Insulin ResistanceNCT05017675
Effect of Dietary SFA and Fructose on Hepatic Insulin Sensitivity
A study testing High fructose diet and High saturated fat diet in people with Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
High rates of de novo lipogenesis (DNL) and high saturated fatty acid (SFA) fraction in the liver both have been associated with poor metabolic health and hepatic insulin resistance. Interestingly, the end product of DNL is mainly SFA. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- High fructose diet and High saturated fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Nov 2021to 24 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 ER
About this study
Official title: Comparing the Effect of a High SFA Diet and High Fructose Diet on Hepatic Insulin Sensitivity
High rates of de novo lipogenesis (DNL) and high saturated fatty acid (SFA) fraction in the liver both have been associated with poor metabolic health and hepatic insulin resistance. Interestingly, the end product of DNL is mainly SFA. So far it is unknown whether it is the process of DNL or the accumulation of SFA per se that leads to hepatic insulin resistance. Therefore, it is of interest to compare the effect of a diet that modifies directly hepatic SFA content (4-week high SFA diet) and a diet that changes SFA indirectly by modifying rates of DNL (4-week high fructose diet). To this end, 18 overweight/obese, but otherwise healthy, males and females will take part in the randomized dietary interventions. 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.
Read the detailed description
Rationale: High rates of de novo lipogenesis (DNL) and high saturated fatty acid (SFA) fraction in the liver both have been associated with poor metabolic health and hepatic insulin resistance. Interestingly, the end product of DNL is mainly SFA. So far it is unknown whether it is the process of DNL or the accumulation of SFA per se that leads to hepatic insulin resistance. This is a clinically relevant question, as it will give novel insights towards the best strategy for prevention and treatment of hepatic insulin resistance. Therefore, it is of interest to compare the effect of a diet that modifies directly hepatic SFA content (high SFA diet) and a diet that changes SFA indirectly by modifying rates of DNL (high fructose diet).
Objective: To determine the effect of a 4-week high SFA diet compared to a 4-week high fructose diet on hepatic insulin sensitivity, on hepatic SFA fraction and DNL.
Study design: This is a randomized intervention study comparing the effects of a 4-week high SFA diet compared to a 4-week high fructose diet on hepatic insulin sensitivity.
Study population: 24 overweight/obese, but otherwise healthy, males and females (BMI 27-38 kg/m2), 45-75 years, will participate in the study. Of these 24 included participants, 18 are expected to meet the study criteria and take part in the measurements following the screening, of these 14 need to complete the study.
Intervention: Participants follow a 4-week high SFA diet and a 4-week high fructose diet.
Main study parameters/endpoints: 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 outcomes are DNL upon 4-week high SFA versus 4-week high fructose, and delta (baseline-end intervention) hepatic SFA fraction upon 4-week high SFA versus 4-week high fructose.
- Conditions
- Insulin Resistance
- Being tested
- High fructose diet, High saturated fat diet
- Keywords
- High fructose diet, High saturated fat diet, De novo lipogenesis, Hepatic saturated fatty acids
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fructose dietOther
4 week high fructose diet.
Intended composition (En%):
Carbohydrates: 60-70 Fat: 20-30 Protein: 10-15 Fructose: 20 SFA: 5
High saturated fat dietOther
4 week high saturated fat diet.
Intended composition (En%):
Carbohydrates: 35-45 Fat: 40-50 Protein: 10-15 Fructose: 5 SFA: 20
| Study group | Role | What they receive |
|---|---|---|
| High fructose diet | Experimental | Participants will receive dietary products high in fructose for 4 weeks. Receives: Other: High fructose diet |
| High saturated fat diet | Experimental | Participants will receive dietary products high in saturated fat for 4 weeks. Receives: Other: High saturated fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic insulin sensitivity measured by hyperinsulinemic-euglycemic clamp.
difference in EGP suppression after the high SFA diet and the high fructose diet
Measured: after 28 days of each diet
Secondary outcomes (2)
Hepatic fat composition measured by proton magnetic resonance spectroscopy
The change in liver fat composition (%SFA, %MUFA and %PUFA) after the high SFA diet and the high fructose diet
Measured: first day of each diet - after 28 days of each diet
De novo lipogenesis measured by deuterated water
Difference between overnight DNL after the high SFA diet and the high fructose diet. Measured as relative contribution of newly synthesized palmitate in the VLDL-TG pool expressed as %DNL.
