Weight GainPhase 2NCT03225456
Oxytocin and Eating
A Phase 2 study testing Syntocinon in people with Weight Gain, run by Yale-NUS College at 1 site in Singapore.
Trial summary
In this protocol, the investigators propose a randomised controlled trial to explore the effects of intra-nasal oxytocin administration on appetite regulation. The investigators will run a cross-over design with 60 healthy adult men. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Syntocinon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2017to Jan 2019
- Phase
- Phase 2
- 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: Male
- Age: 21-45 years
- Normal weight: Body mass index of 18.5 to 22.9
- Have had a stable weight for the past 3 months (less than 5kg)
- Have regular breakfast meals (≥ 4 times a week of self-reported consumption of a breakfast meal)
- Have habitual sleep of 6.5-8.5 hours
- Have English as first language (or fluent in spoken and written English)
Who cannot join
- Symptoms / history of any major medical condition, including:
- Bariatric surgery or surgical obesity treatment
- Diabetes
- Cardiovascular disease
- Thyroid disease
- Anaemia
Show all 13Show fewer
- Psychiatric disorders
- Eating disorders
- Excessive exercise (running > 40 km or exercising > 10 hr in a week)
- Currently on a special diet or trying deliberately to restrict food intake
- Currently on a weight loss program
- Smoking or substance abuse
- Use of medications that can affect weight (e.g., steroids, approved weight-loss drugs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effects of Oxytocin on Appetite Regulation in Healthy Adult Men
In this protocol, the investigators propose a randomised controlled trial to explore the effects of intra-nasal oxytocin administration on appetite regulation. The investigators will run a cross-over design with 60 healthy adult men.
- Conditions
- Weight Gain
- Being tested
- Syntocinon, Placebos
- Keywords
- appetite regulation, obesity, oxytocin
- Medical subject headings
- Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntocinonDrug
Intra-nasal oxytocin
PlacebosDrug
Intra-nasal placebo
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Participants will receive two doses of 24 IU intra-nasal oxytocin (Syntocinon) in a single session Receives: Drug: Syntocinon |
| Placebo | Placebo comparator | Participants will received match placebo, again in two doses in a single session Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste sensitivity
Taste thresholds for primary taste senses, measured using psychophysical staircase procedures
Measured: 2-hour span following oxytocin administration
Taste preference
Measured using the positive/negative generalised Labeled Magnitude Scale used to
assess pleasantness
Measured: 2-hour span following oxytocin administration
Value placed upon food
Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task
Measured: 2-hour span following oxytocin administration
Secondary outcomes (1)
Subjective ratings of hunger and fullness
Measured using 100-point Visual Analogue Scales
Measured: 2-hour span following oxytocin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startSep 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, SingHealth Investigational Medicine Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225456
- Sponsor's protocol ID
- IG15-LR052
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Oxytocin on Appetite Regulation in Healthy Adult Men
- ClinicalTrials.gov ID
- NCT03225456
- Acronym / sponsor ID
- IG15-LR052
- Conditions
- Weight Gain
- Keywords
- appetite regulation, obesity, oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Collaborators
- Singapore General Hospital, SingHealth Investigational Medicine Unit
- Study start
- Sep 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 21 Jul 2017 (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.
In this protocol, the investigators propose a randomised controlled trial to explore the effects of intra-nasal oxytocin administration on appetite regulation. The investigators will run a cross-over design with 60 healthy adult men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: SyntocinonParticipants will receive two doses of 24 IU intra-nasal oxytocin (Syntocinon) in a single session |
| Placebo | Placebo comparator | Drug: PlacebosParticipants will received match placebo, again in two doses in a single session |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Gender: Male
- Age: 21-45 years
- Normal weight: Body mass index of 18.5 to 22.9
- Have had a stable weight for the past 3 months (less than 5kg)
- Have regular breakfast meals (≥ 4 times a week of self-reported consumption of a breakfast meal)
Key exclusion criteria (13 listed)
- Symptoms / history of any major medical condition, including:
- Excessive exercise (running > 40 km or exercising > 10 hr in a week)
- Currently on a special diet or trying deliberately to restrict food intake
- Currently on a weight loss program
- Smoking or substance abuse
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 |
|---|---|---|
| SyntocinonIntra-nasal oxytocin | Drug | Oxytocin |
| PlacebosIntra-nasal placebo | Drug | Placebo |
Primary outcome
Taste sensitivity
Time frame: 2-hour span following oxytocin administration
Taste thresholds for primary taste senses, measured using psychophysical staircase procedures
Taste preference
Time frame: 2-hour span following oxytocin administration
Measured using the positive/negative generalised Labeled Magnitude Scale used to assess pleasantness
Value placed upon food
Time frame: 2-hour span following oxytocin administration
Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task
1 secondary outcome
Subjective ratings of hunger and fullness
Time frame: 2-hour span following oxytocin administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Syntocinon in people with Weight Gain, run by Yale-NUS College at 1 site in Singapore.
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 13 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. 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 Singapore. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Taste sensitivity (time frame: 2-hour span following oxytocin administration). The study lists 3 primary outcomes in all. 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 21 Jul 2017.