ObesityNCT01122082
Respiratory Quotient and Food Liking, Food Wanting and Food Consumption
A study testing food preloads in people with Obesity, run by University of Burgundy at 1 site in France.
Trial summary
The purpose of this study is to observe the influence of carbohydrate-to-fat balance on liking, wanting and food consumption in humans. 16 normal-weight men (age: 23 ± 3 y)had completed a randomized 4-condition crossover study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- food preloads
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Jan 2010
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good health
- Absence of medication
- Moderate physical activity (irregular and less than 5 h/wk)
- Low-smoking habit (less than 5 cigarettes/d)
- Normal body mass index (20< BMI <25)
Who cannot join
- Eating disorders
- Dieting or fasting
- Aversions for the foods offered and elevated 'cognitive restriction of eating' (score ≥ 7) according to the Three Factor Eating Questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Respiratory Quotient on Food Liking, Food Wanting, Macronutrient Selection and Food Consumption in Humans
The purpose of this study is to observe the influence of carbohydrate-to-fat balance on liking, wanting and food consumption in humans.
16 normal-weight men (age: 23 ± 3 y)had completed a randomized 4-condition crossover study. The sessions differed by the composition of the breakfast which was rich in carbohydrates (HCB), low in carbohydrates (LCB), rich in fat (HFB) and low in fat (LFB). The HCB and HFB contained 2072 kJ, while the LCB and LFB contained 565 kJ. Two hours and 20 min later, energy expenditure (EE) and respiratory quotient (RQ) were measured before olfactory liking for 4 foods items and then ad libitum energy intake (EI) during a snack (sweet and fatty toast) were evaluated.
Read the detailed description
In accordance with the carbohydrate-based models of feeding, one may expect that food choices as well as "liking" and "wanting" (the two components of the reward system) could be influenced by glycogen stores and the carbohydrate-to-fat balance. More precisely, one may expect that a high fat oxidation rate could increase liking and wanting carbohydrates to replenish glycogen stores and conversely, that a high carbohydrate oxidation rate could produce the reverse. In order to validate this hypothesis, the present study has been conducted to investigate in humans the influence of the carbohydrate-to-fat oxidation ratio on carbohydrate-to-fat selection and the food reward system.
- Conditions
- Obesity
- Being tested
- food preloads
- Keywords
- energy intake, energy expenditure, macronutrient selection
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food preloadsBehavioural
Also called food intake, metabolism
Subjects will eat in the morning during breakfast 300g cottage cheese (627kJ - 147kcal; 13.2g carbohydrate, 0.3g fat, 23g protein) plus, according to the situations, either: 90g sucrose, HCB); 6g aspartame; 40g vegetable oil; 40g paraffin oil. Therefore two breakfast will have the same energy content (2072kJ - 495kcal), as did the other two(565 kJ - 135kcal).
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory quotient
Respiratory quotient is the ratio of CO2 production on oxygen consumption measured in the expiratory flow
Measured: 6 months
Secondary outcomes (3)
food liking
Food liking is the preference for 4 food items smelt
Measured: 6 months
food wanting
food wanting is the selection of 4 kind of toasts during a snack
Measured: 6 months
food consumption
is the amount of food eaten during the snack
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Principal investigator, Laurent BRONDEL, University of Burgundy
- Investigators
- Luc Penicaud, MD, Study director, Centre National de la Recherche Scientifique, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122082
- Sponsor's protocol ID
- ABC123
- Other IDs
- CSGA-AA1234-01
- Status last verified
- Aug 2017
- First submitted
- 10 May 2010
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brondel L, Landais L, Romer MA, Holley A, Penicaud L. Substrate oxidation influences liking, wanting, macronutrient selection, and consumption of food in humans. Am J Clin Nutr. 2011 Sep;94(3):775-83. doi: 10.3945/ajcn.111.017319. Epub 2011 Jul 27.
PubMed 21795442
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Respiratory Quotient on Food Liking, Food Wanting, Macronutrient Selection and Food Consumption in Humans
- ClinicalTrials.gov ID
- NCT01122082
- Acronym / sponsor ID
- ABC123
- Conditions
- Obesity
- Keywords
- energy intake, energy expenditure, macronutrient selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 May 2010 (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.
The purpose of this study is to observe the influence of carbohydrate-to-fat balance on liking, wanting and food consumption in humans.
16 normal-weight men (age: 23 ± 3 y)had completed a randomized 4-condition crossover study. The sessions differed by the composition of the breakfast which was rich in carbohydrates (HCB), low in carbohydrates (LCB), rich in fat (HFB) and low in fat (LFB). The HCB and HFB contained 2072 kJ, while the LCB and LFB contained 565 kJ. Two hours and 20 min later, energy expenditure (EE) and respiratory quotient (RQ) were measured before olfactory liking for 4 foods items and then ad libitum energy intake (EI) during a snack (sweet and fatty toast) were evaluated.
Detailed description
In accordance with the carbohydrate-based models of feeding, one may expect that food choices as well as "liking" and "wanting" (the two components of the reward system) could be influenced by glycogen stores and the carbohydrate-to-fat balance. More precisely, one may expect that a high fat oxidation rate could increase liking and wanting carbohydrates to replenish glycogen stores and conversely, that a high carbohydrate oxidation rate could produce the reverse. In order to validate this hypothesis, the present study has been conducted to investigate in humans the influence of the carbohydrate-to-fat oxidation ratio on carbohydrate-to-fat selection and the food reward system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good health
- Absence of medication
- Moderate physical activity (irregular and less than 5 h/wk)
- Low-smoking habit (less than 5 cigarettes/d)
- Normal body mass index (20< BMI <25)
Key exclusion criteria (3 listed)
- Eating disorders
- Dieting or fasting
- Aversions for the foods offered and elevated 'cognitive restriction of eating' (score ≥ 7) according to the Three Factor Eating Questionnaire
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 |
|---|---|---|
| food preloadsAlso: food intake, metabolismSubjects will eat in the morning during breakfast 300g cottage cheese (627kJ - 147kcal; 13.2g carbohydrate, 0.3g fat, 23g protein) plus, according to the situations, either: 90g sucrose, HCB); 6g aspartame; 40g vegetable oil; 40g paraffin oil. Therefore two breakfast will have the same energy content (2072kJ - 495kcal), as did the other two(565 kJ - 135kcal). | Behavioural | – |
Primary outcome
Respiratory quotient
Time frame: 6 months
Respiratory quotient is the ratio of CO2 production on oxygen consumption measured in the expiratory flow
3 secondary outcomes
food liking
Time frame: 6 months
food wanting
Time frame: 6 months
food consumption
Time frame: 6 months
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 24 Aug 2017.
- Derived from this study: PubMed 21795442Brondel L, Landais L, Romer MA, Holley A, Penicaud L. Substrate oxidation influences liking, wanting, macronutrient selection, and consumption of food in humans. Am J Clin Nutr. 2011 Sep;94(3):775-83. doi: 10.3945/ajcn.111.017319. Epub 2011 Jul 27.
- Individual participant dataSharing planned: No
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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.
Luc Penicaud, MD study director
Centre National de la Recherche Scientifique, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food preloads in people with Obesity, run by University of Burgundy 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 5 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: finished, as of the sponsor's last update on 24 Aug 2017. 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?
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?
Respiratory quotient (time frame: 6 months). 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 NCT01122082, which also lists 1 linked publication.
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 24 Aug 2017.