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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03444233
Other study ID # Fructose Study
Secondary ID
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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.
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