Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

NCT01784692 | Completed

• 1 other identifier: 2012-0255
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Immulina; Elderly; Immune

Outcome Measures

Primary Outcomes (1)

• Interferon gamma (IFNg)

  Increase in IFNg from baseline to 8 weeks

  8 weeks

Secondary Outcomes (4)

• Psychological Measures

  8 weeks

• Optimal supplement regime

  8 weeks

• Demographic differences

  8 weeks

• Immune biomarkers

  8 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

10 participants will be randomized to take 1 capsule of placebo daily.

Dietary Supplement: Immulina

Immulina 200 mg/day

EXPERIMENTAL

10 participants will be randomized to take 200 mg/day of Immulina.

Dietary Supplement: Immulina

Immulina 400 mg/day

EXPERIMENTAL

10 participants will be randomized to take 400 mg/day of Immulina.

Dietary Supplement: Immulina

Immulina 800 mg/day

EXPERIMENTAL

10 participants will be randomized to take 800 mg/day of Immulina.

Dietary Supplement: Immulina

Interventions

Immulina DIETARY_SUPPLEMENT

Also known as: Spirulina

Immulina 200 mg/day; Immulina 400 mg/day; Immulina 800 mg/day; Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Interventions

Immulina

Study Officials

• Gailen D. Marshall, Jr., MD, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pediatrics, Vice Chair for Research, Department of Medicine, Director, Division of Clinical Immunology and Allergy, Chief, Laboratory of Behavioral Immunology Research

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 26, 2016

Record last verified: 2016-05

Locations

US (1)