Ketogen-based Therapeutic DietNCT02964806
Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients
A study testing Ordinary Diet, Modified Atkin's Diet and Ketogenic Diet in people with Ketogen-based Therapeutic Diet and Pancreaticobiliary Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Ketogen-based Therapeutic Diet, Pancreaticobiliary Cancer
- What is being tested?
- Ordinary Diet, Modified Atkin's Diet and Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2016to 1 Oct 2017
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age more than 19)
- Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
- Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer
Who cannot join
- Patient who denied clinical trial
- Diabetes Mellitus(DM) patient with DM complication
- Hyperlipidemia patient with vascular co-morbidity
- Impaired renal function or renal failure (GFP<90%)
Trial locations and contacts
1 site in 1 country.
About this study
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.
- Being tested
- Ordinary Diet, Modified Atkin's Diet, Ketogenic Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ordinary DietDietary supplement
Modified Atkin's DietDietary supplement
Ketogenic DietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ordinary Diet | Other | Ordinary Diet Receives: Dietary Supplement: Ordinary Diet |
| Modified Atkin's Diet | Other | Modified Atkin's Diet Receives: Dietary Supplement: Modified Atkin's Diet |
| Ketogenic Diet | Other | Ketogenic Diet Receives: Dietary Supplement: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Intake Rate(%) for postoperative diet
Diet Intake Rate(%) will be examined by dietary satisfaction questionnaires.
Measured: 3 days after the diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start7 Nov 2016
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogen-based Therapeutic DietStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964806
- Sponsor's protocol ID
- 4-2016-0799
- Status last verified
- Mar 2018
- First submitted
- 13 Nov 2016
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients
- ClinicalTrials.gov ID
- NCT02964806
- Acronym / sponsor ID
- 4-2016-0799
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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.
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ordinary Diet | Other | Dietary Supplement: Ordinary DietOrdinary Diet |
| Modified Atkin's Diet | Other | Dietary Supplement: Modified Atkin's DietModified Atkin's Diet |
| Ketogenic Diet | Other | Dietary Supplement: Ketogenic DietKetogenic Diet |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age more than 19)
- Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
- Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer
Key exclusion criteria (4 listed)
- Patient who denied clinical trial
- Diabetes Mellitus(DM) patient with DM complication
- Hyperlipidemia patient with vascular co-morbidity
- Impaired renal function or renal failure (GFP<90%)
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 |
|---|---|---|
| Ordinary Diet | Dietary supplement | Ordinary Diet |
| Modified Atkin's Diet | Dietary supplement | Modified Atkin's Diet |
| Ketogenic Diet | Dietary supplement | Ketogenic Diet |
Primary outcome
Food Intake Rate(%) for postoperative diet
Time frame: 3 days after the diet
Diet Intake Rate(%) will be examined by dietary satisfaction questionnaires.
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 15 Mar 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ordinary Diet, Modified Atkin's Diet and Ketogenic Diet in people with Ketogen-based Therapeutic Diet and Pancreaticobiliary Cancer, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 4 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 15 Mar 2018. 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 South Korea. 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?
Food Intake Rate(%) for postoperative diet (time frame: 3 days after the 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 15 Mar 2018.