StressEarly Phase 1NCT00482404
Effects of Romantic Affection on Blood Chemistry and Immune Parameters
A Early Phase 1 study testing Romantic kissing in people with Stress and Hypercholesterolemia, run by Arizona State University.
Trial summary
This trial tests the hypothesis that increasing nonverbal affection in romantic relationships will improve blood lipid parameters (total cholesterol, high and low density lipoproteins, triglycerides), blood glucose, and immune parameters (C-reactive protein and antibodies to latent Epstein-Barr virus). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Hypercholesterolemia
- What is being tested?
- Romantic kissing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2007to May 2007
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+ years of age;
- English-speaking;
- Current co-habitation with romantic partner
Who cannot join
- History of hypercholesterolemia;
- Current pregnancy;
- Current use of blood-thinning agents;
- Greater than moderate anxiety about giving capillary blood;
- Weight of less than 110 pounds
About this study
Official title: Study of the Effects of Romantic Affection on Blood Lipids, Blood Glucose, C-Reactive Protein, and Antibodies to Latent Epstein-Barr Virus
This trial tests the hypothesis that increasing nonverbal affection in romantic relationships will improve blood lipid parameters (total cholesterol, high and low density lipoproteins, triglycerides), blood glucose, and immune parameters (C-reactive protein and antibodies to latent Epstein-Barr virus). 52 healthy cohabiting romantic couples took part. In half of the couples, one partner increased the frequency of romantic kissing with the other partner during the six-week trial. The other couples received no such instruction. Blood tests performed before and after the trial were used to assess the health outcomes.
- Conditions
- Stress, Hypercholesterolemia
- Being tested
- Romantic kissing
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romantic kissingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startFeb 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Kory Floyd, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482404
- Sponsor's protocol ID
- 1001 R03 MH075757-01A1
- Status last verified
- Jun 2007
- First submitted
- 4 Jun 2007
- Last updated
- 5 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Romantic Affection on Blood Lipids, Blood Glucose, C-Reactive Protein, and Antibodies to Latent Epstein-Barr Virus
- ClinicalTrials.gov ID
- NCT00482404
- Acronym / sponsor ID
- 1001 R03 MH075757-01A1
- Conditions
- Stress, Hypercholesterolemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2007
- Study completion
- May 2007 (actual)
- First posted
- 5 Jun 2007 (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.
This trial tests the hypothesis that increasing nonverbal affection in romantic relationships will improve blood lipid parameters (total cholesterol, high and low density lipoproteins, triglycerides), blood glucose, and immune parameters (C-reactive protein and antibodies to latent Epstein-Barr virus). 52 healthy cohabiting romantic couples took part. In half of the couples, one partner increased the frequency of romantic kissing with the other partner during the six-week trial. The other couples received no such instruction. Blood tests performed before and after the trial were used to assess the health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years of age;
- English-speaking;
- Current co-habitation with romantic partner
Key exclusion criteria (5 listed)
- History of hypercholesterolemia;
- Current pregnancy;
- Current use of blood-thinning agents;
- Greater than moderate anxiety about giving capillary blood;
- Weight of less than 110 pounds
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 |
|---|---|---|
| Romantic kissing | Behavioural | – |
Primary outcome
Not reported in the source record.
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 5 Jun 2007.
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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.
Kory Floyd, PhD principal investigator
Arizona State University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Romantic kissing in people with Stress and Hypercholesterolemia, run by Arizona State University.
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 3 inclusion and 5 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 5 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
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 5 Jun 2007.