Diet HabitNCT05142657
Are There Dietary Factors Affecting the Development of Pancreatitis in Patients With Gallstones?
An observational study of Diet Habit and Gall Stone, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The most common cause of acute pancreatitis is gallstones. It is known that diet and obesity play a role in the formation of gallstones. It has been reported that the risk of gallstone formation is two times higher in obese individuals with a body mass index (BMI) >30 than in normal-weight individuals with a BMI… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diet Habit, Gall Stone, Pancreatitis
- What is being tested?
- diet survey
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Dec 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the participants have gallstone. In control group participants did not have any pancreatitis history. In case group patients have pancreatitis.
Who may be able to join
- 18-80 years of age,
- having gallbladder stones
- being diagnosed with pancreatitis, exclusion criteria in the pancreatitis group were:
- having any cancer,
- being pregnant,
- having chronic liver or kidney disease,
Show all 15Show fewer
- icterus,
- developing after ERCP.
- 18-80 years of age
- gallbladder stones, exclusion criteria in the control group were:
- any cancer,
- pregnancy,
- chronic liver or kidney disease,
- icterus,
- previous pancreatitis attack
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Traininng and Research Hospital
Istanbul, 34371
About this study
The most common cause of acute pancreatitis is gallstones. It is known that diet and obesity play a role in the formation of gallstones. It has been reported that the risk of gallstone formation is two times higher in obese individuals with a body mass index (BMI) >30 than in normal-weight individuals with a BMI between 20-25. The epidemiological literature on the relationship between diet and risk of acute pancreatitis is very limited. In addition, it is often unclear which type (acute, recurrent, or chronic) and subtype (gallstone-related or non-gallstone-related) of acute pancreatitis is studied in studies. Although there are studies in the literature evaluating the relationship between diet and development of gallstones or the development of pancreatitis with diet, studies examining the role of diet in the development of pancreatitis in patients with gallstones are very limited. In this study, we aimed to investigate the dietary differences in patients with gallstones who had pancreatitis and those who did not.
Read the detailed description
The incidence of acute pancreatitis has been reported as 4.9-35/100.000, and the incidence increases every year with the increase in obesity and gallstone rates. It is most commonly observed between the ages of 30-60 and no difference was found in terms of gender distribution. The most common cause of acute pancreatitis is gallstones. Alcohol use, drugs and other reasons come next.
It is known that diet and obesity play a role in the formation of gallstones. It has been reported that the risk of gallstone formation is two times higher in obese individuals with a body mass index (BMI) >30 than in normal-weight individuals with a BMI between 20-25. In addition, many studies have reported that increased use of dietary refined carbohydrates and triglycerides and reduced dietary fiber intake are associated with gallstone formation.
The epidemiological literature on the relationship between diet and risk of acute pancreatitis is very limited. In addition, it is often unclear which type (acute, recurrent, or chronic) and subtype (gallstone-related or non-gallstone-related) of acute pancreatitis is studied in studies. On the other hand, Sarles et al. In a comprehensive study conducted in 1973, he reported that high fat and protein consumption and alcoholism increase the risk of pancreatitis, regardless of etiology. Few case-control and ecological studies have evaluated the effect of protein, fat, and carbohydrate intakes on alcohol-related or gallstone-related acute pancreatitis risk or non-gallstone-related acute pancreatitis risk or acute pancreatitis mortality.
At the beginning of the twentieth century, an inverse relationship between coffee consumption and the risk of alcohol-induced acute pancreatitis was observed in a prospective study, and an inverse relationship with fruit consumption in two smaller case-control studies, and a positive association with consumption of freshwater fish and parboiled rice. In parallel, overly large meals and food allergies after a long period of fasting have been reported to be risk factors for acute pancreatitis.
Although there are studies in the literature evaluating the relationship between diet and development of gallstones or the development of pancreatitis with diet, studies examining the role of diet in the development of pancreatitis in patients with gallstones are very limited. In this study, we aimed to investigate the dietary differences in patients with gallstones who had pancreatitis and those who did not.
In the study, age, gender, body mass index, alcohol and cigarette consumption status, daily physical activity status, eating frequency, frequency of food consumption for three days, and their food consumption status will be evaluated with the BeBis 8 Full version program and it will be compared whether there is a difference between patients who had pancreatitis and those who did not. .
- Conditions
- Diet Habit, Gall Stone, Pancreatitis
- Being tested
- diet survey
- Keywords
- meat, egg, fat, protein
- Medical subject headings
- Feeding Behavior, Gallstones, Pancreatitis, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet surveyOther
Dietary survey applied to all participants
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients who have gallstone pancreatitis Receives: Other: diet survey | |
| Control | Patients who have only gallstone Receives: Other: diet survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy, cholesterol, protein, fat
Daily energy, cholesterol, protein, fat intake of the participants
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Jun 2021
- Primary completion20 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Istanbul Training and Research Hospital
- Investigators
- Ufuk O İdiz, M.D, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142657
- Sponsor's protocol ID
- Pancreatitis diet
- Status last verified
- Nov 2021
- First submitted
- 21 Nov 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Setiawan VW, Pandol SJ, Porcel J, Wei PC, Wilkens LR, Le Marchand L, Pike MC, Monroe KR. Dietary Factors Reduce Risk of Acute Pancreatitis in a Large Multiethnic Cohort. Clin Gastroenterol Hepatol. 2017 Feb;15(2):257-265.e3. doi: 10.1016/j.cgh.2016.08.038. Epub 2016 Sep 5.
