ObesityNCT03128697
Impact of a Satiating Diet in Obese Men With a Low Satiety Phenotype
A study testing Satiating diet in people with Obesity and Appetite Disorders, run by Laval University at 2 sites in Canada.
Trial summary
The global research project was organized as a clinical process starting with an evaluation aiming at the determination of a diagnosis pertaining to the degree of satiety signal capacity. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Appetite Disorders
- What is being tested?
- Satiating diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2004to 30 Sep 2008
- 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 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 30 and 50 years
- obese (BMI between 30 and 40 kg/m2)
- overall good health
Who cannot join
- Participants taking medication which could influence appetite sensations (hormones, tranquillizers such as chlorpromazine and benzodiazepin, lithium carbonate for bipolar disorders, cyproheptadine, antihistaminic, serotonin antagonist, sulfonylurea and glucocorticoids)
- Type 2 diabetic patients treated with insulin
- Large body weight fluctuations (>4 kg over the last two months)
- High level of restraint behaviour (score > 10 as measured with the Three Factor Eating Questionnaire)
- Performing more than 3 x 30 minutes/week of physical activity.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Clinical Evaluation to Improve Obesity Intervention Prescription: Functional Foods as a Potential Solution for Individuals With a Low Satiety Quotient Phenotype?
The global research project was organized as a clinical process starting with an evaluation aiming at the determination of a diagnosis pertaining to the degree of satiety signal capacity. It was extended by a phase of metabolic and behavioural characterization to better understand the clinical condition of the patients. The main part of the program was a weight loss intervention that was focused on high satiating foods. Finally, the process was completed by an evaluation allowing to determine the impact of the intervention on the metabolic and behavioural conditions of the patients.
Read the detailed description
Dietary restriction, being prescribed as low and very low calorie diets, has been largely used as a strategy of dietary management of obesity. Beyond the fact that these diets fully respect the first law of thermodynamics, they are also rather easy to supervise and they offer a guarantee of substantial weight loss to compliant patients. Dietary restriction strategies also carry important limitations which include their failure to take into account appetite sensations of the obese patient. This point is important since it dictates the extent to which the patient can tolerate his/her dietary regimen without hunger over time as well as its related body weight loss. In this regard, experimental and clinical data show that weight regain up to initial body weight and even more occurs over years after a diet-induced weight loss. Moreover, evidence also revealed that restraint behaviour is difficult to maintain over time and that a decrease in this behaviour is related to weight gain on a long term basis. The challenge thus becomes the search of a strategy that can promote a substantial spontaneous energy deficit without significantly altering hunger and satiety levels as well as their related well-being. Up to now, the only approach which emerges as having the potential to respect these two criteria is the design of functional foods, i.e. foods with sufficient satiety-promoting properties to compensate for the enhancing effect of body fat loss on appetite. The food specialists can rely on a catalogue of functional ingredients that can be used to prepare functional menus in order to improve the regulation of energy balance and body weight stability in individuals prone to obesity. As described above, this issue would be particularly relevant for obese individuals displaying a low satiety phenotype, i.e. individuals experiencing difficulty to match energy intake to expenditure in a context promoting excess food intake.
The objectives of this study were to characterize obese men displaying the low satiety phenotype (metabolic and behavioral characteristics) and to determine the impact of highly satiating foods on body weight loss, satiety feelings and compliance in this population.
EXPERIMENTAL DESIGN
Recruitment of subjects and satiety phenotype determination
Each patient referred by a physician was contacted by phone and a first screening interview was performed to validate the inclusion criteria. After recruitment, every subject was met to read and sign the letter of consent as well as to discuss every aspect of the program about which he might have some questions. We took advantage of this brief meeting to measure height, body weight and waist circumference to determine BMI and to estimate the level of abdominal fat.
