NCT05717595

Brief Summary

To investigate whether changes in fructose dietary intake can help to improve dietary fructose-induced insulin resistance and post bariatric weight loss in obese subjects of Caucasian descent

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

February 5, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 8, 2023

Last Update Submit

January 29, 2023

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • oral fructose handling

    to correlate changes in oral fructose excursions (measured by AUC of fructose tolerance test enriched with 13C6-labeled fructose with glucose excursions (MAGE by Freestyle Libre)

    4 weeks

Secondary Outcomes (4)

  • fructose changes in visceral organs

    4 weeks up to one year

  • gutmicrobiota

    4 weeks up to one year

  • metabolites

    4 weeks up to one year

  • weight

    4 weeks up to one year

Study Arms (2)

high fructose

OTHER

high fructose (\>100 gram fructose / day) for 4 weeks

Dietary Supplement: fructose

low fructose

OTHER

low fructose diet (\<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks

Dietary Supplement: fructose

Interventions

fructoseDIETARY_SUPPLEMENT

oral ingestion of fructose vs dextrose

Also known as: dextrose
high fructoselow fructose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for a RYGB gastric bypass\*
  • Men and premenopausal women \> 18 years of age
  • Caucasian descent
  • Ability to provide written informed consent
  • \* All subjects on the waiting list meet the criteria for bariatric surgery, that is:
  • BMI \> 40 kg/m2 OR \>35 kg/m2 with obesity related co-morbidity
  • Reasonable supervised attempts to lose weight

You may not qualify if:

  • Unstable metabolic condition defined as;
  • Diabetes with poor glycemic control (HbA1c \> 8.5%);
  • Use of an antidiabetic or anti-obesity drug;
  • Malabsorptive or restrictive bariatric (weight loss) surgery in history
  • Evidence for a form of liver disease (except for NAFLD without cirrhosis)
  • Known genetic basis for insulin resistance or glucose intolerance
  • Use of certain drugs known to produce hepatic steatosis in the previous 6 months (such as oral corticosteroids, high-dose estrogens, methotrexate, tetracycline, amiodarone)
  • Malabsorptive disease orders (celiac disease, inflammatory bowel disease)
  • Use of certain drugs that may injure the lining of the intestine in the previous months (colchicine, cholestyramine)
  • Excessive alcohol intake (≥5 IU per day or ≥ 14 IU per week)
  • Recent use of antibiotics (≤ 3 months before surgery)
  • Hemostasis disorders or current treatment with anticoagulants Any primary lipid disorder
  • Unable to maintain diet intervention, or unable to reliably rapport diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC location AMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

FructoseGlucose

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Central Study Contacts

daniko sindhunata, MD

CONTACT

0031 20 5669111d.p.sindhunata@amsterdamumc.nl

max nieuwdorp, MD PhD

CONTACT

003120 5669111m.nieuwdorp@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
randomisation
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: randomized double blinded trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 8, 2023

First Posted

February 8, 2023

Study Start

February 5, 2023

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

not allowed due to GDPR in Netherlands

Locations

NL(1)