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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Diet

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 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.

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Investigators: Principal Investigator: Stephan C Bischoff, University of Hohenheim

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2009
• Primary Completion (Actual): October 15, 2009
• Study Completion (Actual): October 15, 2009

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 16, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Fructose Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No