Fructose and (Aging) (FRUage)
Investigation of the Effect of Fructose on Health Parameters and the Intestinal Barrier in Healthy Individuals
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ina Bergheim, Prof.
- Phone Number: +43-1-4277-54981
- Email: ina.bergheim@univie.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- University of Vienna
-
Contact:
- Ina Bergheim, Prof.
- Phone Number: +43-1-4277-54981
- Email: ina.bergheim@univie.ac.at
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- all gender, healthy collective ≥ 18 years old
Exclusion Criteria:
- Chronic inflammatory diseases of the gastrointestinal tract
- Metabolic diseases or taking medication to treat metabolic diseases
- Fructose malabsorption
- Hereditary fructose intolerance
- Food intolerances and/or allergies, as well as food allergies that require special dietary interventions
- Special diets, such as vegetarian/vegan diets
- Unstable body weight within the last 6 months (fluctuations of > 5%)
- BMI < 19 kg/m2 & > 29,9 kg/m2
- Bariatric surgery
- Smoking
- Liver diseases
- Renal insufficiency
- Rheumatoid arthritis
- COPD with ≥ 2 exacerbations per year
- Chronic pancreatitis or recurrent acute pancreatitis
- Alcohol consumption above 10 g/d for women and above 20 g/d for men
- Pregnancy and breastfeeding
- Viral or bacterial infections that occurred no longer than 3 weeks ago
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Fructose
Following a standardization of their nutritional intake for three days, participants will receive a drink supplemented with free fructose.
|
Following a standardization of their nutritional intake for three days, participants will either receive a drink supplemented with low doses of free fructose (5%).
Other Names:
|
|
Experimental: Glucose
Following a standardization of their nutritional intake for three days, participants will receive a drink supplemented with free glucose.
|
Following a standardization of their nutritional intake for three days, participants will either receive a drink supplemented with low doses of free glucose (5 %).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in markers of intestinal permeability
Time Frame: At the end of the treatment (1 month)
|
Changes in concentrations of bacterial endotoxin in blood plasma
|
At the end of the treatment (1 month)
|
|
Cytokine release from blood immune cells stimulated with bacterial toxins
Time Frame: At the end of the treatment (1 month)
|
Changes in cytokine concentration in supernatant of immune cells before and after the treatments
|
At the end of the treatment (1 month)
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- UVienna25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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