Eating BehaviorEarly Phase 1NCT01513499
Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women
A Early Phase 1 study testing Oxytocin in people with Eating Behavior, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2014
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old
- BMI 18.5-24.9, 25-40
- Regular breakfast eater (at least 4 times per week)
- Stable weight within the past three months
Who cannot join
- Psychiatric disease
- Use of psychotropic medications
- History of eating disorder
- History of excessive exercise within the last three months
- History of diabetes mellitus
- Active substance abuse
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- Hematocrit below normal range
- Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
- History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)
- Untreated thyroid disease
- Tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans
Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. The effects of oxytocin administration on eating behavior in humans, which could have important implications in eating-related disorders ranging from obesity to anorexia nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of single-dose oxytocin administration investigates whether:
- Caloric intake will decrease following administration of oxytocin versus placebo
- Appetite will decrease following administration of oxytocin versus placebo
- Resting energy expenditure will increase following administration of oxytocin versus placebo
- Conditions
- Eating Behavior
- Being tested
- Oxytocin, Placebo
- Keywords
- Eating behavior, Appetite, Oxytocin, Neuropeptide
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon (Novartis)
Intranasal oxytocin 24 IU single-dose administration
PlaceboDrug
Intranasal Placebo single-dose administration
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Intranasal oxytocin Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Intranasal placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric intake
Measured: +60 minutes after drug/placebo
Secondary outcomes (2)
Appetite
Assessed using a Visual Analogue Scale
Measured: +55 (fasting) and +90 minutes (post-prandial) after drug/placebo
Resting energy expenditure
Assessed using metabolic cart
Measured: +30 minutes after drug/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
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.
- More trials run by Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Austen Lawson, Massachusetts General Hospital
- Investigators
- Elizabeth A Lawson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513499
- Sponsor's protocol ID
- MGH1004
- Status last verified
- Apr 2019
- First submitted
- 11 Jan 2012
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans
- ClinicalTrials.gov ID
- NCT01513499
- Acronym / sponsor ID
- MGH1004
- Conditions
- Eating Behavior
- Keywords
- Eating behavior, Appetite, Oxytocin, Neuropeptide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Jan 2012 (estimated)
- 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.
Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. The effects of oxytocin administration on eating behavior in humans, which could have important implications in eating-related disorders ranging from obesity to anorexia nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of single-dose oxytocin administration investigates whether:
- Caloric intake will decrease following administration of oxytocin versus placebo
- Appetite will decrease following administration of oxytocin versus placebo
- Resting energy expenditure will increase following administration of oxytocin versus placebo
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: OxytocinIntranasal oxytocin |
| Placebo | Placebo comparator | Drug: PlaceboIntranasal placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-45 years old
- BMI 18.5-24.9, 25-40
- Regular breakfast eater (at least 4 times per week)
- Stable weight within the past three months
Key exclusion criteria (11 listed)
- Psychiatric disease
- Use of psychotropic medications
- History of eating disorder
- History of excessive exercise within the last three months
- History of diabetes mellitus
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 |
|---|---|---|
| OxytocinAlso: Syntocinon (Novartis)Intranasal oxytocin 24 IU single-dose administration | Drug | Oxytocin |
| PlaceboIntranasal Placebo single-dose administration | Drug | Placebo |
Primary outcome
Caloric intake
Time frame: +60 minutes after drug/placebo
2 secondary outcomes
Appetite
Time frame: +55 (fasting) and +90 minutes (post-prandial) after drug/placebo
Resting energy expenditure
Time frame: +30 minutes after drug/placebo
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 8 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth A Lawson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin in people with Eating Behavior, run by Massachusetts General Hospital at 1 site in United States.
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 4 inclusion and 11 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 8 Apr 2019. 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 States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Caloric intake (time frame: +60 minutes after drug/placebo). 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 8 Apr 2019.