Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?

NCT01195077 | Completed Phase 1

• 1 other identifier: Dietary Algae and HIV
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

HIV; Dietary intervention; Algae; HIV progression; Algae specific kind

Outcome Measures

Primary Outcomes (1)

• Dietary algae influence on CD4 helper cells and HIV viral load

  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.

  Once a week for first 3 weeks, then once a month

Secondary Outcomes (1)

• Would seaweed (Undaria) or spirulina or a combination of the two algae have more benefit?

  Participants were randomized to one of 3 treatments.

Study Arms (1)

Seaweed, Spirulina, Seaweed + Spirulina

EXPERIMENTAL

Randomized to: Arm 1: Seaweed. Ten capsules of .5 grams per capsule for a total of 10 grams per day. Arm 2: Spirulina: Ten capsules of .5 grams per capsule for a total of 10 grams per day. Arm 3: Seaweed: (2.5 grams) plus Spirulina (2.5 grams). Ten capsules of .5 grams per capsule for a total of 10 grams per day.

Other: seaweed, spirulina, seaweed + spirulina

Interventions

seaweed, spirulina, seaweed + spirulina OTHER

Arm 1: Seaweed. Ten capsules of .5 grams per capsule for a total of 10 grams per day. Arm 2: Spirulina: Ten capsules of .5 grams per capsule for a total of 10 grams per day. Arm 3: Seaweed: (2.5 grams) plus Spirulina (2.5 grams). Ten capsules of .5 grams per capsule for a total of 10 grams per day. Spirulina: Ten capsules of .5 grams per capsule for a total of 10 grams per day.

Seaweed, Spirulina, Seaweed + Spirulina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of HIV
• Able to swallow pills

You may not qualify if:

• Allergy to iodine/seafood
• Thyroid disease
• Not taking antiretroviral therapy

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

Cancer Prevention and Control Program/University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (17)

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  PMID: 19107862 RESULT

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  PMID: 15379705 RESULT

• Pereira HS, Leao-Ferreira LR, Moussatche N, Teixeira VL, Cavalcanti DN, Costa LJ, Diaz R, Frugulhetti IC. Antiviral activity of diterpenes isolated from the Brazilian marine alga Dictyota menstrualis against human immunodeficiency virus type 1 (HIV-1). Antiviral Res. 2004 Oct;64(1):69-76. doi: 10.1016/j.antiviral.2004.06.006.

  PMID: 15451181 RESULT

• Cumashi A, Ushakova NA, Preobrazhenskaya ME, D'Incecco A, Piccoli A, Totani L, Tinari N, Morozevich GE, Berman AE, Bilan MI, Usov AI, Ustyuzhanina NE, Grachev AA, Sanderson CJ, Kelly M, Rabinovich GA, Iacobelli S, Nifantiev NE; Consorzio Interuniversitario Nazionale per la Bio-Oncologia, Italy. A comparative study of the anti-inflammatory, anticoagulant, antiangiogenic, and antiadhesive activities of nine different fucoidans from brown seaweeds. Glycobiology. 2007 May;17(5):541-52. doi: 10.1093/glycob/cwm014. Epub 2007 Feb 12.

  PMID: 17296677 RESULT

• Rechter S, Konig T, Auerochs S, Thulke S, Walter H, Dornenburg H, Walter C, Marschall M. Antiviral activity of Arthrospira-derived spirulan-like substances. Antiviral Res. 2006 Dec;72(3):197-206. doi: 10.1016/j.antiviral.2006.06.004. Epub 2006 Jun 30.

  PMID: 16884788 RESULT

• Buffa V, Stieh D, Mamhood N, Hu Q, Fletcher P, Shattock RJ. Cyanovirin-N potently inhibits human immunodeficiency virus type 1 infection in cellular and cervical explant models. J Gen Virol. 2009 Jan;90(Pt 1):234-43. doi: 10.1099/vir.0.004358-0.

  PMID: 19088294 RESULT

• Wang H, Ooi EV, Ang PO Jr. Antiviral activities of extracts from Hong Kong seaweeds. J Zhejiang Univ Sci B. 2008 Dec;9(12):969-76. doi: 10.1631/jzus.B0820154.

