Eating BehaviormCPPNCT03962829
Effect of mCPP on Cognitive Control, Appetite, and Neural Responses
A study testing mCPP in people with Eating Behavior and Obesity, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Previous studies have reported that the 5-HT2C receptor agonist meta-chlorophenylpiperazine (mCPP) decreases appetite and food intake in humans1-3. 5-HT2C receptor activation inhibits dopamine and norepinephrine release in the brain4, and has also been linked to diabetes5. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Obesity
- What is being tested?
- mCPP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 20 Mar 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subjects
- Age 18-65 years at start of the study
- Body Mass Index (BMI) between 18 and 25 kg/m2 for the lean group and between 30 and 40 kg/m2 for the obese group
- Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
- Ability to give informed consent
- Fluent English speaking
- Willingness to be informed about chance findings of pathology
Who cannot join
- Subjects who have a non-removable metal object in or at their body, such as, for example: Heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- Tattoos, that are older than 15 years
- Claustrophobia
- Limited temperature perception and/or increased sensitivity to warming of the body
- Pathological hearing ability or an increased sensitivity to loud noises
- Lack of ability to give informed consent
Show all 20Show fewer
- Operation less than three months ago
- Simultaneous participation in other studies that involve drugs intake or blood spending
- Acute illness or infection during the last 4 weeks
- Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome)
- Moderate or severe head injury
- Eating disorders
- No metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression) or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
- Intake of any medication that can interfere with the drug or measurements.
- Current weight loss regimens, or more then 5kg weight loss in the last 3 months
- Smoking
- Current pregnancy or breastfeeding
- Current or past history of drug or alcohol dependency - alcohol consumption exceeding 12 units a week
- Food allergies (e.g. peanut allergy lactose and gluten intolerance) or vegetarian/vegan diet
- Disliking the study lunch
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham School of Psychology
Birmingham, Midlands, B15 2TT
About this study
Official title: The Effect of Oral Administration of Meta-chlorophenylpiperazine (mCPP) on Cognitive Processes, Appetite, and Related Neural Responses in Healthy Lean and Obese Participants
Previous studies have reported that the 5-HT2C receptor agonist meta-chlorophenylpiperazine (mCPP) decreases appetite and food intake in humans1-3. 5-HT2C receptor activation inhibits dopamine and norepinephrine release in the brain4, and has also been linked to diabetes5. The specificity of the effect of mCPP on human appetite is unclear, as previous studies also reported an increase in nausea1,3. The drug has also been reported to increase anxiety and cause panic attacks when given in a bolus dose intravenously6. Previous findings in our laboratory showed that mCPP reduced appetite, increased satiety in women and enhanced memory in the P1vital® Oxford Emotional Test Battery3. Following up on these results a food intake and fMRI study was performed, in which it was observed that mCPP decreased intake of a palatable snack (hedonic eating) and dlPFC and insula BOLD responses to food pictures. Additionally it increased memory and food value responses in brain after mCPP administration (Thomas et al submitted).
It is well established that eating behaviour is affected by metabolic signals (e.g. insulin, ghrelin, serotonin) and is also modulated via food reward processes7. More recently it has been proposed that eating is also modulated via higher cognitive processes such as inhibitory control, attention, and memory. However, in humans, eating behaviour seems to be a more complex process, which involves habits, long-term goals and social interaction. Thus, cognitive processes appear to play an important role in food consumption. In the proposed study the researchers investigate the effect of administering mCPP, on eating, and on metabolic, reward and cognitive processes and the potential interplay between these functions.
