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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444233
• Other study ID #: Fructose Study
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2018
• Last updated: February 16, 2018
• Start date: August 15, 2009
• Est. completion date: October 15, 2009

Study information

• Verified date: February 2018
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 15, 2009
• Est. primary completion date: October 15, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

Other:
• Diet
7 days fruit-rich diet, 7 days HFCS-rich diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.