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Status unknownNCT04990947CIBuSUpdated Aug 5, 2021

Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

An observational study in Bariatric Surgery Candidate, Lifestyle and Obesity, sponsored by Rijnstate Hospital. Status unknown at 1 site in Netherlands. Open to female participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2021-08-05.

Sponsored by Rijnstate Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
18 Years to 67 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Bariatric Surgery Candidate
  • Lifestyle
  • Obesity
03

In context

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

RYGB or obesity with lifestyle intervention

Inclusion criteria

  • 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:

    1. Eligible for bariatric surgery (BMI > 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria)
    2. Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No

Groups and cohorts

  • Bariatric surgery (Roux-en-Y Gastric Bypass)

    Patients who are eligible for RYGB

    Other: lifestyle / RYGB

  • Lifestyle group

    Patients with a BMI \> 30 who will start a lifestyle program

    Other: lifestyle / RYGB

Interventions

  • Otherlifestyle / RYGB

    No intervention, just 2 different groups will be included

06

What researchers measure

Primary outcomes

  1. Changes in caloric intake

    kcal consumed

    Time frame: Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle

Secondary outcomes

  1. Weight / BMI

    weight and height measurements

    Time frame: baseline, 4weeks, 3 months, 6 months, 12 months

  2. Drinking microstructure over time

    Measured with the drinkometer

    Time frame: baseline, 4weeks, 3 months, 6 months, 12 months

  3. Change in self-reported hunger, thirst, fullness, preference

    VAS scale 0-100

    Time frame: baseline, 4weeks, 3 months, 6 months, 12 months

07

Study locations

1 of 1 sites recruiting
  • Yonta van der Burgh
    Arnhem, 6815 AD, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04990947
Lead sponsor
Rijnstate Hospital
Responsible party
Sponsor
First posted
Aug 5, 2021
Start date
Apr 7, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Aug 5, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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