Read the detailed description
The prevalence of overweight and obesity has increased rapidly in less than half a century. It is assumed that this development is due to interplay between behavioural, environmental and genetic factors. This increase in weight is associated with multiple-medical conditions, e.g. increased depression, and chronicle health conditions, like heart disease, cancer, and type 2 diabetes, and is associated with high health care costs. The UK has one of the highest rates of obesity in Europe, with 20% of the population defined as obese and over 50% defined as overweight. However treatment options for weight loss, and especially long-term weight maintenance are still limited. The development of safe and effective therapeutics is therefore imperative. An effective way to help weight loss, as part of a comprehensive program, is to prescribe drug treatments designed to reduce food consumption. However, at present, drug treatments for obesity are very limited.
mCPP appears to reduce food intake, and appetite in lean people. However it also seems to effect cognitive processes. Basic research to understand the interplay between these processes in relation to drug effects on appetite are of great interest because it can provide important insight into new development novel treatments for obesity. The investigators propose to test a model outlining that metabolic signals may reduce food intake by interfering with cognitive processes that underpin appetite.
It has been agreed upon that eating behaviour is affected by metabolic signals, e.g. serotonin, insulin and ghrelin, and influenced by food reward processes (Berthoud 2011). But the idea that these mechanisms are modulated via higher cognitive processes such as inhibitory control, attention, and memory is a relatively new domain to be explored. In humans, eating behaviour seems to be a more complex system; which also involves habits, long-term goals, and social interaction. Cognitive processes appear to play an important role in food consumption. Previous studies reported the anorectic effect of the drugs meta-chloriphenylpiperazine (mCPP), a 5-HT2C receptor agonist. Additionally mCPP has been shown to reduce appetite, increase satiety, and enhance memory for emotional material (word recall) and recognition memory (Thomas et al 2015). Preliminary results suggest that mCPP decreased intake of palatable snacks (hedonic eating) and when viewing food pictures appetite and reward related neural responses appear to be modulated by mCPP administration (Thomas et al in preparation). However the interaction between the drugs, neural responses and behaviour are still not known, and the effects of overweight on these responses is a very interesting question in relation to anti-obesity drug development.
In the proposed study the researchers want to investigate the effect of oral administrating mCPP, on neural responses and networks in relation to food reward, cognitive control and working memory and its impact on subsequent snack consumption, food and emotion related memory, and mood and appetite ratings, and additionally the interplay between all these processes in both lean and obese individuals. Participants will get an mCPP dose (30mg) and a placebo on different occasion, where after the neural activation (with fMRI) in response to food stimuli is assesed, inhibition tasks, and memory tests. This will be related to eating behaviour, memory performance, and mood and appetite ratings.
- Conditions
- Eating Behavior, Obesity
- Being tested
- mCPP, Placebo oral tablet
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCPPDrug
Also called meta-chlorophenylpiperazine
Healthy participants administrate one capsule of mCPP (30mg)
Placebo oral tabletDrug
Healthy participants administrate one capsule of placebo (containing lactose)
| Study group | Role | What they receive |
|---|---|---|
| Placebo condition | Placebo comparator | Participants receive placebo capsule Receives: Drug: Placebo oral tablet |
| mCPP condition | Active comparator | Participants receive active (mCPP) capsule Receives: Drug: mCPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI brain response during food reward processes
Brain responses for food stimuli compared to non-food stimuli. The researchers will measure this by showing subjects food and non-food images while preforming and fMRI-scan and subtract activity during non-food images from the activity pattern when looking at food images.
