Comparing the effect of a high SFA diet and high fructose diet on hepatic insulin sensitivity

Completed

• Conditions: decreased insulin sensitivity; Insulin resistance; 10019654; 10018424

• Registration Number: NL-OMON54415
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

- Participants are able to provide signed and dated written informed consent
prior to any study specific procedures
- Participants should have suitable veins for cannulation or repeated
venipuncture
- Women are post-menopausal (defined as at least 1 year post cessation of
menses)
- Aged >= 45 and <= 75 years
- Body mass index (BMI) 27 - 38 kg/m2
- Stable dietary habits (no weight loss or gain >5kg in the past 3 months)
- Sedentary lifestyle (not more than 2 hours of sports per week)
- No signs of active cardiovascular disease, liver or kidney malfunction
- Liver fat content >= 2% weight/weight.

Exclusion Criteria

- Type 2 diabetes
- Previous enrolment in a clinical study with an investigational product during
the last 3 months or as judged by the Investigator
- Patients with congestive heart failure and and/or severe renal and or liver
insufficiency or another condition that may interfere with outcomes measured in
this study
- Any contra-indication MRI scanning
- Alcohol consumption of >2 servings per day for men and >1 servings per day
for woman
- Smoking in the past 6 months
- Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l
- Vegetarian, vegan, food intolerant to common foods (e.g. gluten
intolerant, lactose intolerant)
- Medication use that may influence outcome parameters

A medical doctor will judge participation eligibility based on the medical
history questionnaire, medication use and fasting blood parameters. If the
medical doctor advises that a volunteer cannot participate, the volunteer will
be excluded from enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is hepatic insulin sensitivity (suppression of EGP during<br /><br>clamp) upon a 4-week high SFA diet versus a 4-week fructose diet. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are:<br /><br>- de novo lipogenesis upon 4-week high SFA versus 4-week high fructose diet<br /><br>- change in (baseline-end intervention) hepatic SFA fraction upon 4-week high<br /><br>SFA versus 4-week high fructose.</p><br>