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

NCT03444233 | Completed Phase 4

• 1 other identifier: Fructose Study
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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.

• 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.

Study Arms (4)

low f1 diet

EXPERIMENTAL

low fructose diet week 1

Other: Diet

fruit rich diet

EXPERIMENTAL

fruit rich diet week 2

Other: Diet

low f2 diet

EXPERIMENTAL

low fructose diet week 3

Other: Diet

HFCS rich diet

EXPERIMENTAL

HFCS rich diet week 4

Other: Diet

Interventions

Diet OTHER

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

Also known as: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld

HFCS rich diet; fruit rich diet; low f1 diet; low f2 diet

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Hohenheim: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Stephan C Bischoff

  University of Hohenheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 23, 2018
• Study Start: August 15, 2009
• Primary Completion: October 15, 2009
• Study Completion: October 15, 2009
• Last Updated: February 23, 2018

Record last verified: 2018-02