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

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Other: seaweed, spirulina, seaweed + spirulina

• Registration Number: NCT01195077
• Lead Sponsor: University of South Carolina

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.

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 Timeline

• Study Start: 2003-02
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Clinical diagnosis of HIV
• Able to swallow pills

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seaweed, Spirulina, Seaweed + Spirulina	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.

Primary Outcome Measures

Name	Time	Method
Dietary algae influence on CD4 helper cells and HIV viral load	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 Outcome Measures

Name	Time	Method
Would seaweed (Undaria) or spirulina or a combination of the two algae have more benefit?	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.

Trial Locations

Locations (1)

Cancer Prevention and Control Program/University of South Carolina; 🇺🇸 Columbia, South Carolina, United States