Elderly Immune SenescenceNCT01784692
Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
A study testing Immulina in people with Elderly Immune Senescence, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly Immune Senescence
- What is being tested?
- Immulina
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Sep 2014
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 and older;
- Generally otherwise healthy for age and not taking medications/supplements that could be expected to affect stress responses and/or impact immune parameters (example - systemic steroids, beta blockers, antidepressants, anti-anxiety drugs, Echinacea supplements, ginseng supplements or Spirulina supplements).
Who cannot join
- Inability to comprehend and speak English;
- Any history of major psychological or psychiatric illness (example - dementia, psychotic disorder, acute mania, current substance abuse) that may limit participant cooperation or compromise the integrity of self-reported clinical or psychological data;
- Presence of a confounding underlying systemic illness which could interfere with immunological profiles (example - severe cardiovascular, pulmonary, hepatic, gastrointestinal, renal, neurological, musculoskeletal endocrine , or metabolic systems; other gross physical impairments; or any history of significant convulsive disorder). Specifically, patients with congestive heart failure, recent viral or bacterial illness in the past 3 weeks, chronic kidney disease, thyroid disorder, autoimmune disease will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.
- Conditions
- Elderly Immune Senescence
- Being tested
- Immulina
- Keywords
- Immulina, Elderly, Immune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmulinaDietary supplement
Also called Spirulina
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 10 participants will be randomized to take 1 capsule of placebo daily. Receives: Dietary Supplement: Immulina |
| Immulina 200 mg/day | Experimental | 10 participants will be randomized to take 200 mg/day of Immulina. Receives: Dietary Supplement: Immulina |
| Immulina 400 mg/day | Experimental | 10 participants will be randomized to take 400 mg/day of Immulina. Receives: Dietary Supplement: Immulina |
| Immulina 800 mg/day | Experimental | 10 participants will be randomized to take 800 mg/day of Immulina. Receives: Dietary Supplement: Immulina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interferon gamma (IFNg)
Increase in IFNg from baseline to 8 weeks
Measured: 8 weeks
Secondary outcomes (4)
Psychological Measures
Effects of Immulina on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry
Measured: 8 weeks
Optimal supplement regime
Optimizing Immulina dose for maximal immune biomarker levels observing changes in Treg, Tr1, Th3, T Helper1, T Helper 2 cells, salivary cortisol, salivary alpha amylase, Interleukin 4 and Interleukin 10 cytokine production from baseline to 8 weeks
Measured: 8 weeks
Demographic differences
Effects of Immulina based upon demographic differences including gender, race, age, BMI and socioeconomic status
Measured: 8 weeks
Immune biomarkers
Changes in Treg, Tr1, Th3, T Helper 1, T Helper 2 cells, salivary cortisol, salivary alpha amylase, Interleukin 4 and Interleukin 10 cytokine production from baseline to 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Immune SenescenceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gailen D. Marshall, University of Mississippi Medical Center
- Investigators
- Gailen D. Marshall, Jr., MD, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784692
- Sponsor's protocol ID
- 2012-0255
- Status last verified
- May 2016
- First submitted
- 4 Feb 2013
- Last updated
- 26 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
- ClinicalTrials.gov ID
- NCT01784692
- Acronym / sponsor ID
- 2012-0255
- Conditions
- Elderly Immune Senescence
- Keywords
- Immulina, Elderly, Immune
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Feb 2013 (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 will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Immulina10 participants will be randomized to take 1 capsule of placebo daily. |
| Immulina 200 mg/day | Experimental | Dietary Supplement: Immulina10 participants will be randomized to take 200 mg/day of Immulina. |
| Immulina 400 mg/day | Experimental | Dietary Supplement: Immulina10 participants will be randomized to take 400 mg/day of Immulina. |
| Immulina 800 mg/day | Experimental | Dietary Supplement: Immulina10 participants will be randomized to take 800 mg/day of Immulina. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 60 and older;
- Generally otherwise healthy for age and not taking medications/supplements that could be expected to affect stress responses and/or impact immune parameters (example - systemic steroids, beta blockers, antidepressants, anti-anxiety drugs, Echinacea supplements, ginseng supplements or Spirulina supplements).
Key exclusion criteria (3 listed)
- Inability to comprehend and speak English;
- Any history of major psychological or psychiatric illness (example - dementia, psychotic disorder, acute mania, current substance abuse) that may limit participant cooperation or compromise the integrity of self-reported clinical or psychological data;
- Presence of a confounding underlying systemic illness which could interfere with immunological profiles (example - severe cardiovascular, pulmonary, hepatic, gastrointestinal, renal, neurological, musculoskeletal endocrine , or metabolic systems; other gross physical impairments; or any history of significant convulsive disorder). Specifically, patients with congestive heart failure, recent viral or bacterial illness in the past 3 weeks, chronic kidney disease, thyroid disorder, autoimmune disease will be excluded.
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 |
|---|---|---|
| ImmulinaAlso: Spirulina | Dietary supplement | Immulina 200 mg/day, Immulina 400 mg/day, Immulina 800 mg/day, Placebo |
Primary outcome
Interferon gamma (IFNg)
Time frame: 8 weeks
Increase in IFNg from baseline to 8 weeks
4 secondary outcomes
Psychological Measures
Time frame: 8 weeks
Optimal supplement regime
Time frame: 8 weeks
Demographic differences
Time frame: 8 weeks
Immune biomarkers
Time frame: 8 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 26 May 2016.
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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.
Gailen D. Marshall, Jr., MD, PhD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immulina in people with Elderly Immune Senescence, run by University of Mississippi Medical Center 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 2 inclusion and 3 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 26 May 2016. 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.
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?
Interferon gamma (IFNg) (time frame: 8 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 26 May 2016.