Intermittent FastingNCT04355910
Intermittent Fasting in Nonalcoholic Fatty Liver Disease
A study testing Calorie restriction in people with Intermittent Fasting and Non-Alcoholic Fatty Liver Disease, run by Shaoguan University at 1 site in China.
Trial summary
Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intermittent Fasting, Non-Alcoholic Fatty Liver Disease, Insulin Resistance
- What is being tested?
- Calorie restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Aug 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.
Who cannot join
- Excessive alcohol consumption (ethanol > 140 g/wk for men and > 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Medical University
Dongguan, Guangdong, 523808
Peiwen Zhang, M. D., 86-769-22896572, 313743920@qq.com
Xuebin Gao, M. D., 86-18819747104, 401779114@qq.com
About this study
Official title: Effects of Intermittent and Continuous Calorie Restriction on Body Weight and Metabolism in Adults With Nonalcoholic Fatty Liver Disease
Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.
- Conditions
- Intermittent Fasting, Non-Alcoholic Fatty Liver Disease, Insulin Resistance, Obesity, Gut Microbiota
- Being tested
- Calorie restriction
- Medical subject headings
- Intermittent Fasting, Non-alcoholic Fatty Liver Disease, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restrictionBehavioural
Participants randomized to IFD were asked to restrict energy and carbohydrate on two non-consecutive days each week (75% energy restriction) and to consume a plant foods-based diet that met their estimated energy requirements for the remaining 5 d of the week.
The CCR group was prescribed a daily plant foods-based diet that was relatively low in fat with moderate energy-restriction (25% energy restriction).
The plant foods-based diet included adequate fruit and vegetable, nuts and seeds, whole-grain cereals, olive oil, fish and seafood, a moderate consumption of dairy products, poultry, eggs, and lean red meat.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting mimic-diet (IFD) | Experimental | Restrict 75% energy on two non-consecutive days each week. Receives: Behavioral: Calorie restriction |
| Continuous calorie restriction (CCR) | Active comparator | A daily 25% energy-restricted Mediterranean-type diet Receives: Behavioral: Calorie restriction |
| Control | No intervention | No advice to restrict energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Change of body weight
Measured: Change from baseline body weight at week 8
Secondary outcomes (3)
Lipid profile
Plasma lipids levels
Measured: Change from baseline plasma TG, TC and LDL at week 8
Insulin resistance
Plasma glucose and insulin levels
Measured: Change from baseline plasma glucose and insulin at week 8
Gut microbiota
Changes of blood metabolites and the gut microbiome
Measured: Change from baseline plasma bile acids and the gut microbiome at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Jan 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaoguan University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Medical University, Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355910
- Sponsor's protocol ID
- SGU-05
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent and Continuous Calorie Restriction on Body Weight and Metabolism in Adults With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04355910
- Acronym / sponsor ID
- SGU-05
- Conditions
- Intermittent Fasting, Non-Alcoholic Fatty Liver Disease, Insulin Resistance, Obesity, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shaoguan UniversityUniversity, hospital or other
- Collaborators
- Guangdong Medical University, Sun Yat-sen University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 21 Apr 2020 (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.
Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting mimic-diet (IFD) | Experimental | Behavioral: Calorie restrictionRestrict 75% energy on two non-consecutive days each week. |
| Continuous calorie restriction (CCR) | Active comparator | Behavioral: Calorie restrictionA daily 25% energy-restricted Mediterranean-type diet |
| Control | No intervention | –No advice to restrict energy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.
Key exclusion criteria (1 listed)
- Excessive alcohol consumption (ethanol > 140 g/wk for men and > 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.
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 |
|---|---|---|
| Calorie restrictionParticipants randomized to IFD were asked to restrict energy and carbohydrate on two non-consecutive days each week (75% energy restriction) and to consume a plant foods-based diet that met their estimated energy requirements for the remaining 5 d of the week. The CCR group was prescribed a daily plant foods-based diet that was relatively low in fat with moderate energy-restriction (25% energy restriction). The plant foods-based diet included adequate fruit and vegetable, nuts and seeds, whole-grain cereals, olive oil, fish and seafood, a moderate consumption of dairy products, poultry, eggs, and lean red meat. | Behavioural | Continuous calorie restriction (CCR), Intermittent fasting mimic-diet (IFD) |
Primary outcome
Body weight
Time frame: Change from baseline body weight at week 8
Change of body weight
3 secondary outcomes
Lipid profile
Time frame: Change from baseline plasma TG, TC and LDL at week 8
Insulin resistance
Time frame: Change from baseline plasma glucose and insulin at week 8
Gut microbiota
Time frame: Change from baseline plasma bile acids and the gut microbiome at week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie restriction in people with Intermittent Fasting and Non-Alcoholic Fatty Liver Disease, run by Shaoguan University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Change from baseline body weight at week 8). 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 21 Apr 2020.