Obesity Clinical Trial
Official title:
Clinical Evaluation to Improve Obesity Intervention Prescription: Functional Foods as a Potential Solution for Individuals With a Low Satiety Quotient Phenotype?
Verified date | April 2017 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | September 30, 2008 |
Est. primary completion date | September 30, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 30 Years to 50 Years |
Eligibility |
Inclusion Criteria: - aged between 30 and 50 years - obese (BMI between 30 and 40 kg/m2) - overall good health Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Laval Hospital | Quebec | |
Canada | Laval University | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Canadian Institutes of Health Research (CIHR) |
Canada,
Drapeau V, Blundell J, Gallant AR, Arguin H, Després 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. — View Citation
Filiatrault 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:e140. doi: 10.1038/nutd.2014.37. — View Citation
McNeil 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline body weight at 16 weeks | Body weight (kg) | Pre (Week 0)- and post-intervention (after 16 weeks) | |
Primary | 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) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline BMI at 16 weeks | kg/m2 | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline waist circumference at 16 weeks | cm | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline resting blood pressure at 16 weeks | mmHg | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline resting heart rate at 16 weeks | beat/min | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline resting energy expenditure at 16 weeks | kcal/day | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fat mass at 16 weeks | kg | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline lean body mass at 16 weeks | kg | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline percent fat mass at 16 weeks | percent (%) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline spontaneous energy intake at 16 weeks | Measured following an ad-libitum buffet-type meal (kcal) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline daily energy intake at 16 weeks | Three-day dietary record (kcal/day) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline diet quality (macronutrient composition) at 16 weeks | Three-day dietary record (% carbohydrates, proteins and lipids) | Pre- and post-intervention (week 0 and 16) | |
Secondary | 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). | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline binge eating tendencies at 16 weeks | Binge Eating Scale (possible score between 0-46) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline distress-related body esteem at 16 weeks | Body Esteem Scale (possible score between 0-92) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline cognitive restraint at 16 weeks | Three Factor Eating Questionnaire (possible score between 0-21) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline flexible restraint at 16 weeks | Three Factor Eating Questionnaire (possible score between 0-7) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline rigid restraint at 16 weeks | Three Factor Eating Questionnaire (possible score between 0-7) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline disinhibition at 16 weeks | Three Factor Eating Questionnaire (possible score between 0-16) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline susceptibility for hunger at 16 weeks | Three Factor Eating Questionnaire (possible score between 0-14) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline depression symptoms at 16 weeks | Beck Depression Inventory (possible score between 0-63) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline anxiety symptoms at 16 weeks | State-Trait Anxiety Inventory (possible score between 20-80) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline level of stress at 16 weeks | Perceived Stress Scale (possible score between 0-40) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline sleeping quality at 16 weeks | Pittsburgh Sleep Quality (possible score between 0-21) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood glucose at 16 weeks | mmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood insulin at 16 weeks | mmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood leptin at 16 weeks | ng/ml | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood cortisol at 16 weeks | nmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood total cholesterol at 16 weeks | mmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood HDL-cholesterol at 16 weeks | mmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood LDL-cholesterol at 16 weeks | mmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood phospholipids at 16 weeks | mmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood triglycerides at 16 weeks | mmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood LDL-apolipoprotein at 16 weeks | mmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood free T4 at 16 weeks | nmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline fasting blood total T3 at 16 weeks | nmol/L | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline awakening cortisol response at 16 weeks (T0) | Determined from salivary samples taken at the time of awakening (ug/dl) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline awakening cortisol response at 16 weeks (T15min) | Determined from salivary samples taken 15 minutes after the awakening (ug/dl) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline awakening cortisol response at 16 weeks (T30min) | Determined from salivary samples taken 30 minutes after the awakening (ug/dl) | Pre- and post-intervention (week 0 and 16) | |
Secondary | Change from baseline awakening cortisol response at 16 weeks (T60min) | Determined from salivary samples taken 60 minutes after the awakening (ug/dl) | Pre- and post-intervention (week 0 and 16) |
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