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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
seaweed, spirulina, seaweed + spirulina
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Dietary intervention, Algae, HIV progression, Algae specific kind

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of HIV
  • Able to swallow pills

Exclusion Criteria:

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

Sites / Locations

  • Cancer Prevention and Control Program/University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Seaweed, Spirulina, Seaweed + Spirulina

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Would seaweed (Undaria) or spirulina or a combination of the two algae have more benefit?
The combination of the 2 algae appeared to have more benefit. However, the sample size was too small to make conclusions.

Full Information

First Posted
September 2, 2010
Last Updated
May 10, 2021
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01195077
Brief Title
Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?
Acronym
HIV
Official Title
Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Dietary intervention, Algae, HIV progression, Algae specific kind

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seaweed, Spirulina, Seaweed + Spirulina
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
seaweed, spirulina, seaweed + spirulina
Intervention Description
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 Outcome Measure Information:
Title
Dietary algae influence on CD4 helper cells and HIV viral load
Description
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.
Time Frame
Once a week for first 3 weeks, then once a month
Secondary Outcome Measure Information:
Title
Would seaweed (Undaria) or spirulina or a combination of the two algae have more benefit?
Description
The combination of the 2 algae appeared to have more benefit. However, the sample size was too small to make conclusions.
Time Frame
Participants were randomized to one of 3 treatments.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of HIV Able to swallow pills Exclusion Criteria: Allergy to iodine/seafood Thyroid disease Not taking antiretroviral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Teas, Ph.D.
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Prevention and Control Program/University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

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

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