TABLE 3.
Time of study visit | Fixed effect of randomization* | ||||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | 3 mo | 6 mo | 12 mo | ||||||
| |||||||||
n | n (%) | n | n (%) | n | n (%) | n | n (%) | ||
RNA detectable (yes) | |||||||||
Placebo | 27 | 11 (41) | 27 | 12 (44) | 27 | 13 (48) | 23 | 13 (57) | |
Supplement | 28 | 13 (46) | 30 | 12 (40) | 30 | 15 (50) | 27 | 15 (56) | |
| |||||||||
n | mean ± SD | n | mean ± SD | n | mean ± SD | n | mean ± SD | LSMean ± SE | |
| |||||||||
RNA detectable (log10 copies/mL) | |||||||||
Placebo | 11 | 3.06 ± 1.02 | 12 | 3.57 ± 1.23 | 13 | 3.36 ± 0.94 | 13 | 3.78 ± 1.06† | 3.53 ± 0.15 |
Supplement | 13 | 3.29 ± 0.92 | 12 | 2.99 ± 0.84 | 15 | 3.03 ± 1.00 | 15 | 3.12 ± 0.81 | 3.06 ± 0.14§ |
CD3% | |||||||||
Placebo | 28 | 79.4 ± 8.4 | 27 | 79.6 ± 10.0 | 26 | 81.1 ± 9.5 | 23 | 81.0 ± 10.1 | 81.8 ± 1.0 |
Supplement | 30 | 78.8 ± 5.8 | 30 | 80.1 ± 6.8 | 30 | 81.4 ± 6.4‡ | 27 | 82.7 ± 6.7‡ | 80.1 ± 0.9 |
CD4% | |||||||||
Placebo | 28 | 32.9 ± 14.4 | 27 | 31.2 ± 14.1† | 26 | 31.9 ± 13.7 | 23 | 33.1 ± 14.8 | 30.6 ± 1.0 |
Supplement | 30 | 30.8 ± 9.5 | 30 | 31.8 ± 9.2 | 30 | 31.9 ± 8.0 | 27 | 32.3 ± 11.1 | 33.1 ± 0.9|| |
CD8% | |||||||||
Placebo | 28 | 43.1 ± 15.1 | 27 | 45.0 ± 15.2 | 26 | 45.9 ± 14.6 | 23 | 45.0 ± 14.4 | 45.6 ± 1.2 |
Supplement | 30 | 44.8 ± 9.0 | 30 | 45.6 ± 10.3 | 30 | 46.5 ± 10.3 | 27 | 46.7 ± 10.3 | 46.2 ± 1.1 |
CD19% | |||||||||
Placebo | 28 | 10.6 ± 5.2 | 27 | 8.7 ± 4.7 | 27 | 8.9 ± 6.2 | 23 | 8.1 ± 5.4† | 8.3 ± 0.6 |
Supplement | 30 | 9.5 ± 3.5 | 30 | 8.3 ± 4.0 | 30 | 7.8 ± 3.9† | 27 | 7.1 ± 4.0† | 7.9 ± 0.6 |
Th memory% | |||||||||
Placebo | 28 | 51.1 ± 13.7 | 27 | 49.7 ± 16.2 | 26 | 50.8 ± 16.4 | 23 | 52.0 ± 19.0 | 49.2 ± 1.2 |
Supplement | 30 | 47.4 ± 11.4 | 30 | 44.6 ± 9.2† | 30 | 45.4 ± 10.9 | 27 | 46.8 ± 9.8 | 47.2 ± 1.1 |
Th naïve% | |||||||||
Placebo | 28 | 44.4 ± 12.3 | 27 | 42.6 ± 12.1 | 26 | 43.6 ± 11.4 | 23 | 42.5 ± 15.5 | 42.9 ± 1.0 |
Supplement | 30 | 45.1 ± 13.0 | 30 | 47.0 ± 10.7† | 29 | 47.8 ± 11.3 | 27 | 46.7 ± 10.0 | 47.1 ± 0.9¶ |
NK% | |||||||||
Placebo | 28 | 8.4 ± 5.8 | 27 | 10.0 ± 8.3 | 26 | 9.8 ± 7.7 | 23 | 9.3 ± 8.0 | 10.1 ± 0.8 |
Supplement | 30 | 8.8 ± 4.6 | 30 | 9.2 ± 4.9 | 30 | 8.5 ± 3.8 | 27 | 9.0 ± 5.4 | 8.5 ± 0.7 |
