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The Effects of Methylphenidate on Energy Intake and Energy Expenditure

NCT02754258 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-08-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

MPH

60 days on oral methylphenidate administered 2 times daily before lunch and supper.

DRUG

Placebo

60 days on oral placebo administered 2 times daily before lunch and supper

Sponsors & Collaborators

  • University of Ottawa

    collaborator OTHER

  • Children's Hospital of Eastern Ontario

    lead OTHER

Principal Investigators

  • Eric Doucet, PhD · University of Ottawa

  • Philippe Robaey, MD, FRCPC · Childrens Hospital of Eastern Ontario-Research Inst

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-08-31
Completion
2018-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02754258 on ClinicalTrials.gov