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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03444233

Enrollment

Registered

2018-02-23

Start date

2009-08-15

Completion date

2009-10-15

Last updated

2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease, Obesity

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.

Interventions

OTHERDiet

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 30 Years

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

* 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).

Design outcomes

Primary

Measure	Time frame	Description
metabolite concentration	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

Measure	Time frame	Description
Non-alcoholic fatty liver disease (NAFLD)	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.
Body weight	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.
Blood pressure (systolic and diastolic)	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.
GGT	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.
GOT	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.
GPT	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.
AP	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.
Triglycerides	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.
HDL	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.
fatty liver index	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.
Fasting glucose	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.
BSR	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.
Kreatinine	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.
Uric acid	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.
Urea	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.
Cholesterol	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.
Ghrelin	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.
Leptin	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.
LDL	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026