This phase also included a 2-hour session of evaluation in order to determine satiety signal capacity (SQ). At the end of this session, each subject completed the Three-Factor Eating Questionnaire with the specific preoccupation to measure cognitive dietary restraint as an exclusion criterion. The information collected in this first phase of testing was used to subsequently classify subjects on the basis of their satiety signal capacity (low SQ vs normal/high SQ). Subjects not selected to participate in the next phase of the project received, in addition to their health report, a free dietary consultation focusing on the adoption of healthy behaviours. This first phase of testing allowed to rank order subjects on the basis of their score obtained with the satiety quotient. Seventy participants were selected to participate in the study
Initial metabolic and behavioural characterization (Time 0)
This phase of testing began by a standard medical examination performed by the physician of our research team several days before the main testing session. This permitted to identify potential illnesses influencing appetite control and to evaluate the general health condition of each subject. In order to evaluate the reproducibility over time of the satiety quotient determination and to ascertain the status of subjects determined at the initial evaluation, the standardized breakfast test meal was repeated. However, this test was performed in a session of longer duration that allowed to characterize metabolic and behavioural factors associated with a low/high satiety capacity. The measurements included in this phase of testing were used as baseline measurements for the next phase of this project.
Intervention study
The 70 participants were randomly assigned to either a weight loss program consisting of a highly satiating diet (n=35) (low to moderate in fat (30-35%), high in fibres (> 25g/day), high protein (20-25% of total energy intake) and including 45-50% energy as carbohydrate mainly provided by foods with low glycemic index and adequate to slightly increased vitamin and mineral intakes) which is expected to induce a spontaneous energy deficit or a diet supervision based on the guidelines concordant with the Canadian Food Guide (n=35) (10-15, 55-60 and 30% energy as protein, carbohydrate, and lipid, respectively). For statistical analysis, 4 subgroups have been created based on the SQ classification: 1) low SQ, high satiating diet 2) low SQ, conventional healthy diet, 3) normal/high SQ, high satiating diet, 4) normal/high SQ, conventional healthy diet. This experimental environment thus corresponded to a two by two factorial design in which the two independent variables are SQ and diet. Participants were encouraged to comply with the diets for a 16-week period even if a resistance to weight loss (i.e weight maintenance during one month) was observed during the protocol.
Final metabolic and behavioural characterization (Post-tests; week 16)
All the measurements performed at Time 0 were repeated immediately after the 16-week intervention period for each of the four subgroups of subjects.
POTENTIAL OUTCOME AND FUTURE PERSPECTIVES
The main conceptual outcomes of this were: 1) the characterization of factors implicated in different satiety signal capacities; 2) the investigation of the role of individual capacity of satiety signal in body weight loss and diet compliance, and 3) the determination of the impact of functional menus promoting satiety to compensate for the low spontaneous satiety level in some obese individuals. In addition, this project provided clinical and economical outcomes. Indeed, it represented the first study documenting the weight-reducing impact of a healthy diet based on foods whose functionality have been upgraded by food design. If this project confirms that such a diet can promote weight loss without restriction, but while rather being associated with well-being, this will be a major gain for clinical nutritionists who have up to now unsuccessfully try to counteract the obesity epidemic and who have to deal with consumers who primarily request palatable foods instead of a priori focusing on healthy food. From an economical standpoint, this program will be a reference source of validation for the industry seeking justifications and claims to promote healthy foods facilitating body weight control.
