Effects of chocolate containing strain NTM048 on immune function: a randomized, double-blind, placebo-controlled trial.

BACKGROUND

Previous reports showed that oral administration of strain NTM048 increases IgA levels and CD4+ T cell population in feces and mice, respectively, as revealed by flow cytometric analysis of splenocytes. This study aimed to evaluate the effect of chocolate supplemented with strain NTM048 (> 1.00 × 10 CFU/day, NTM048) on the immune parameters of healthy subjects, using a randomized, placebo-controlled, double-blinded study design.

METHODS

Participants (mean age: 46.3 years) ingested 28 g of test food daily, at a time of their own choice, for 4 weeks. The immunological parameters of all participants were evaluated two times (pre- and post- ingestion). At the end of the study, various immunological parameters of the participants were measured and scoring of immunological vigor (SIV) was performed using a comprehensive algorithm.

RESULTS

Ingestion of NTM048-supplemented chocolate significantly improved SIV in the NTM048 group (18.6 ± 1.6) compared to that in the placebo group (17.8 ± 2.0) after 4 weeks ( = 0.049). Several immunological parameters (CD8T cells, CD8CD28 T cells, and memory T cells) were significantly elevated in the NTM048 group as compared to the placebo group (all  < 0.05). In addition, T cell proliferation index at post-ingestion significantly increased compared with that at pre-ingestion in the NTM048 ( = 0.017) and placebo groups ( = 0.037), although no differences were observed between the two groups.

CONCLUSION

Our results suggest that ingestion of chocolate supplemented with NTM048 is effective against the age-related decline in T cell-related immune functions.

TRIAL REGISTRATION

UMIN Clinical Trials Registry UMIN000021989. Registered 19 April 2016, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025321.