Bariatric Surgery CandidateCIBuSNCT04990947
Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention
An observational study of Bariatric Surgery Candidate and Lifestyle, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement. Read more about this study
- Who is it for?
- Ages 18 to 67 years, women only
- Conditions the study is for
- Bariatric Surgery Candidate, Lifestyle, Obesity
- What is being tested?
- lifestyle / RYGB
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Apr 2021to 31 Dec 2023
- 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 67 years
- Women only
- Adult, Older adult
Study population: RYGB or obesity with lifestyle intervention
Who may be able to join
- Woman
- Age between 18 and 67 years of age (standard for eligibility for bariatric surgery)
- Patients must be able to adhere to the study visit schedule
- Independently mobile
- Patients must be able to give informed consent (IC) prior to any study procedures
- Surgical (1) and non-surgical (2) groups:
- Eligible for bariatric surgery (BMI > 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria)
- Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program
Who cannot join
- Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as: Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal
- Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal.
- Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus)
- Pregnancy or lactation, or planning to get pregnant during the study period
- Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose)
- Active and significant psychiatric illness including substance misuse
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- Significant cognitive or communication issues
- Medications with documented effect on food intake or food preference
- Participating in another scientific study at the same time, if
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Yonta van der Burgh
Arnhem, 6815 AD
Yonta van der Burgh, MSc, MD, 0880058888, Yvanderburgh@Rijnstate.nl
About this study
To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.
- Conditions
- Bariatric Surgery Candidate, Lifestyle, Obesity
- Being tested
- lifestyle / RYGB
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle / RYGBOther
No intervention, just 2 different groups will be included
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery (Roux-en-Y Gastric Bypass) | Patients who are eligible for RYGB Receives: Other: lifestyle / RYGB | |
| Lifestyle group | Patients with a BMI > 30 who will start a lifestyle program Receives: Other: lifestyle / RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in caloric intake
kcal consumed
Measured: Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle
Secondary outcomes (3)
Weight / BMI
weight and height measurements
Measured: baseline, 4weeks, 3 months, 6 months, 12 months
Drinking microstructure over time
Measured with the drinkometer
Measured: baseline, 4weeks, 3 months, 6 months, 12 months
Change in self-reported hunger, thirst, fullness, preference
VAS scale 0-100
Measured: baseline, 4weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start7 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990947
- Sponsor's protocol ID
- 2020-1594
- Acronym
- CIBuS
- Status last verified
- Feb 2021
- First submitted
- 23 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT04990947
- Acronym / sponsor ID
- CIBuS / 2020-1594
- Conditions
- Bariatric Surgery Candidate, Lifestyle, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 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.
To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery (Roux-en-Y Gastric Bypass) | – | Other: lifestyle / RYGBPatients who are eligible for RYGB |
| Lifestyle group | – | Other: lifestyle / RYGBPatients with a BMI > 30 who will start a lifestyle program |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- RYGB or obesity with lifestyle intervention
Key inclusion criteria (8 listed)
- Woman
- Age between 18 and 67 years of age (standard for eligibility for bariatric surgery)
- Patients must be able to adhere to the study visit schedule
- Independently mobile
- Patients must be able to give informed consent (IC) prior to any study procedures
Key exclusion criteria (9 listed)
- Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as: Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal
- Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal.
- Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus)
- Pregnancy or lactation, or planning to get pregnant during the study period
- Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose)
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 |
|---|---|---|
| lifestyle / RYGBNo intervention, just 2 different groups will be included | Other | Bariatric surgery (Roux-en-Y Gastric Bypass), Lifestyle group |
Primary outcome
Changes in caloric intake
Time frame: Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle
kcal consumed
3 secondary outcomes
Weight / BMI
Time frame: baseline, 4weeks, 3 months, 6 months, 12 months
Drinking microstructure over time
Time frame: baseline, 4weeks, 3 months, 6 months, 12 months
Change in self-reported hunger, thirst, fullness, preference
Time frame: baseline, 4weeks, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- 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?
An observational study of Bariatric Surgery Candidate and Lifestyle, run by Rijnstate Hospital 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 8 inclusion and 9 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 5 Aug 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?
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?
Changes in caloric intake (time frame: Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle). 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 5 Aug 2021.