- Conditions
- Obesity, Appetite Disorders
- Being tested
- Satiating diet, Control diet
- Keywords
- Obesity, Satiety quotient, Appetite control, Weight loss, Satiety phenotype, Functional food
- Medical subject headings
- Obesity, Feeding and Eating Disorders, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satiating dietBehavioural
Control dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Satiating diet-Low satiety phenotype | Experimental | Low satiety phenotype subjects who were submitted to the experimental diet (satiating diet) for a 16-week period. Receives: Behavioral: Satiating diet |
| Satiating diet-High satiety phenotype | Experimental | High satiety phenotype subjects who were submitted to the experimental diet (satiating diet) for a 16-week period. Receives: Behavioral: Satiating diet |
| Control diet-Low satiety phenotype | Active comparator | Low satiety phenotype subjects who were submitted to the control diet (based on the Canadian Food Guide) for a 16-week period. Receives: Behavioral: Control diet |
| Control diet-High satiety phenotype | Active comparator | High satiety phenotype subjects who were submitted to the control diet (based on the Canadian Food Guide) for a 16-week period. Receives: Behavioral: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body weight at 16 weeks
Body weight (kg)
Measured: Pre (Week 0)- and post-intervention (after 16 weeks)
Change from baseline satiety responsiveness (satiety quotients) at 16 weeks
Measured by a standardized breakfast test meal using visual analogue scales for 4 appetite sensations (hunger, desire to eat, fullness and prospective food consumption) (mm/100kcal)
Measured: Pre- and post-intervention (week 0 and 16)
Secondary outcomes (39)
Change from baseline BMI at 16 weeks
kg/m2
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline waist circumference at 16 weeks
cm
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline resting blood pressure at 16 weeks
mmHg
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline resting heart rate at 16 weeks
beat/min
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline resting energy expenditure at 16 weeks
kcal/day
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fat mass at 16 weeks
kg
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline lean body mass at 16 weeks
kg
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline percent fat mass at 16 weeks
percent (%)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline spontaneous energy intake at 16 weeks
Measured following an ad-libitum buffet-type meal (kcal)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline daily energy intake at 16 weeks
Three-day dietary record (kcal/day)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline diet quality (macronutrient composition) at 16 weeks
Three-day dietary record (% carbohydrates, proteins and lipids)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline appetite sensations at 16 weeks (desire to eat, fullness, hunger and prospective food consumption)
Measured following an ad-libitum buffet-type meal (0-150 mm).
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline binge eating tendencies at 16 weeks
Binge Eating Scale (possible score between 0-46)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline distress-related body esteem at 16 weeks
Body Esteem Scale (possible score between 0-92)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline cognitive restraint at 16 weeks
Three Factor Eating Questionnaire (possible score between 0-21)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline flexible restraint at 16 weeks
Three Factor Eating Questionnaire (possible score between 0-7)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline rigid restraint at 16 weeks
Three Factor Eating Questionnaire (possible score between 0-7)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline disinhibition at 16 weeks
Three Factor Eating Questionnaire (possible score between 0-16)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline susceptibility for hunger at 16 weeks
Three Factor Eating Questionnaire (possible score between 0-14)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline depression symptoms at 16 weeks
Beck Depression Inventory (possible score between 0-63)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline anxiety symptoms at 16 weeks
State-Trait Anxiety Inventory (possible score between 20-80)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline level of stress at 16 weeks
Perceived Stress Scale (possible score between 0-40)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline sleeping quality at 16 weeks
Pittsburgh Sleep Quality (possible score between 0-21)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood glucose at 16 weeks
mmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood insulin at 16 weeks
mmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood leptin at 16 weeks
ng/ml
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood cortisol at 16 weeks
nmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood total cholesterol at 16 weeks
mmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood HDL-cholesterol at 16 weeks
mmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood LDL-cholesterol at 16 weeks
mmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood phospholipids at 16 weeks
mmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood triglycerides at 16 weeks
mmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood LDL-apolipoprotein at 16 weeks
mmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood free T4 at 16 weeks
nmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood total T3 at 16 weeks
nmol/L
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline awakening cortisol response at 16 weeks (T0)
Determined from salivary samples taken at the time of awakening (ug/dl)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline awakening cortisol response at 16 weeks (T15min)
Determined from salivary samples taken 15 minutes after the awakening (ug/dl)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline awakening cortisol response at 16 weeks (T30min)
Determined from salivary samples taken 30 minutes after the awakening (ug/dl)
Measured: Pre- and post-intervention (week 0 and 16)
Change from baseline awakening cortisol response at 16 weeks (T60min)
Determined from salivary samples taken 60 minutes after the awakening (ug/dl)
Measured: Pre- and post-intervention (week 0 and 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Oct 2004
- Primary completion30 Sep 2008
- Study completion30 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Angelo Tremblay, Laval University
- Investigators
- Angelo Tremblay, PhD, Principal investigator, Laval UniversityDrapeau Vicky, PhD, Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128697
- Sponsor's protocol ID
- MOP-68858
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drapeau V, Blundell J, Gallant AR, Arguin H, Despres JP, Lamarche B, Tremblay A. Behavioural and metabolic characterisation of the low satiety phenotype. Appetite. 2013 Nov;70:67-72. doi: 10.1016/j.appet.2013.05.022. Epub 2013 Jun 20.