Measured: after 25 days of each diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start8 Nov 2021
- Primary completion19 Apr 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Schrauwen-Hinderling, Dr, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017675
- Sponsor's protocol ID
- NL78281.068.21
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be obtained with the principal investigator if desired.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of a High SFA Diet and High Fructose Diet on Hepatic Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT05017675
- Acronym / sponsor ID
- NL78281.068.21
- Conditions
- Insulin Resistance
- Keywords
- High fructose diet, High saturated fat diet, De novo lipogenesis, Hepatic saturated fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High rates of de novo lipogenesis (DNL) and high saturated fatty acid (SFA) fraction in the liver both have been associated with poor metabolic health and hepatic insulin resistance. Interestingly, the end product of DNL is mainly SFA. So far it is unknown whether it is the process of DNL or the accumulation of SFA per se that leads to hepatic insulin resistance. Therefore, it is of interest to compare the effect of a diet that modifies directly hepatic SFA content (4-week high SFA diet) and a diet that changes SFA indirectly by modifying rates of DNL (4-week high fructose diet). To this end, 18 overweight/obese, but otherwise healthy, males and females will take part in the randomized dietary interventions. 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.
Detailed description
Rationale: High rates of de novo lipogenesis (DNL) and high saturated fatty acid (SFA) fraction in the liver both have been associated with poor metabolic health and hepatic insulin resistance. Interestingly, the end product of DNL is mainly SFA. So far it is unknown whether it is the process of DNL or the accumulation of SFA per se that leads to hepatic insulin resistance. This is a clinically relevant question, as it will give novel insights towards the best strategy for prevention and treatment of hepatic insulin resistance. Therefore, it is of interest to compare the effect of a diet that modifies directly hepatic SFA content (high SFA diet) and a diet that changes SFA indirectly by modifying rates of DNL (high fructose diet).
Objective: To determine the effect of a 4-week high SFA diet compared to a 4-week high fructose diet on hepatic insulin sensitivity, on hepatic SFA fraction and DNL.
Study design: This is a randomized intervention study comparing the effects of a 4-week high SFA diet compared to a 4-week high fructose diet on hepatic insulin sensitivity.
Study population: 24 overweight/obese, but otherwise healthy, males and females (BMI 27-38 kg/m2), 45-75 years, will participate in the study. Of these 24 included participants, 18 are expected to meet the study criteria and take part in the measurements following the screening, of these 14 need to complete the study.
Intervention: Participants follow a 4-week high SFA diet and a 4-week high fructose diet.
Main study parameters/endpoints: 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 outcomes are DNL upon 4-week high SFA versus 4-week high fructose, and delta (baseline-end intervention) hepatic SFA fraction upon 4-week high SFA versus 4-week high fructose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fructose diet | Experimental | Other: High fructose dietParticipants will receive dietary products high in fructose for 4 weeks. |
| High saturated fat diet | Experimental | Other: High saturated fat dietParticipants will receive dietary products high in saturated fat for 4 weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fructose diet4 week high fructose diet. Intended composition (En%): Carbohydrates: 60-70 Fat: 20-30 Protein: 10-15 Fructose: 20 SFA: 5 | Other | High fructose diet |
| High saturated fat diet4 week high saturated fat diet. Intended composition (En%): Carbohydrates: 35-45 Fat: 40-50 Protein: 10-15 Fructose: 5 SFA: 20 | Other | High saturated fat diet |
Primary outcome
Hepatic insulin sensitivity measured by hyperinsulinemic-euglycemic clamp.
Time frame: after 28 days of each diet
difference in EGP suppression after the high SFA diet and the high fructose diet
2 secondary outcomes
Hepatic fat composition measured by proton magnetic resonance spectroscopy
Time frame: first day of each diet - after 28 days of each diet
De novo lipogenesis measured by deuterated water
Time frame: after 25 days of each diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No. Data can be obtained with the principal investigator if desired.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Schrauwen-Hinderling, Dr principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fructose diet and High saturated fat diet in people with Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic insulin sensitivity measured by hyperinsulinemic-euglycemic clamp. (time frame: after 28 days of each diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.