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

NCT ID: NCT03444233

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-15
• Study Completion Date: 2009-10-15

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

low f1 diet

low fructose diet week 1

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

7 days fruit-rich diet, 7 days HFCS-rich diet

fruit rich diet

fruit rich diet week 2

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

7 days fruit-rich diet, 7 days HFCS-rich diet

low f2 diet

low fructose diet week 3

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

7 days fruit-rich diet, 7 days HFCS-rich diet

HFCS rich diet

HFCS rich diet week 4

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

7 days fruit-rich diet, 7 days HFCS-rich diet

Interventions

Diet

7 days fruit-rich diet, 7 days HFCS-rich diet

Intervention Type: OTHER

Other Intervention Names

C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hohenheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan C Bischoff

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim

Other Identifiers

Fructose Study

Identifier Type: -

Identifier Source: org_study_id