeks.
measure: AP
timeFrame: Participants will be followed for the time of four weeks.
measure: Triglycerides
timeFrame: Participants will be followed for the time of four weeks.
measure: HDL
timeFrame: Participants will be followed for the time of four weeks.
measure: LDL
timeFrame: Participants will be followed for the time of four weeks.
measure: Fasting glucose
timeFrame: Participants will be followed for the time of four weeks.
measure: BSR
timeFrame: Participants will be followed for the time of four weeks.
measure: Kreatinine
timeFrame: Participants will be followed for the time of four weeks.
measure: Uric acid
timeFrame: Participants will be followed for the time of four weeks.
measure: Urea
timeFrame: Participants will be followed for the time of four weeks.
measure: Cholesterol
timeFrame: Participants will be followed for the time of four weeks.
measure: Ghrelin
timeFrame: Participants will be followed for the time of four weeks.
measure: Leptin
timeFrame: Participants will be followed for the time of four weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of Hohenheim
name: Stephan C Bischoff
role: PRINCIPAL_INVESTIGATOR
References: