VolunteersSAFRANNCT01573988
Satiety, Meal Frequency and Nutritional Aspects
A study testing Increasing eating frequency in people with Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Volunteers
- What is being tested?
- Increasing eating frequency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2010to Apr 2012
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No smokers
- BMI 20 to 35 kg/m2
- Moderate physical activity
- Safety during medical consultation
- Feeding behavioural phenotype (Dutch Eating Questionnaire, Three Eating Factor Questionnaire)
Who cannot join
- Medical history which may affect glucose metabolism (diabetes, renal or hepatic failure, thyroid dysfunction, Cushing syndrome, acromegaly…)
- Medical history which affect nutrient absorption (gastro-intestinal and pancreatic disease, gastrectomy, colectomy…)
- Drug use in the last two months that could affect glucose metabolism (steroids, topical gastric preparation, anorectic drugs…)
- Eating disorders
- Claustrophobic subjects
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Lyon Sud - Centre de Recherche en Nutrition Humaine
Pierre-Bénite, 69495
About this study
Official title: Behavioural and Metabolic Consequences of Increasing Eating Frequency
In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese subjects through :
- the physiological consequences : difference in postprandial kinetics of glucose, non esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin, ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1 (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA), glutathion, lipid hydroperoxides)
- eating behavior during an ad libitum buffet test meal
- Conditions
- Volunteers
- Being tested
- Increasing eating frequency
- Keywords
- Nutrition, Eating frequency, Food intake, Eating behavior, Satiety, Ghrelin
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing eating frequencyOther
The subjects receive the same breakfast with two sequences :
- breakfast in one intake at 8:00
- breakfast in four isocaloric intakes (8:00, 9:00, 10:00, 11:00) The sequence made twice : one for metabolic study and one for the study of eating behavior
The lunch during metabolic study is a standard meal The lunch during behavioural study is an ad libitum buffet test meal.
The administration order is determined by randomized allocation. The wash-out period is one to three weeks.
There are not diet or exercise interventions.
| Study group | Role | What they receive |
|---|---|---|
| non-obese volunteers | Other | Volunteers with a BMI (Body Mass Index) between 20 and 25 kg/m2. Receives: Other: Increasing eating frequency |
| Obese volunteers | Other | Volunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2. Receives: Other: Increasing eating frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin plasmatic concentration
Measured: 240 minutes after breakfast beginning (just before the lunch)
Secondary outcomes (7)
Satiety through food intakes (quantitative) at the ad libitum buffet test meal
Measured: Since the beginning of the buffet test meal (240 minutes after breakfast beginning) to the end of the meal (at the latest 270 minutes after breakfast beginning).
Satiety through visual analogue scale
Measured: 240 minutes after breakfast beginning (just before the lunch)
Plasma metabolite concentrations (glycaemia, non esterified fatty acid,
Measured: kinetics during 430 minutes
Endocrine concentrations (insulin, ghrelin, GLP-1, PYY, leptin, C-peptide)
Measured: kinetics during 430 minutes
Plasma markers of oxidative stress (MDA, gluthation, lipid hydroxide)
Measured: kinetics during 430 minutes
Lipid oxidation
Measured: kinetics during 430 minutes
Eating behaviour at the buffet test meal by video recording (food choice, nutritional composition of the meal , kinetics of nutrient intake, meal structure, lunch duration)
Measured: during the buffet test meal (max : 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startAug 2010
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Difficulties in recruiting of volunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573988
- Sponsor's protocol ID
- 2010.612/16
- Acronym
- SAFRAN
- Status last verified
- Sep 2012
- First submitted
- 4 Apr 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural and Metabolic Consequences of Increasing Eating Frequency
- ClinicalTrials.gov ID
- NCT01573988
- Acronym / sponsor ID
- SAFRAN / 2010.612/16
- Conditions
- Volunteers
- Keywords
- Nutrition, Eating frequency, Food intake, Eating behavior, Satiety, Ghrelin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting of volunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Apr 2012 (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.
In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese subjects through :
- the physiological consequences : difference in postprandial kinetics of glucose, non esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin, ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1 (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA), glutathion, lipid hydroperoxides)
- eating behavior during an ad libitum buffet test meal
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-obese volunteers | Other | Other: Increasing eating frequencyVolunteers with a BMI (Body Mass Index) between 20 and 25 kg/m2. |
| Obese volunteers | Other | Other: Increasing eating frequencyVolunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- No smokers
- BMI 20 to 35 kg/m2
- Moderate physical activity
- Safety during medical consultation
- Feeding behavioural phenotype (Dutch Eating Questionnaire, Three Eating Factor Questionnaire)
Key exclusion criteria (5 listed)
- Medical history which may affect glucose metabolism (diabetes, renal or hepatic failure, thyroid dysfunction, Cushing syndrome, acromegaly…)
- Medical history which affect nutrient absorption (gastro-intestinal and pancreatic disease, gastrectomy, colectomy…)
- Drug use in the last two months that could affect glucose metabolism (steroids, topical gastric preparation, anorectic drugs…)
- Eating disorders
- Claustrophobic subjects
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 |
|---|---|---|
| Increasing eating frequencyThe subjects receive the same breakfast with two sequences : * breakfast in one intake at 8:00 * breakfast in four isocaloric intakes (8:00, 9:00, 10:00, 11:00) The sequence made twice : one for metabolic study and one for the study of eating behavior The lunch during metabolic study is a standard meal The lunch during behavioural study is an ad libitum buffet test meal. The administration order is determined by randomized allocation. The wash-out period is one to three weeks. There are not diet or exercise interventions. | Other | Obese volunteers, non-obese volunteers |
Primary outcome
Ghrelin plasmatic concentration
Time frame: 240 minutes after breakfast beginning (just before the lunch)
7 secondary outcomes
Satiety through food intakes (quantitative) at the ad libitum buffet test meal
Time frame: Since the beginning of the buffet test meal (240 minutes after breakfast beginning) to the end of the meal (at the latest 270 minutes after breakfast beginning).
Satiety through visual analogue scale
Time frame: 240 minutes after breakfast beginning (just before the lunch)
Plasma metabolite concentrations (glycaemia, non esterified fatty acid,
Time frame: kinetics during 430 minutes
Endocrine concentrations (insulin, ghrelin, GLP-1, PYY, leptin, C-peptide)
Time frame: kinetics during 430 minutes
Plasma markers of oxidative stress (MDA, gluthation, lipid hydroxide)
Time frame: kinetics during 430 minutes
Lipid oxidation
Time frame: kinetics during 430 minutes
Eating behaviour at the buffet test meal by video recording (food choice, nutritional composition of the meal , kinetics of nutrient intake, meal structure, lunch duration)
Time frame: during the buffet test meal (max : 30 minutes)
Results and safety
The study was stopped early (reason given: Difficulties in recruiting of volunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
- Related InfoLink provided by the sponsor.
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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.
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 Increasing eating frequency in people with Volunteers, run by Hospices Civils de Lyon 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 5 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: stopped early, as of the sponsor's last update on 27 Sep 2012. 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 was stopped early (reason given: Difficulties in recruiting of volunteers with a BMI (Body Mass Index) between 30 and 35 kg/m2). Results are not available in the source record.
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?
Ghrelin plasmatic concentration (time frame: 240 minutes after breakfast beginning (just before the lunch)). 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 27 Sep 2012.