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

Study Overview
=================
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.

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

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease, Obesity

Intervention / Treatment
-----------------
* Other: Diet


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low f1 diet<br>low fructose diet week 1 | Other: Diet<br>* 7 days fruit-rich diet, 7 days HFCS-rich diet<br>* Other names: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld;|
| Experimental: fruit rich diet<br>fruit rich diet week 2 | Other: Diet<br>* 7 days fruit-rich diet, 7 days HFCS-rich diet<br>* Other names: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld;|
| Experimental: low f2 diet<br>low fructose diet week 3 | Other: Diet<br>* 7 days fruit-rich diet, 7 days HFCS-rich diet<br>* Other names: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld;|
| Experimental: HFCS rich diet<br>HFCS rich diet week 4 | Other: Diet<br>* 7 days fruit-rich diet, 7 days HFCS-rich diet<br>* Other names: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants will be followed for the time of four weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Participants will be followed for the time of four weeks. |