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

NCT ID: NCT01195077

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Seaweed, Spirulina, Seaweed + Spirulina

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.

Group Type EXPERIMENTAL

seaweed, spirulina, seaweed + spirulina

Intervention Type 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.

Interventions

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seaweed, spirulina, seaweed + spirulina

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of HIV
* Able to swallow pills

Exclusion Criteria

* Allergy to iodine/seafood
* Thyroid disease
* Not taking antiretroviral therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Teas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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Cancer Prevention and Control Program/University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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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.

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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.

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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.

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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.

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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.

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Reference Type RESULT
PMID: 19067465 (View on PubMed)

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.

Reference Type RESULT
PMID: 18693022 (View on PubMed)

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.

Reference Type RESULT
PMID: 18455359 (View on PubMed)

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.

Reference Type RESULT
PMID: 19053854 (View on PubMed)

Trinchero J, Ponce NM, Cordoba OL, Flores ML, Pampuro S, Stortz CA, Salomon H, Turk G. Antiretroviral activity of fucoidans extracted from the brown seaweed Adenocystis utricularis. Phytother Res. 2009 May;23(5):707-12. doi: 10.1002/ptr.2723.

Reference Type RESULT
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Reference Type RESULT
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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.

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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.

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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.

Reference Type RESULT
PMID: 19499738 (View on PubMed)

Other Identifiers

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Dietary Algae and HIV

Identifier Type: -

Identifier Source: org_study_id

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