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

May 10, 2021 updated by: University of South Carolina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • Cancer Prevention and Control Program/University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of HIV
  • Able to swallow pills

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once a week for first 3 weeks, then once a month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants were randomized to one of 3 treatments.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Investigators

  • Principal Investigator: Jane Teas, Ph.D., University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (Estimate)

September 3, 2010

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dietary Algae and HIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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