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Completed

NCT Number: NCT03444233

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Body Weight Digestive System Diseases Fatty Liver Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Diet

Other

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

Other names: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld

Primary outcomes

  1. 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

  1. fatty liver index

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

    Change in fatty liver index after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  2. Non-alcoholic fatty liver disease (NAFLD)

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

    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.

  3. Body weight

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

    Change from baseline in body weight after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  4. Blood pressure (systolic and diastolic)

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

    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.

  5. GGT

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

    Change in GGT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  6. GOT

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

    Change in GOT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  7. GPT

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

    Change in GPT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  8. AP

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

    Change in AP after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  9. Triglycerides

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

    Change in triglycerides after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  10. HDL

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

    Change in HDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  11. LDL

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

    Change in LDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  12. Fasting glucose

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

    Change in fasting glucose after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  13. BSR

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

    Change in BSR after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  14. Kreatinine

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

    Change in Kreatinine after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  15. Uric acid

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

    Change in uric acid after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  16. Urea

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

    Change in urea after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  17. Cholesterol

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

    Change in cholesterol after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  18. Ghrelin

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

    Change in ghrelin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

  19. Leptin

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

    Change in leptin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2018
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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