PubMed 23792908Filiatrault ML, Chaput JP, Drapeau V, Tremblay A. Eating behavior traits and sleep as determinants of weight loss in overweight and obese adults. Nutr Diabetes. 2014 Oct 20;4(10):e140. doi: 10.1038/nutd.2014.37.
PubMed 25329602McNeil J, Drapeau V, Gallant AR, Tremblay A, Doucet E, Chaput JP. Short sleep duration is associated with a lower mean satiety quotient in overweight and obese men. Eur J Clin Nutr. 2013 Dec;67(12):1328-30. doi: 10.1038/ejcn.2013.204. Epub 2013 Oct 16.
PubMed 24129360
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation to Improve Obesity Intervention Prescription: Functional Foods as a Potential Solution for Individuals With a Low Satiety Quotient Phenotype?
- ClinicalTrials.gov ID
- NCT03128697
- Acronym / sponsor ID
- MOP-68858
- Conditions
- Obesity, Appetite Disorders
- Keywords
- Obesity, Satiety quotient, Appetite control, Weight loss, Satiety phenotype, Functional food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Oct 2004 (actual)
- Primary completion
- 30 Sep 2008 (actual)
- Study completion
- 30 Sep 2008 (actual)
- First posted
- 25 Apr 2017 (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 global research project was organized as a clinical process starting with an evaluation aiming at the determination of a diagnosis pertaining to the degree of satiety signal capacity. It was extended by a phase of metabolic and behavioural characterization to better understand the clinical condition of the patients. The main part of the program was a weight loss intervention that was focused on high satiating foods. Finally, the process was completed by an evaluation allowing to determine the impact of the intervention on the metabolic and behavioural conditions of the patients.
Detailed description
Dietary restriction, being prescribed as low and very low calorie diets, has been largely used as a strategy of dietary management of obesity. Beyond the fact that these diets fully respect the first law of thermodynamics, they are also rather easy to supervise and they offer a guarantee of substantial weight loss to compliant patients. Dietary restriction strategies also carry important limitations which include their failure to take into account appetite sensations of the obese patient. This point is important since it dictates the extent to which the patient can tolerate his/her dietary regimen without hunger over time as well as its related body weight loss. In this regard, experimental and clinical data show that weight regain up to initial body weight and even more occurs over years after a diet-induced weight loss. Moreover, evidence also revealed that restraint behaviour is difficult to maintain over time and that a decrease in this behaviour is related to weight gain on a long term basis. The challenge thus becomes the search of a strategy that can promote a substantial spontaneous energy deficit without significantly altering hunger and satiety levels as well as their related well-being. Up to now, the only approach which emerges as having the potential to respect these two criteria is the design of functional foods, i.e. foods with sufficient satiety-promoting properties to compensate for the enhancing effect of body fat loss on appetite. The food specialists can rely on a catalogue of functional ingredients that can be used to prepare functional menus in order to improve the regulation of energy balance and body weight stability in individuals prone to obesity. As described above, this issue would be particularly relevant for obese individuals displaying a low satiety phenotype, i.e. individuals experiencing difficulty to match energy intake to expenditure in a context promoting excess food intake.
The objectives of this study were to characterize obese men displaying the low satiety phenotype (metabolic and behavioral characteristics) and to determine the impact of highly satiating foods on body weight loss, satiety feelings and compliance in this population.
EXPERIMENTAL DESIGN
Recruitment of subjects and satiety phenotype determination
Each patient referred by a physician was contacted by phone and a first screening interview was performed to validate the inclusion criteria. After recruitment, every subject was met to read and sign the letter of consent as well as to discuss every aspect of the program about which he might have some questions. We took advantage of this brief meeting to measure height, body weight and waist circumference to determine BMI and to estimate the level of abdominal fat.
