The Effects of Methylphenidate on Energy Intake and Energy Expenditure (MPH)
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|ClinicalTrials.gov Identifier: NCT02754258|
Recruitment Status : Unknown
Verified August 2017 by Phillippe Robaey, Children's Hospital of Eastern Ontario.
Recruitment status was: Recruiting
First Posted : April 28, 2016
Last Update Posted : August 3, 2017
The Problem: Obesity is one of the leading causes of chronic disease and death. The efficacy of diet and exercise to sustain weight loss over the long term is weak. While pharmacotherapy is more effective than behavior intervention in maintaining weight loss the effects are often not sufficient to achieve optimal health benefits. Current drug treatments may be sub-optimal because they do not directly target the rewarding value of food, drive to eat, food liking, and impulsivity for eating energy dense snack foods, all of which influences both quantity and quality of food intake and impacts adherence needed to maintain weight loss.
The Solution: The limitations in current anti-obesity agents are potentially addressed by Methylphenidate (MPH). We showed that MPH reduces food intake, dietary fat intake, hunger and food reward, as increase resting energy expenditure in obese and non-obese adults;however, no controlled field trials have been conducted in obese individuals without ADHD.
Objectives/Hypotheses: Primary: To test the effects of MPH on energy intake in obese men and women. Secondary: to examine the effects of MPH on energy expenditure, body weight, impulsivity, food reward, and olfaction. The investigators predict that compared to placebo, MPH will show reduced appetite, along with reduced impulsivity, food reward, and smell function.
Deliverable: This study may be the first to establish the short-term efficacy and safety of using MPH for weight loss, and if successful, data will inform a larger trial that can potentially identify MPH as a novel therapeutic agent for treating obesity and related chronic diseases in a predisposed population.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: MPH Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Methylphenidate on the Reduction of Food Energy Intake and on the Augmentation of Energy Expenditure|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Placebo Comparator: Placebo
60 day oral administration of sugar placebo twice per day before lunch and supper.
60 days on oral placebo administered 2 times daily before lunch and supper
Other Name: Sugar Placebo
Experimental: Methylphenidate (MPH)
60 day oral administration of active study drug (methylphenidate) twice per day before lunch and supper.
60 days on oral methylphenidate administered 2 times daily before lunch and supper.
Other Name: pms-Methylphenidate
- Change in Energy Intake [ Time Frame: Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit). ]Participant will be offered a lunch buffet that includes items they indicate are preferred. They will be able to eat as much or as little as they choose.
- Change in Energy Expenditure [ Time Frame: Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit). ]Indirect calorimetry measure: participant lies supine on a bed while a neoprene mask is attached to their face. Expired breath is captured by the metabolic cart to assess resting energy expenditure and the thermic effect of feeding.
- Change in Body Weight [ Time Frame: Measured two times over the course of 2 months (once at baseline & once at final visit). ]Participant stands on a weight scale.
- Height [ Time Frame: Measured at baseline. ]Participant stands next to a stadiometer; height will be used to determine BMI at baseline.
- Height [ Time Frame: Measured at final visit; height will be used to determine BMI at the final visit. ]Participant stands next to a stadiometer
- Change in Body Mass Index [ Time Frame: Measured two times over the course of 2 months (once at baseline & once at final visit). ]This measure is a conglomerate of body weight (kg) divided by height (meters squared)
- Change in Impulsivity towards food and non-food reward as measured by reaction time on a computer task. [ Time Frame: Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit). ]A "go/no-go"computer task that measures reaction time to food and non-food cues with simple button-presses on a keyboard.
- Change in Odour Detection Threshold measured with Sniffin' Sticks Odourized Pens [ Time Frame: Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit). ]Odourized pens, called Sniffin Sticks, are used to measure odour detection threshold for a non-toxic odourant called n-butanol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754258
|Contact: Jameason D Cameron, PhD||613-737-7600 ext firstname.lastname@example.org|
|Contact: Gary S Goldfield, PhD||613-737-7600 ext email@example.com|
|Children's Hospital Of Eastern Ontario Research Institute||Recruiting|
|Ottawa, Ontario, Canada, K1H8L1|
|Contact: Children's Hospital Of E Ontario, PhD 6137377600 ext 4103 firstname.lastname@example.org|
|University of Ottawa||Recruiting|
|Ottawa, Ontario, Canada, K1N6N5|
|Contact: Jameason Cameron, PhD 16137377600 ext 4103 email@example.com|
|Study Chair:||Eric Doucet, PhD||University of Ottawa|
|Principal Investigator:||Philippe Robaey, MD, FRCPC||Childrens Hospital of Eastern Ontario-Research Inst|