Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

Not Applicable

Completed

• Conditions: Elderly Immune Senescence
• Interventions: Dietary Supplement: Immulina

• Registration Number: NCT01784692
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-06
• Study Start: 2013-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Immulina	10 participants will be randomized to take 1 capsule of placebo daily.
Immulina 800 mg/day	Immulina	10 participants will be randomized to take 800 mg/day of Immulina.
Immulina 400 mg/day	Immulina	10 participants will be randomized to take 400 mg/day of Immulina.
Immulina 200 mg/day	Immulina	10 participants will be randomized to take 200 mg/day of Immulina.

Primary Outcome Measures

Name	Time	Method
Interferon gamma (IFNg)	8 weeks	Increase in IFNg from baseline to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Psychological Measures	8 weeks	Effects of Immulina on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry
Optimal supplement regime	8 weeks	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
Demographic differences	8 weeks	Effects of Immulina based upon demographic differences including gender, race, age, BMI and socioeconomic status
Immune biomarkers	8 weeks	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

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States