Nutrient DeficiencyNCT04650308
Sex Differences in Neuropeptide Y Serum, But Not in Fat Intake and Body Mass Index
A study testing Neuropeptide Y examination in people with Nutrient Deficiency, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
One's appetite has a role in controlling food intake and maintaining energy balance, but its effect on body metabolism related to obesity is still questionable. The purpose of this study was to determine the levels of neuropeptide Y in healthy people and to see differences in gender and anthropometric parameters. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrient Deficiency
- What is being tested?
- Neuropeptide Y examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Apr 2020to 10 Sep 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy groups for Neuropeptide Y Serum diagnosis
Who cannot join
- Non-healthy groups for Neuropeptide Y Serum diagnosis
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatra, 20155
About this study
One's appetite has a role in controlling food intake and maintaining energy balance, but its effect on body metabolism related to obesity is still questionable. The purpose of this study was to determine the levels of neuropeptide Y in healthy people and to see differences in gender and anthropometric parameters. The hypothesis of this study was that there would be differences in neuropeptide Y levels in groups with gender and anthropometric parameter differences.
Read the detailed description
One's appetite has a role in controlling food intake and maintaining energy balance, but its effect on body metabolism related to obesity is still questionable. The purpose of this study was to determine the levels of neuropeptide Y in healthy people and to see differences in gender and anthropometric parameters. The hypothesis of this study was that there would be differences in neuropeptide Y levels in groups with gender and anthropometric parameter differences. This study was a cross-sectional study involving 62 study subjects, male and female, who did not have chronic diseases or metabolic disorders. This research was conducted from April to September 2020. The parameters examined in this study were neuropeptide Y levels and anthropometric parameters. The statistical analysis performed was the Mann-Whitney test to see the differences between groups. The mean age of the research subjects was 40.48 ± 10.85 years, with the same ethnic distribution. The distribution of men and women was more women than men. Based on anthropometric examination, it was found that obesity nutritional status was more common in the female group than in the male group; however, serum neuropeptide Y levels were found to be significantly different between male and female groups (male group was higher).
- Conditions
- Nutrient Deficiency
- Being tested
- Neuropeptide Y examination
- Keywords
- obesity, appetite, neuropeptide, orexigenic, energy, gender
- Medical subject headings
- Obesity, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropeptide Y examinationDiagnostic test
This examination was conducted by drawing blood serum from research subjects and performing centrifugation with 2000-3000 revolutions per minute (RPM) for 20 minutes. Furthermore, we carried out blood serum tests to check neuropeptide Y levels using the Human Neuropeptide Y Enzyme-link Immunosorbent Assay (ELISA) kit
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Active comparator | healthy men and women aged 20-60 years old. Receives: Diagnostic Test: Neuropeptide Y examination |
| Non-healthy group | Active comparator | pregnant women, nursing mothers, impaired kidney and liver function, chronic disease, or other metabolic disorders. Receives: Diagnostic Test: Neuropeptide Y examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of neuropeptide Y
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start2 Apr 2020
- Primary completion17 Jun 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient DeficiencyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DINA KEUMALA SARI, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650308
- Sponsor's protocol ID
- USumateraUtara 2
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Neuropeptide Y Serum, But Not in Fat Intake and Body Mass Index
- ClinicalTrials.gov ID
- NCT04650308
- Acronym / sponsor ID
- USumateraUtara 2
- Conditions
- Nutrient Deficiency
- Keywords
- obesity, appetite, neuropeptide, orexigenic, energy, gender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 2 Dec 2020 (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.
One's appetite has a role in controlling food intake and maintaining energy balance, but its effect on body metabolism related to obesity is still questionable. The purpose of this study was to determine the levels of neuropeptide Y in healthy people and to see differences in gender and anthropometric parameters. The hypothesis of this study was that there would be differences in neuropeptide Y levels in groups with gender and anthropometric parameter differences.
Detailed description
One's appetite has a role in controlling food intake and maintaining energy balance, but its effect on body metabolism related to obesity is still questionable. The purpose of this study was to determine the levels of neuropeptide Y in healthy people and to see differences in gender and anthropometric parameters. The hypothesis of this study was that there would be differences in neuropeptide Y levels in groups with gender and anthropometric parameter differences. This study was a cross-sectional study involving 62 study subjects, male and female, who did not have chronic diseases or metabolic disorders. This research was conducted from April to September 2020. The parameters examined in this study were neuropeptide Y levels and anthropometric parameters. The statistical analysis performed was the Mann-Whitney test to see the differences between groups. The mean age of the research subjects was 40.48 ± 10.85 years, with the same ethnic distribution. The distribution of men and women was more women than men. Based on anthropometric examination, it was found that obesity nutritional status was more common in the female group than in the male group; however, serum neuropeptide Y levels were found to be significantly different between male and female groups (male group was higher).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | Active comparator | Diagnostic Test: Neuropeptide Y examinationhealthy men and women aged 20-60 years old. |
| Non-healthy group | Active comparator | Diagnostic Test: Neuropeptide Y examinationpregnant women, nursing mothers, impaired kidney and liver function, chronic disease, or other metabolic disorders. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy groups for Neuropeptide Y Serum diagnosis
Key exclusion criteria (1 listed)
- Non-healthy groups for Neuropeptide Y Serum diagnosis
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 |
|---|---|---|
| Neuropeptide Y examinationThis examination was conducted by drawing blood serum from research subjects and performing centrifugation with 2000-3000 revolutions per minute (RPM) for 20 minutes. Furthermore, we carried out blood serum tests to check neuropeptide Y levels using the Human Neuropeptide Y Enzyme-link Immunosorbent Assay (ELISA) kit | Diagnostic test | Healthy group, Non-healthy group |
Primary outcome
levels of neuropeptide Y
Time frame: up to 2 weeks
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 2 Dec 2020.
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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 study testing Neuropeptide Y examination in people with Nutrient Deficiency, run by Universitas Sumatera Utara at 1 site in Indonesia.
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 1 inclusion and 1 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 2 Dec 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 Indonesia. 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. 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 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?
levels of neuropeptide Y (time frame: up to 2 weeks). 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 2 Dec 2020.