Measured: 21 min
Secondary outcomes (9)
fMRI brain response during inhibition processes
Neural activation during delay discounting paradigm for both food and monetary reward choices
Measured: 20 min
Emotional categorisation
Accuracy of category and reaction time will be measured for dislike or like words
Measured: 10 min
Emotional recall part 1
Recall words of liked and disliked words will be recorded in ECAT
Measured: 4 min
Emotional recall part 1
Accuracy of previous exposed or not exposed words will be measured
Measured: 10 min
Pasta intake
Amount (kcal and gram) of pasta eaten will be measured
Measured: 20 min
Cookies intake
Amount (kcal and gram) of cookies eaten will be measured
Measured: 10 min
fMRI neural network
Functional connectivity during resting state
Measured: 10 min
VPA
Verbal pair association tasks, correct amount of word pairs remembered
Measured: 20 min
N-back
N-back tasks, measure of working memory and working memory capacity
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Feb 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: due to the Covid 19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- counter-balanced, double-blind, placebo-controlled, crossover, within-subject design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham
- Responsible party
- Sponsor
- Investigators
- Maartje Spetter, PhD, Principal investigator, University fo Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962829
- Sponsor's protocol ID
- RG_16_214
- Acronym
- mCPP
- Status last verified
- Nov 2020
- First submitted
- 22 May 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and data will be shared on Open Science Forum
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Administration of Meta-chlorophenylpiperazine (mCPP) on Cognitive Processes, Appetite, and Related Neural Responses in Healthy Lean and Obese Participants
- ClinicalTrials.gov ID
- NCT03962829
- Acronym / sponsor ID
- mCPP / RG_16_214
- Conditions
- Eating Behavior, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to the Covid 19 pandemic
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University Hospital Birmingham
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 24 May 2019 (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.
Previous studies have reported that the 5-HT2C receptor agonist meta-chlorophenylpiperazine (mCPP) decreases appetite and food intake in humans1-3. 5-HT2C receptor activation inhibits dopamine and norepinephrine release in the brain4, and has also been linked to diabetes5. The specificity of the effect of mCPP on human appetite is unclear, as previous studies also reported an increase in nausea1,3. The drug has also been reported to increase anxiety and cause panic attacks when given in a bolus dose intravenously6. Previous findings in our laboratory showed that mCPP reduced appetite, increased satiety in women and enhanced memory in the P1vital® Oxford Emotional Test Battery3. Following up on these results a food intake and fMRI study was performed, in which it was observed that mCPP decreased intake of a palatable snack (hedonic eating) and dlPFC and insula BOLD responses to food pictures. Additionally it increased memory and food value responses in brain after mCPP administration (Thomas et al submitted).
It is well established that eating behaviour is affected by metabolic signals (e.g. insulin, ghrelin, serotonin) and is also modulated via food reward processes7. More recently it has been proposed that eating is also modulated via higher cognitive processes such as inhibitory control, attention, and memory. However, in humans, eating behaviour seems to be a more complex process, which involves habits, long-term goals and social interaction. Thus, cognitive processes appear to play an important role in food consumption. In the proposed study the researchers investigate the effect of administering mCPP, on eating, and on metabolic, reward and cognitive processes and the potential interplay between these functions.
Detailed description
The prevalence of overweight and obesity has increased rapidly in less than half a century. It is assumed that this development is due to interplay between behavioural, environmental and genetic factors. This increase in weight is associated with multiple-medical conditions, e.g. increased depression, and chronicle health conditions, like heart disease, cancer, and type 2 diabetes, and is associated with high health care costs. The UK has one of the highest rates of obesity in Europe, with 20% of the population defined as obese and over 50% defined as overweight. However treatment options for weight loss, and especially long-term weight maintenance are still limited. The development of safe and effective therapeutics is therefore imperative. An effective way to help weight loss, as part of a comprehensive program, is to prescribe drug treatments designed to reduce food consumption. However, at present, drug treatments for obesity are very limited.
mCPP appears to reduce food intake, and appetite in lean people. However it also seems to effect cognitive processes. Basic research to understand the interplay between these processes in relation to drug effects on appetite are of great interest because it can provide important insight into new development novel treatments for obesity. The investigators propose to test a model outlining that metabolic signals may reduce food intake by interfering with cognitive processes that underpin appetite.
