Healthy Normal WeightFEEDNCT04041752
Meal Texture and Satiety
A study testing SOLID, LIQUID_P and LIQUID_L in people with Healthy Normal Weight, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of the present study is to compare the nutritional compensation between iso-caloric meals of various textures (liquid vs solid) in health young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Normal Weight
- What is being tested?
- SOLID, LIQUID_P and LIQUID_L
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 30 Nov 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being aged 18 to 25 years old
- Being normal weight with a BMI between 20 and 25 kg/m²
- Being registered with a social security number
Who cannot join
- Eating disorders
- Specific food allergies or habits
- being under diet
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Yves Boirie
About this study
Official title: Satietogenic Effect of Liquid Versus Solid Meals in Healthy Adults
The aim of the present study is to compare the nutritional compensation between iso-caloric meals of various textures (liquid vs solid) in health young adults.
Read the detailed description
The present study will compare the potential energy intake compensations, appetite feelings response, food reward variations and satiating responses after the ingestion of three different lunch meals: i) one classical cooked meal; ii) one iso-energetic meal consumed using a pre-prepared liquid meal; iii) one iso-energetic meal consumed using a prepared liquid meal. This will be the first study to assess all these nutritional factors after such meals.
- Conditions
- Healthy Normal Weight
- Being tested
- SOLID, LIQUID_P, LIQUID_L
- Keywords
- Meal texture, Appetite, Energy compensation, Food reward
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLIDBehavioural
condition with a classical meal served using solid food items
LIQUID_PBehavioural
condition with a liquid meal served using a powder solution
LIQUID_LBehavioural
condition with a pre-prepared meal served using a liquid solution.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Experimental | 30 healthy normal weight adults will be involved and will realize the three conditions Receives: Behavioral: SOLID; Behavioral: LIQUID_P; Behavioral: LIQUID_L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spontaneous Energy intake measured
spontaneous food intake will be measured ad libitum for the 12 hours that will follow the laboratory sessions (between 02:00pm to 11:59 pm). The participants will be offered a food bag composed of items they like and proposed ad libiutm and will be asked to only conume food from this bag for the rest of the day. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software.
Measured: day 1 , day 8, day 15
Secondary outcomes (2)
Hunger feelings
hunger area under the curve will be assessed using visual analogue scale through a the day
Measured: day 1 , day 8, day 15
Food reward
The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)
Measured: day 1 , day 8, day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Normal WeightStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants complete the same conditions
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Appetite Control and Energy Balance Research Group, UNiversity of Leeds, Leeds, UK, Université d'Auvergne
- Responsible party
- Sponsor
- Investigators
- yves Boirie, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041752
- Sponsor's protocol ID
- RBHP 2018 BOIRIE 2
- Other IDs
- 2019-A00033-54
- Acronym
- FEED
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satietogenic Effect of Liquid Versus Solid Meals in Healthy Adults
- ClinicalTrials.gov ID
- NCT04041752
- Acronym / sponsor ID
- FEED / RBHP 2018 BOIRIE 2
- Conditions
- Healthy Normal Weight
- Keywords
- Meal texture, Appetite, Energy compensation, Food reward
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Appetite Control and Energy Balance Research Group, UNiversity of Leeds, Leeds, UK, Université d'Auvergne
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 1 Aug 2019 (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 aim of the present study is to compare the nutritional compensation between iso-caloric meals of various textures (liquid vs solid) in health young adults.
Detailed description
The present study will compare the potential energy intake compensations, appetite feelings response, food reward variations and satiating responses after the ingestion of three different lunch meals: i) one classical cooked meal; ii) one iso-energetic meal consumed using a pre-prepared liquid meal; iii) one iso-energetic meal consumed using a prepared liquid meal. This will be the first study to assess all these nutritional factors after such meals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants complete the same conditions
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Experimental | Behavioral: SOLID, Behavioral: LIQUID_P, Behavioral: LIQUID_L30 healthy normal weight adults will be involved and will realize the three conditions |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being aged 18 to 25 years old
- Being normal weight with a BMI between 20 and 25 kg/m²
- Being registered with a social security number
Key exclusion criteria (3 listed)
- Eating disorders
- Specific food allergies or habits
- being under diet
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 |
|---|---|---|
| SOLIDcondition with a classical meal served using solid food items | Behavioural | Normal weight |
| LIQUID_Pcondition with a liquid meal served using a powder solution | Behavioural | Normal weight |
| LIQUID_Lcondition with a pre-prepared meal served using a liquid solution. | Behavioural | Normal weight |
Primary outcome
Change in Spontaneous Energy intake measured
Time frame: day 1 , day 8, day 15
spontaneous food intake will be measured ad libitum for the 12 hours that will follow the laboratory sessions (between 02:00pm to 11:59 pm). The participants will be offered a food bag composed of items they like and proposed ad libiutm and will be asked to only conume food from this bag for the rest of the day. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software.
2 secondary outcomes
Hunger feelings
Time frame: day 1 , day 8, day 15
Food reward
Time frame: day 1 , day 8, day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
Related trials for Healthy Normal Weight
Active, not recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants
Overweight , Obesity
Active, not recruitingPhase 1
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
Healhty, Overweight or Obesity
Active, not recruitingPhase 1
A Study to Test How BI 3034701 is Taken up and Processed by the Body in Healthy Men With Normal Weight or Overweight
Healthy
Not yet recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Not yet recruiting
A Method Characterization Study to Evaluate Thermoregulatory Sweat Production in Healthy Volunteers and Patients With ROSAH Syndrome)
ROSAH Syndrome, Anhidrosis
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.
yves Boirie principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOLID, LIQUID_P and LIQUID_L in people with Healthy Normal Weight, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 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 1 Aug 2019. 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 France. 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?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spontaneous Energy intake measured (time frame: day 1 , day 8, day 15). 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 1 Aug 2019.