This phase also included a 2-hour session of evaluation in order to determine satiety signal capacity (SQ). At the end of this session, each subject completed the Three-Factor Eating Questionnaire with the specific preoccupation to measure cognitive dietary restraint as an exclusion criterion. The information collected in this first phase of testing was used to subsequently classify subjects on the basis of their satiety signal capacity (low SQ vs normal/high SQ). Subjects not selected to participate in the next phase of the project received, in addition to their health report, a free dietary consultation focusing on the adoption of healthy behaviours. This first phase of testing allowed to rank order subjects on the basis of their score obtained with the satiety quotient. Seventy participants were selected to participate in the study
Initial metabolic and behavioural characterization (Time 0)
This phase of testing began by a standard medical examination performed by the physician of our research team several days before the main testing session. This permitted to identify potential illnesses influencing appetite control and to evaluate the general health condition of each subject. In order to evaluate the reproducibility over time of the satiety quotient determination and to ascertain the status of subjects determined at the initial evaluation, the standardized breakfast test meal was repeated. However, this test was performed in a session of longer duration that allowed to characterize metabolic and behavioural factors associated with a low/high satiety capacity. The measurements included in this phase of testing were used as baseline measurements for the next phase of this project.
Intervention study
The 70 participants were randomly assigned to either a weight loss program consisting of a highly satiating diet (n=35) (low to moderate in fat (30-35%), high in fibres (> 25g/day), high protein (20-25% of total energy intake) and including 45-50% energy as carbohydrate mainly provided by foods with low glycemic index and adequate to slightly increased vitamin and mineral intakes) which is expected to induce a spontaneous energy deficit or a diet supervision based on the guidelines concordant with the Canadian Food Guide (n=35) (10-15, 55-60 and 30% energy as protein, carbohydrate, and lipid, respectively). For statistical analysis, 4 subgroups have been created based on the SQ classification: 1) low SQ, high satiating diet 2) low SQ, conventional healthy diet, 3) normal/high SQ, high satiating diet, 4) normal/high SQ, conventional healthy diet. This experimental environment thus corresponded to a two by two factorial design in which the two independent variables are SQ and diet. Participants were encouraged to comply with the diets for a 16-week period even if a resistance to weight loss (i.e weight maintenance during one month) was observed during the protocol.
Final metabolic and behavioural characterization (Post-tests; week 16)
All the measurements performed at Time 0 were repeated immediately after the 16-week intervention period for each of the four subgroups of subjects.
POTENTIAL OUTCOME AND FUTURE PERSPECTIVES
The main conceptual outcomes of this were: 1) the characterization of factors implicated in different satiety signal capacities; 2) the investigation of the role of individual capacity of satiety signal in body weight loss and diet compliance, and 3) the determination of the impact of functional menus promoting satiety to compensate for the low spontaneous satiety level in some obese individuals. In addition, this project provided clinical and economical outcomes. Indeed, it represented the first study documenting the weight-reducing impact of a healthy diet based on foods whose functionality have been upgraded by food design. If this project confirms that such a diet can promote weight loss without restriction, but while rather being associated with well-being, this will be a major gain for clinical nutritionists who have up to now unsuccessfully try to counteract the obesity epidemic and who have to deal with consumers who primarily request palatable foods instead of a priori focusing on healthy food. From an economical standpoint, this program will be a reference source of validation for the industry seeking justifications and claims to promote healthy foods facilitating body weight control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Satiating diet-Low satiety phenotype | Experimental | Behavioral: Satiating dietLow satiety phenotype subjects who were submitted to the experimental diet (satiating diet) for a 16-week period. |
| Satiating diet-High satiety phenotype | Experimental | Behavioral: Satiating dietHigh satiety phenotype subjects who were submitted to the experimental diet (satiating diet) for a 16-week period. |
| Control diet-Low satiety phenotype | Active comparator | Behavioral: Control dietLow satiety phenotype subjects who were submitted to the control diet (based on the Canadian Food Guide) for a 16-week period. |
| Control diet-High satiety phenotype | Active comparator | Behavioral: Control dietHigh satiety phenotype subjects who were submitted to the control diet (based on the Canadian Food Guide) for a 16-week period. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged between 30 and 50 years
- obese (BMI between 30 and 40 kg/m2)
- overall good health
Key exclusion criteria (5 listed)
- Participants taking medication which could influence appetite sensations (hormones, tranquillizers such as chlorpromazine and benzodiazepin, lithium carbonate for bipolar disorders, cyproheptadine, antihistaminic, serotonin antagonist, sulfonylurea and glucocorticoids)
- Type 2 diabetic patients treated with insulin
- Large body weight fluctuations (>4 kg over the last two months)
- High level of restraint behaviour (score > 10 as measured with the Three Factor Eating Questionnaire)
- Performing more than 3 x 30 minutes/week of physical activity.