PubMed 27609706Dugum M, Gougol A, Paragomi P, Gao X, Matta B, Yazici C, Tang G, Greer P, Pothoulakis I, O'Keefe SJD, Whitcomb DC, Yadav D, Papachristou GI. Association of Dietary Habits with Severity of Acute Pancreatitis. Curr Dev Nutr. 2018 Oct 8;2(12):nzy075. doi: 10.1093/cdn/nzy075. eCollection 2018 Dec.
PubMed 30569031
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are There Dietary Factors Affecting the Development of Pancreatitis in Patients With Gallstones?
- ClinicalTrials.gov ID
- NCT05142657
- Acronym / sponsor ID
- Pancreatitis diet
- Conditions
- Diet Habit, Gall Stone, Pancreatitis
- Keywords
- meat, egg, fat, protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 2 Dec 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.
The most common cause of acute pancreatitis is gallstones. It is known that diet and obesity play a role in the formation of gallstones. It has been reported that the risk of gallstone formation is two times higher in obese individuals with a body mass index (BMI) >30 than in normal-weight individuals with a BMI between 20-25. The epidemiological literature on the relationship between diet and risk of acute pancreatitis is very limited. In addition, it is often unclear which type (acute, recurrent, or chronic) and subtype (gallstone-related or non-gallstone-related) of acute pancreatitis is studied in studies. Although there are studies in the literature evaluating the relationship between diet and development of gallstones or the development of pancreatitis with diet, studies examining the role of diet in the development of pancreatitis in patients with gallstones are very limited. In this study, we aimed to investigate the dietary differences in patients with gallstones who had pancreatitis and those who did not.
Detailed description
The incidence of acute pancreatitis has been reported as 4.9-35/100.000, and the incidence increases every year with the increase in obesity and gallstone rates. It is most commonly observed between the ages of 30-60 and no difference was found in terms of gender distribution. The most common cause of acute pancreatitis is gallstones. Alcohol use, drugs and other reasons come next.
It is known that diet and obesity play a role in the formation of gallstones. It has been reported that the risk of gallstone formation is two times higher in obese individuals with a body mass index (BMI) >30 than in normal-weight individuals with a BMI between 20-25. In addition, many studies have reported that increased use of dietary refined carbohydrates and triglycerides and reduced dietary fiber intake are associated with gallstone formation.
The epidemiological literature on the relationship between diet and risk of acute pancreatitis is very limited. In addition, it is often unclear which type (acute, recurrent, or chronic) and subtype (gallstone-related or non-gallstone-related) of acute pancreatitis is studied in studies. On the other hand, Sarles et al. In a comprehensive study conducted in 1973, he reported that high fat and protein consumption and alcoholism increase the risk of pancreatitis, regardless of etiology. Few case-control and ecological studies have evaluated the effect of protein, fat, and carbohydrate intakes on alcohol-related or gallstone-related acute pancreatitis risk or non-gallstone-related acute pancreatitis risk or acute pancreatitis mortality.
At the beginning of the twentieth century, an inverse relationship between coffee consumption and the risk of alcohol-induced acute pancreatitis was observed in a prospective study, and an inverse relationship with fruit consumption in two smaller case-control studies, and a positive association with consumption of freshwater fish and parboiled rice. In parallel, overly large meals and food allergies after a long period of fasting have been reported to be risk factors for acute pancreatitis.
Although there are studies in the literature evaluating the relationship between diet and development of gallstones or the development of pancreatitis with diet, studies examining the role of diet in the development of pancreatitis in patients with gallstones are very limited. In this study, we aimed to investigate the dietary differences in patients with gallstones who had pancreatitis and those who did not.
In the study, age, gender, body mass index, alcohol and cigarette consumption status, daily physical activity status, eating frequency, frequency of food consumption for three days, and their food consumption status will be evaluated with the BeBis 8 Full version program and it will be compared whether there is a difference between patients who had pancreatitis and those who did not. .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: diet surveyPatients who have gallstone pancreatitis |
| Control | – | Other: diet surveyPatients who have only gallstone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the participants have gallstone. In control group participants did not have any pancreatitis history. In case group patients have pancreatitis.
Key inclusion criteria (15 listed)
- 18-80 years of age,
- having gallbladder stones
- being diagnosed with pancreatitis, exclusion criteria in the pancreatitis group were:
- having any cancer,
- being pregnant,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| diet surveyDietary survey applied to all participants | Other | Case, Control |
Primary outcome
energy, cholesterol, protein, fat
Time frame: 3 days
Daily energy, cholesterol, protein, fat intake of the participants
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 14 Apr 2022.
- Background: PubMed 27609706Setiawan VW, Pandol SJ, Porcel J, Wei PC, Wilkens LR, Le Marchand L, Pike MC, Monroe KR. Dietary Factors Reduce Risk of Acute Pancreatitis in a Large Multiethnic Cohort. Clin Gastroenterol Hepatol. 2017 Feb;15(2):257-265.e3. doi: 10.1016/j.cgh.2016.08.038. Epub 2016 Sep 5.
- Background: PubMed 30569031Dugum M, Gougol A, Paragomi P, Gao X, Matta B, Yazici C, Tang G, Greer P, Pothoulakis I, O'Keefe SJD, Whitcomb DC, Yadav D, Papachristou GI. Association of Dietary Habits with Severity of Acute Pancreatitis. Curr Dev Nutr. 2018 Oct 8;2(12):nzy075. doi: 10.1093/cdn/nzy075. eCollection 2018 Dec.
- 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.
Ufuk O İdiz, M.D principal investigator
Istanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit and Gall Stone, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 15 inclusion and 0 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 14 Apr 2022. 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 Turkey (Türkiye). 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?
energy, cholesterol, protein, fat (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142657, which also lists 2 linked publications.
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 14 Apr 2022.