Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Drawing inferences from epidemiologic studies of HIV/AIDS as well well as cell culture and animal studies of HIV inhibition by algae, we propose algal consumption as one unifying characteristic of countries with anomalously low rates. HIV/AIDS incidence and prevalence in Eastern Asia (<1/10,000 adults in Japan and Korea), compared to Africa (≈1/10 adults) strongly suggest that differences in IV drug use and sexual behavior are insufficient to explain the 1000-fold variation. Even in Africa, AIDS/HIV rates vary. Spirulina is part of the daily diet for many people living in Chad, where prevalence of HIV has remained at less than 4% for more than 20 years. Average daily algae consumption in Asia and Africa ranges between 1 to 2 tablespoons (3 - 13 grams).
HIV viral load is the main indicator of infection, however CD4 helper cell counts are most predictive of morbidity and mortality.We hypothesized that the consumption of algae could be important in diminishing the risk of HIV infection, and subsequent progression, possibly by enhancing the immune response.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Other: seaweed |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Could Dietary Algae Affect Immunity and Viral Counts in People With HIV? |
- Dietary algae influence on CD4 helper cells and HIV viral load [ Time Frame: Once a week for first 3 weeks, then once a month ] [ Designated as safety issue: Yes ]The first 6 subjects participated for 3 weeks. After analysis of the results, it was determined that there were no side effects and some indication of benefit. The next 6 subjects participated for up to 14 months.
- Would seaweed (Undaria) or spirulina or a combination of the two algae have more benefit? [ Time Frame: Participants were randomized to one of 3 treatments. ] [ Designated as safety issue: No ]The combination of the 2 algae appeared to have more benefit. However, the sample size was too small to make conclusions.
| Enrollment: | 12 |
| Study Start Date: | February 2003 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Seaweed, Spirulina, Both
Randomized to treatment
|
Other: seaweed
5 grams per day Undaria, spirulina, or both. Twice a day. Until left study
|
Detailed Description:
Twelve HIV+ patients not on antiretroviral therapy were clinically evaluated and enrolled in the three-week study. Subjects received 10 algae capsules/d. Laboratory tests of CD4 counts and HIV RNA were performed at baseline, week 1, week 2, and week 3, and then once a month. Six subjects continued for between 4 and 14 months. In addition to CD4 lymphocyte counts and viral loads, subjects were evaluated monthly for Complete Blood Counts (CBC), Liver profile, Basic Metabolic Panel, and some subjects were evaluated for thyroid function and cholesterol. All subjects completed standard HIV Quality of Life questionnaires at each clinic visit.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of HIV
- Able to swallow pills
Exclusion Criteria:
- Allergy to iodine/seafood
- Thyroid disease
- Not taking antiretroviral therapy
Contacts and Locations More Information
Publications:
| Responsible Party: | Jane Teas, University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01195077 History of Changes |
| Other Study ID Numbers: | Dietary Algae and HIV |
| Study First Received: | September 2, 2010 |
| Last Updated: | September 2, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Carolina:
|
HIV Dietary intervention Algae HIV progression Algae specific kind |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013