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Clinical Trials/NCT03444233
NCT03444233CompletedPhase 4

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

University of Hohenheim0 sites12 target enrollmentStarted: August 15, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
12
Primary Endpoint
metabolite concentration
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to 30 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

  • •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)
  • •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).

Arms & Interventions

low f1 diet

Experimental

low fructose diet week 1

Intervention: Diet (Other)

fruit rich diet

Experimental

fruit rich diet week 2

Intervention: Diet (Other)

low f2 diet

Experimental

low fructose diet week 3

Intervention: Diet (Other)

HFCS rich diet

Experimental

HFCS rich diet week 4

Intervention: Diet (Other)

Outcomes

Primary Outcomes

metabolite concentration

Time Frame: Participants will be followed for the time of four weeks.

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.

Secondary Outcomes

  • fatty liver index(Participants will be followed for the time of four weeks.)
  • Non-alcoholic fatty liver disease (NAFLD)(Participants will be followed for the time of four weeks.)
  • Body weight(Participants will be followed for the time of four weeks.)
  • Urea(Participants will be followed for the time of four weeks.)
  • Cholesterol(Participants will be followed for the time of four weeks.)
  • Ghrelin(Participants will be followed for the time of four weeks.)
  • Leptin(Participants will be followed for the time of four weeks.)
  • Blood pressure (systolic and diastolic)(Participants will be followed for the time of four weeks.)
  • GGT(Participants will be followed for the time of four weeks.)
  • GOT(Participants will be followed for the time of four weeks.)
  • GPT(Participants will be followed for the time of four weeks.)
  • AP(Participants will be followed for the time of four weeks.)
  • Triglycerides(Participants will be followed for the time of four weeks.)
  • HDL(Participants will be followed for the time of four weeks.)
  • LDL(Participants will be followed for the time of four weeks.)
  • Fasting glucose(Participants will be followed for the time of four weeks.)
  • BSR(Participants will be followed for the time of four weeks.)
  • Kreatinine(Participants will be followed for the time of four weeks.)
  • Uric acid(Participants will be followed for the time of four weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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