  PMID: 19067465 RESULT

• Artan M, Li Y, Karadeniz F, Lee SH, Kim MM, Kim SK. Anti-HIV-1 activity of phloroglucinol derivative, 6,6'-bieckol, from Ecklonia cava. Bioorg Med Chem. 2008 Sep 1;16(17):7921-6. doi: 10.1016/j.bmc.2008.07.078. Epub 2008 Jul 29.

  PMID: 18693022 RESULT

• Queiroz KC, Medeiros VP, Queiroz LS, Abreu LR, Rocha HA, Ferreira CV, Juca MB, Aoyama H, Leite EL. Inhibition of reverse transcriptase activity of HIV by polysaccharides of brown algae. Biomed Pharmacother. 2008 Jun;62(5):303-7. doi: 10.1016/j.biopha.2008.03.006. Epub 2008 Apr 4.

  PMID: 18455359 RESULT

• Gideon TP, Rengasamy R. Toxicological evaluation of fucoidan from Cladosiphon okamuranus. J Med Food. 2008 Dec;11(4):638-42. doi: 10.1089/jmf.2007.0127.

  PMID: 19053854 RESULT

• Paskaleva EE, Lin X, Duus K, McSharry JJ, Veille JC, Thornber C, Liu Y, Lee DY, Canki M. Sargassum fusiforme fraction is a potent and specific inhibitor of HIV-1 fusion and reverse transcriptase. Virol J. 2008 Jan 15;5:8. doi: 10.1186/1743-422X-5-8.

  PMID: 18197976 RESULT

• Paskaleva EE, Lin X, Li W, Cotter R, Klein MT, Roberge E, Yu EK, Clark B, Veille JC, Liu Y, Lee DY, Canki M. Inhibition of highly productive HIV-1 infection in T cells, primary human macrophages, microglia, and astrocytes by Sargassum fusiforme. AIDS Res Ther. 2006 May 25;3:15. doi: 10.1186/1742-6405-3-15.

  PMID: 16725040 RESULT

• Ahn MJ, Yoon KD, Kim CY, Kim JH, Shin CG, Kim J. Inhibitory activity on HIV-1 reverse transcriptase and integrase of a carmalol derivative from a brown Alga, Ishige okamurae. Phytother Res. 2006 Aug;20(8):711-3. doi: 10.1002/ptr.1939.

  PMID: 16775811 RESULT

• Ahn MJ, Yoon KD, Min SY, Lee JS, Kim JH, Kim TG, Kim SH, Kim NG, Huh H, Kim J. Inhibition of HIV-1 reverse transcriptase and protease by phlorotannins from the brown alga Ecklonia cava. Biol Pharm Bull. 2004 Apr;27(4):544-7. doi: 10.1248/bpb.27.544.

  PMID: 15056863 RESULT

• Simpore J, Zongo F, Kabore F, Dansou D, Bere A, Nikiema JB, Pignatelli S, Biondi DM, Ruberto G, Musumeci S. Nutrition rehabilitation of HIV-infected and HIV-negative undernourished children utilizing spirulina. Ann Nutr Metab. 2005 Nov-Dec;49(6):373-80. doi: 10.1159/000088889. Epub 2005 Oct 11.

  PMID: 16219988 RESULT

• Simpore J, Kabore F, Zongo F, Dansou D, Bere A, Pignatelli S, Biondi DM, Ruberto G, Musumeci S. Nutrition rehabilitation of undernourished children utilizing Spiruline and Misola. Nutr J. 2006 Jan 23;5:3. doi: 10.1186/1475-2891-5-3.

  PMID: 16430775 RESULT

• Yamani E, Kaba-Mebri J, Mouala C, Gresenguet G, Rey JL. [Use of spirulina supplement for nutritional management of HIV-infected patients: study in Bangui, Central African Republic]. Med Trop (Mars). 2009 Feb;69(1):66-70. French.

  PMID: 19499738 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jane Teas, Ph.D.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: February 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (1)