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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54415
Enrollment
24
Registered
2021-10-13
Start date
2021-11-08
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

decreased insulin sensitivity Insulin resistance

Interventions

Participants follow a 4-week high SFA diet and a 4-week high fructose diet. Examples of products included in the high SFA diet include: Red meat, mature 48+ cheese, butter, all-butter biscuits, full-

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome is hepatic insulin sensitivity (suppression of EGP during clamp) upon a 4-week high SFA diet versus a 4-week fructose diet.

Secondary

MeasureTime frame
Secondary outcomes are: - de novo lipogenesis upon 4-week high SFA versus 4-week high fructose diet - change in (baseline-end intervention) hepatic SFA fraction upon 4-week high SFA versus 4-week high fructose.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)