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 |
|---|---|---|
| Satiating diet | Behavioural | Satiating diet-High satiety phenotype, Satiating diet-Low satiety phenotype |
| Control diet | Behavioural | Control diet-High satiety phenotype, Control diet-Low satiety phenotype |
Primary outcome
Change from baseline body weight at 16 weeks
Time frame: Pre (Week 0)- and post-intervention (after 16 weeks)
Body weight (kg)
Change from baseline satiety responsiveness (satiety quotients) at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Measured by a standardized breakfast test meal using visual analogue scales for 4 appetite sensations (hunger, desire to eat, fullness and prospective food consumption) (mm/100kcal)
39 secondary outcomes
Change from baseline BMI at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline waist circumference at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline resting blood pressure at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline resting heart rate at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline resting energy expenditure at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fat mass at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline lean body mass at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline percent fat mass at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline spontaneous energy intake at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline daily energy intake at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline diet quality (macronutrient composition) at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline appetite sensations at 16 weeks (desire to eat, fullness, hunger and prospective food consumption)
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline binge eating tendencies at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline distress-related body esteem at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline cognitive restraint at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline flexible restraint at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline rigid restraint at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline disinhibition at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline susceptibility for hunger at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline depression symptoms at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline anxiety symptoms at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline level of stress at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline sleeping quality at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood glucose at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood insulin at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood leptin at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood cortisol at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood total cholesterol at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood HDL-cholesterol at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood LDL-cholesterol at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood phospholipids at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood triglycerides at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood LDL-apolipoprotein at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood free T4 at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline fasting blood total T3 at 16 weeks
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline awakening cortisol response at 16 weeks (T0)
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline awakening cortisol response at 16 weeks (T15min)
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline awakening cortisol response at 16 weeks (T30min)
Time frame: Pre- and post-intervention (week 0 and 16)
Change from baseline awakening cortisol response at 16 weeks (T60min)
Time frame: Pre- and post-intervention (week 0 and 16)
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 26 Apr 2017.
- Results publication: PubMed 23792908Drapeau V, Blundell J, Gallant AR, Arguin H, Despres JP, Lamarche B, Tremblay A. Behavioural and metabolic characterisation of the low satiety phenotype. Appetite. 2013 Nov;70:67-72. doi: 10.1016/j.appet.2013.05.022. Epub 2013 Jun 20.
- Results publication: PubMed 25329602Filiatrault ML, Chaput JP, Drapeau V, Tremblay A. Eating behavior traits and sleep as determinants of weight loss in overweight and obese adults. Nutr Diabetes. 2014 Oct 20;4(10):e140. doi: 10.1038/nutd.2014.37.
- Results publication: PubMed 24129360McNeil J, Drapeau V, Gallant AR, Tremblay A, Doucet E, Chaput JP. Short sleep duration is associated with a lower mean satiety quotient in overweight and obese men. Eur J Clin Nutr. 2013 Dec;67(12):1328-30. doi: 10.1038/ejcn.2013.204. Epub 2013 Oct 16.
- 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.
Angelo Tremblay, PhD principal investigator
Laval University
Drapeau Vicky, PhD study director
Laval University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Satiating diet in people with Obesity and Appetite Disorders, run by Laval University at 2 sites in Canada.
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 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: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Change from baseline body weight at 16 weeks (time frame: Pre (Week 0)- and post-intervention (after 16 weeks)). The study lists 2 primary outcomes in all. 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 NCT03128697, which also lists 3 linked publications.
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 26 Apr 2017.