It has been agreed upon that eating behaviour is affected by metabolic signals, e.g. serotonin, insulin and ghrelin, and influenced by food reward processes (Berthoud 2011). But the idea that these mechanisms are modulated via higher cognitive processes such as inhibitory control, attention, and memory is a relatively new domain to be explored. In humans, eating behaviour seems to be a more complex system; which also involves habits, long-term goals, and social interaction. Cognitive processes appear to play an important role in food consumption. Previous studies reported the anorectic effect of the drugs meta-chloriphenylpiperazine (mCPP), a 5-HT2C receptor agonist. Additionally mCPP has been shown to reduce appetite, increase satiety, and enhance memory for emotional material (word recall) and recognition memory (Thomas et al 2015). Preliminary results suggest that mCPP decreased intake of palatable snacks (hedonic eating) and when viewing food pictures appetite and reward related neural responses appear to be modulated by mCPP administration (Thomas et al in preparation). However the interaction between the drugs, neural responses and behaviour are still not known, and the effects of overweight on these responses is a very interesting question in relation to anti-obesity drug development.
In the proposed study the researchers want to investigate the effect of oral administrating mCPP, on neural responses and networks in relation to food reward, cognitive control and working memory and its impact on subsequent snack consumption, food and emotion related memory, and mood and appetite ratings, and additionally the interplay between all these processes in both lean and obese individuals. Participants will get an mCPP dose (30mg) and a placebo on different occasion, where after the neural activation (with fMRI) in response to food stimuli is assesed, inhibition tasks, and memory tests. This will be related to eating behaviour, memory performance, and mood and appetite ratings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- counter-balanced, double-blind, placebo-controlled, crossover, within-subject design
| Arm | Type | Receives |
|---|---|---|
| Placebo condition | Placebo comparator | Drug: Placebo oral tabletParticipants receive placebo capsule |
| mCPP condition | Active comparator | Drug: mCPPParticipants receive active (mCPP) capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy female subjects
- Age 18-65 years at start of the study
- Body Mass Index (BMI) between 18 and 25 kg/m2 for the lean group and between 30 and 40 kg/m2 for the obese group
- Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
- Ability to give informed consent
Key exclusion criteria (20 listed)
- Subjects who have a non-removable metal object in or at their body, such as, for example: Heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- Tattoos, that are older than 15 years
- Claustrophobia
- Limited temperature perception and/or increased sensitivity to warming of the body
- Pathological hearing ability or an increased sensitivity to loud noises
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 |
|---|---|---|
| mCPPAlso: meta-chlorophenylpiperazineHealthy participants administrate one capsule of mCPP (30mg) | Drug | mCPP condition |
| Placebo oral tabletHealthy participants administrate one capsule of placebo (containing lactose) | Drug | Placebo condition |
Primary outcome
fMRI brain response during food reward processes
Time frame: 21 min
Brain responses for food stimuli compared to non-food stimuli. The researchers will measure this by showing subjects food and non-food images while preforming and fMRI-scan and subtract activity during non-food images from the activity pattern when looking at food images.
9 secondary outcomes
fMRI brain response during inhibition processes
Time frame: 20 min
Emotional categorisation
Time frame: 10 min
Emotional recall part 1
Time frame: 4 min
Emotional recall part 1
Time frame: 10 min
Pasta intake
Time frame: 20 min
Cookies intake
Time frame: 10 min
fMRI neural network
Time frame: 10 min
VPA
Time frame: 20 min
N-back
Time frame: 10 min
Results and safety
The study was stopped early (reason given: due to the Covid 19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: Yes. The study protocol and data will be shared on Open Science Forum
Related trials for Eating Behavior
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders
Self-harm Behavior, Eating Disorders
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Enrolling by invitationObservational study
NutFinForce - Lifestyle Performance Medicine Intervention on Defense Performance in Finland
No Condition
Recruiting
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II
Avoidant/Restrictive Food Intake Disorder (ARFID)
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.
Maartje Spetter, PhD principal investigator
University fo Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCPP in people with Eating Behavior and Obesity, run by University of Birmingham at 1 site in United Kingdom.
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 7 inclusion and 20 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 6 Nov 2020. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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: due to the Covid 19 pandemic). 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?
fMRI brain response during food reward processes (time frame: 21 min). 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 6 Nov 2020.