NKp30% | |||||||||
Placebo | 28 | 44.8 ± 23.9 | 27 | 40.6 ± 22.2 | 27 | 42.2 ± 22.7 | 23 | 43.9 ± 22.1 | 40.8 ± 2.1 |
Supplement | 30 | 41.4 ± 25.8 | 30 | 40.2 ± 20.9 | 30 | 39.5 ± 19.7 | 27 | 40.1 ± 26.5 | 41.3 ± 2.0 |
NKp44% | |||||||||
Placebo | 28 | 1.7 ± 2.0 | 27 | 0.8 ± 1.3† | 27 | 1.0 ± 0.9† | 23 | 1.6 ± 2.7 | 1.1 ± 0.2 |
Supplement | 30 | 1.6 ± 2.0 | 30 | 1.1 ± 1.2 | 30 | 1.8 ± 3.2 | 27 | 1.2 ± 1.8 | 1.4 ± 0.2§ |
NKp46% | |||||||||
Placebo | 28 | 52.8 ± 23.8 | 27 | 55.9 ± 23.3 | 27 | 48.8 ± 23.5 | 23 | 50.7 ± 25.5 | 50.4 ± 2.9 |
Supplement | 30 | 48.5 ± 25.1 | 30 | 49.2 ± 21.1 | 30 | 47.5 ± 19.6 | 27 | 47.1 ± 24.8 | 49.0 ± 2.8 |
HLA-DR% | |||||||||
Placebo | 28 | 25.4 ± 17.6 | 27 | 27.4 ± 17.9 | 26 | 25.1 ± 16.7 | 23 | 22.0 ± 15.7 | 24.9 ± 1.9 |
Supplement | 30 | 24.2 ± 14.3 | 30 | 22.5 ± 14.1 | 30 | 22.0 ± 14.2 | 27 | 23.5 ± 14.5 | 23.0 ± 1.7 |
Definitions: CD3%, T cells %, CD45+/CD3+; CD4%, T helper cells %, CD45+/CD3+/CD4+; CD8%, T cytotoxic cells %, CD45+/CD3+/CD8+; CD19%, B cells %, CD45+/CD3−/CD19+; HLA-DR%, activated cytotoxic T cells %, CD3+/CD8+/CD38+; LSMean, least square mean; NK%, NK (natural killer) cells %, CD45+/CD3−/CD16+CD56+; NKp30%, NKp30+ NK cells % (natural cytotoxicity receptor), CD45+/CD3−/CD16+CD56+/NKp30+; NKp44%, NKp44+ NK cells % (natural cytotoxicity receptor), CD45+/CD3−/CD16+CD56+/NKp44+; NKp46%, NKp46+ NK cells % (natural cytotoxicity receptor), CD45+/CD3−/CD16+CD56+/NKp46+; Th memory%, memory T helper cells %, CD3+/CD4+/CD45RA−/CD45RO+; Th naïve%, naïve T helper cells %, CD3+/CD4+/CD45RA+/CD62L+.
Results are the fixed effect of randomization group from multilevel regression model (SAS PROC MIXED) testing for persistence of response at 3–12 months based on untransformed data, also controlling for time of study visit and adjusting for baseline values; data are LSMean ± SE. The significance of the fixed effect was assessed or confirmed based on log10-transformed data.
Significantly different from baseline within randomization group by paired t-test at P < 0.05;
P < 0.01.
Fixed effect for supplementation significantly different from placebo at P < 0.05;
P < 0.01.
Fixed effect for supplementation significantly different from placebo at P < 0.10.