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

Phase 4
Completed
Conditions
Non-Alcoholic Fatty Liver Disease
Obesity
Interventions
Other: Diet
Registration Number
NCT03444233
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
12
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
low f2 dietDietlow fructose diet week 3
HFCS rich dietDietHFCS rich diet week 4
low f1 dietDietlow fructose diet week 1
fruit rich dietDietfruit rich diet week 2
Primary Outcome Measures
NameTimeMethod
metabolite concentrationParticipants 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
NameTimeMethod
fatty liver indexParticipants 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.

Non-alcoholic fatty liver disease (NAFLD)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.

Body weightParticipants 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.

Blood pressure (systolic and diastolic)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.

GGTParticipants 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.

GOTParticipants 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.

GPTParticipants 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.

APParticipants 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.

TriglyceridesParticipants 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.

HDLParticipants 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.

LDLParticipants 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.

Fasting glucoseParticipants 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.

BSRParticipants 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.

KreatinineParticipants 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.

Uric acidParticipants 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.

UreaParticipants 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.

CholesterolParticipants 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.

GhrelinParticipants 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.

LeptinParticipants 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.

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