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

University of Hohenheim

Status and phase: Completed; Phase 4

Conditions: Obesity; Non-Alcoholic Fatty Liver Disease

Treatments: Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03444233

Fructose Study

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

low f1 diet

Experimental group

Description:

low fructose diet week 1

Treatment:

Other: Diet

fruit rich diet

Experimental group

Description:

fruit rich diet week 2

Treatment:

Other: Diet

low f2 diet

Experimental group

Description:

low fructose diet week 3

Treatment:

Other: Diet

HFCS rich diet

Experimental group

Description:

HFCS rich diet week 4

Treatment:

Other: Diet