Fatty Liver, NonalcoholicNCT04054297
Glycemic Index/Saturated Fatty Acid Diet and Hepatic Fat
A study testing High GI/SFA diet and Low GI/SFA diet in people with Fatty Liver, Nonalcoholic and Diet, Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Excessive fat in the liver is associated with impairments in metabolic health. Reducing the amount of carbohydrates and fat both have been shown to reduce liver fat. However, not only the amount fats and carbohydrates, but also their quality have been shown to influence liver fat. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver, Nonalcoholic, Diet, Healthy, Obesity
- What is being tested?
- High GI/SFA diet and Low GI/SFA diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2019to 23 Mar 2021
- 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
- Caucasian
- Male or postmenopausal female
- Aged 45-75 years at start of the study
- Body mass index (BMI) 27 - 38 kg/m2
- Stable dietary habits (no weight loss or gain >3kg in the past 3 months) Sedentary lifestyle (not more than 2 hours of sports per week)
- TG between 1.0 and 4.0 mmol/L
Who cannot join
- Type 2 diabetes
- Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's or dependent physician's opinion interfere with the study
- Contra-indication for MRI (which can be found in appendix II)
- Alcohol consumption of >2 servings per day
- Smoking
- Use of medication known to interfere with the safety of study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Low Compared to a High Glycemic Index/Saturated Fatty Acid Diet on Hepatic Fat
Excessive fat in the liver is associated with impairments in metabolic health. Reducing the amount of carbohydrates and fat both have been shown to reduce liver fat. However, not only the amount fats and carbohydrates, but also their quality have been shown to influence liver fat. Diets high in saturated fatty acids (SFA) and diets with a high glycemic index (GI) have been shown to increase liver fat content. However, available data from human dietary intervention studies is limited and these studies did not reflect a realistic diet. In the present study a combination of low GI/SFA on the one hand and high GI/SFA on the other hand is used to reflect realistically a healthy and an unhealthy diet as they are actually consumed by the Dutch population.
The primary objective of this study is to investigate whether a two-week low compared to high GI/SFA diet reduces liver fat content. In addition, it will be investigated whether a two- week low compared to high GI/SFA diet reduces DNL, lowers the 24-hour glycemic response, lowers hepatic glycogen content, increases hepatic fat oxidation and changes hepatic lipid composition. Furthermore, the metabolic response to a meal (metabolites related to energy metabolism and substrate oxidation) will be studied upon the low and high GI/SFA diets.
Read the detailed description
Rationale:
Excessive fat in the liver is associated with impairments in metabolic health. Reducing the amount of carbohydrates and fat both have been shown to reduce liver fat. However, not only the amount fats and carbohydrates, but also their quality have been shown to influence liver fat. Diets high in saturated fatty acids (SFA) and diets with a high glycemic index (GI) have been shown to increase liver fat content. However, available data from human dietary intervention studies is limited and these studies did not reflect a realistic diet. Here the investigators want to combine low GI/SFA on the one hand and high GI/SFA on the other hand to reflect realistically a healthy and an unhealthy diet as they are actually consumed by the Dutch population. It is hypothesized that such a low compared to a high GI/SFA diet reduces liver fat content and possibly liver fat composition. Furthermore, underlying pathways involved in mediating those changes in liver fat are largely unknown. Hepatic lipid storage can originate from several metabolic pathways, including de novo lipogenesis (DNL) or decreased hepatic fat oxidation. Based on current literature the investigators hypothesize that with the diets chosen here, both DNL (by differences in GI) and fat oxidation (by differences in fat composition) will be involved in causing changes in liver fat.
Objective:
The primary objective of this study is to investigate whether a two-week low compared to high GI/SFA diet reduces liver fat content. In addition, it will be investigated whether a two- week low compared to high GI/SFA diet reduces DNL, lowers the 24-hour glycemic response, lowers hepatic glycogen content, increases hepatic fat oxidation and changes hepatic lipid composition. Furthermore, the metabolic response to a meal (metabolites related to energy metabolism and substrate oxidation) will be studied upon the low and high GI/SFA diets.
Study design:
This is a randomized cross-over study comparing the effects of a high GI/SFA compared to a low GI/SFA diet.
Study population:
Up to seventeen healthy overweight/obese males and postmenopausal females, aged between 45-75 years and BMI between 27-38 kg/m2 will participate in the study (minimally 13 volunteers need to finish the study).
- Conditions
- Fatty Liver, Nonalcoholic, Diet, Healthy, Obesity
- Being tested
- High GI/SFA diet, Low GI/SFA diet
- Keywords
- NAFLD, Diet, Glycemic index
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High GI/SFA dietBehavioural
Subject will adhere to a 2 week high GI/SFA diet.
Low GI/SFA dietBehavioural
Subject will adhere to a 2 week low GI/SFA diet.
| Study group | Role | What they receive |
|---|---|---|
| High GI/SFA diet | Experimental | Subjects will adhere to a two-week high GI and high SFA diet. Crossover design, randomly assigned to start with either high GI/SFA or low GI/SFA. 4 week washout between the two diets. Receives: Behavioral: High GI/SFA diet |
| Low GI/SFA diet | Experimental | Subjects will adhere to a two-week low GI and low SFA diet. Crossover design, randomly assigned to start with either high GI/SFA or low GI/SFA. 4 week washout between the two diets. Receives: Behavioral: Low GI/SFA diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic fat content
Expressed as a percentage, measured by 1H-MRS
Measured: 20 minutes
Secondary outcomes (3)
Hepatic De Novo Lipogenesis
Percentage of palmitate in VLDL-TG originating from DNL
Measured: 20 hours
Hepatic fat composition (%SFA, MUFA, PUFA)
Measured by 1H-MRS
Measured: 20 minutes
Hepatic glycogen content
Measured by 13C-MRS
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start22 Jul 2019
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Vera Schrauwen-Hinderling, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054297
- Sponsor's protocol ID
- NL69685.068.19
- Status last verified
- Jul 2021
- First submitted
- 1 Aug 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low Compared to a High Glycemic Index/Saturated Fatty Acid Diet on Hepatic Fat
- ClinicalTrials.gov ID
- NCT04054297
- Acronym / sponsor ID
- NL69685.068.19
- Conditions
- Fatty Liver, Nonalcoholic, Diet, Healthy, Obesity
- Keywords
- NAFLD, Diet, Glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 13 Aug 2019 (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.
