Skip to main content
OpenTrials
Completed

NCT Number: NCT01195077

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cancer Prevention and Control Program/University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of HIV
  • Able to swallow pills

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Dietary algae influence on CD4 helper cells and HIV viral load

    Time frame: Once a week for first 3 weeks, then once a month

    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.

Secondary outcomes

  1. 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.

    The combination of the 2 algae appeared to have more benefit. However, the sample size was too small to make conclusions.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Acronym: HIV

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 3, 2010
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.