Excessive fat in the liver is associated with impairments in metabolic health. Reducing the amount of carbohydrates and fat both have been shown to reduce liver fat. However, not only the amount fats and carbohydrates, but also their quality have been shown to influence liver fat. Diets high in saturated fatty acids (SFA) and diets with a high glycemic index (GI) have been shown to increase liver fat content. However, available data from human dietary intervention studies is limited and these studies did not reflect a realistic diet. In the present study a combination of low GI/SFA on the one hand and high GI/SFA on the other hand is used to reflect realistically a healthy and an unhealthy diet as they are actually consumed by the Dutch population.
The primary objective of this study is to investigate whether a two-week low compared to high GI/SFA diet reduces liver fat content. In addition, it will be investigated whether a two- week low compared to high GI/SFA diet reduces DNL, lowers the 24-hour glycemic response, lowers hepatic glycogen content, increases hepatic fat oxidation and changes hepatic lipid composition. Furthermore, the metabolic response to a meal (metabolites related to energy metabolism and substrate oxidation) will be studied upon the low and high GI/SFA diets.
Detailed description
Rationale:
Excessive fat in the liver is associated with impairments in metabolic health. Reducing the amount of carbohydrates and fat both have been shown to reduce liver fat. However, not only the amount fats and carbohydrates, but also their quality have been shown to influence liver fat. Diets high in saturated fatty acids (SFA) and diets with a high glycemic index (GI) have been shown to increase liver fat content. However, available data from human dietary intervention studies is limited and these studies did not reflect a realistic diet. Here the investigators want to combine low GI/SFA on the one hand and high GI/SFA on the other hand to reflect realistically a healthy and an unhealthy diet as they are actually consumed by the Dutch population. It is hypothesized that such a low compared to a high GI/SFA diet reduces liver fat content and possibly liver fat composition. Furthermore, underlying pathways involved in mediating those changes in liver fat are largely unknown. Hepatic lipid storage can originate from several metabolic pathways, including de novo lipogenesis (DNL) or decreased hepatic fat oxidation. Based on current literature the investigators hypothesize that with the diets chosen here, both DNL (by differences in GI) and fat oxidation (by differences in fat composition) will be involved in causing changes in liver fat.
Objective:
The primary objective of this study is to investigate whether a two-week low compared to high GI/SFA diet reduces liver fat content. In addition, it will be investigated whether a two- week low compared to high GI/SFA diet reduces DNL, lowers the 24-hour glycemic response, lowers hepatic glycogen content, increases hepatic fat oxidation and changes hepatic lipid composition. Furthermore, the metabolic response to a meal (metabolites related to energy metabolism and substrate oxidation) will be studied upon the low and high GI/SFA diets.
Study design:
This is a randomized cross-over study comparing the effects of a high GI/SFA compared to a low GI/SFA diet.
Study population:
Up to seventeen healthy overweight/obese males and postmenopausal females, aged between 45-75 years and BMI between 27-38 kg/m2 will participate in the study (minimally 13 volunteers need to finish the study).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High GI/SFA diet | Experimental | Behavioral: High GI/SFA dietSubjects will adhere to a two-week high GI and high SFA diet. Crossover design, randomly assigned to start with either high GI/SFA or low GI/SFA. 4 week washout between the two diets. |
| Low GI/SFA diet | Experimental | Behavioral: Low GI/SFA dietSubjects will adhere to a two-week low GI and low SFA diet. Crossover design, randomly assigned to start with either high GI/SFA or low GI/SFA. 4 week washout between the two diets. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caucasian
- Male or postmenopausal female
- Aged 45-75 years at start of the study
- Body mass index (BMI) 27 - 38 kg/m2
- Stable dietary habits (no weight loss or gain >3kg in the past 3 months) Sedentary lifestyle (not more than 2 hours of sports per week)
Key exclusion criteria (6 listed)
- Type 2 diabetes
- Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's or dependent physician's opinion interfere with the study
- Contra-indication for MRI (which can be found in appendix II)
- Alcohol consumption of >2 servings per day
- Smoking
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 GI/SFA dietSubject will adhere to a 2 week high GI/SFA diet. | Behavioural | High GI/SFA diet |
| Low GI/SFA dietSubject will adhere to a 2 week low GI/SFA diet. | Behavioural | Low GI/SFA diet |
Primary outcome
Hepatic fat content
Time frame: 20 minutes
Expressed as a percentage, measured by 1H-MRS
3 secondary outcomes
Hepatic De Novo Lipogenesis
Time frame: 20 hours
Hepatic fat composition (%SFA, MUFA, PUFA)
Time frame: 20 minutes
Hepatic glycogen content
Time frame: 20 minutes
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 20 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Fatty Liver, Nonalcoholic
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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, PhD 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 GI/SFA diet and Low GI/SFA diet in people with Fatty Liver, Nonalcoholic and Diet, Healthy, 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 6 inclusion and 6 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 20 Jul 2021. 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 fat content (time frame: 20 minutes). 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 20 Jul 2021.