Omega-7 Mixed Fatty Acid Supplementation Fails to Reduce Serum Inflammatory Biomarkers: A Placebo-Controlled, Double-Blind Randomized Crossover Trial

Nutrients. 2021 Aug 16;13(8):2801. doi: 10.3390/nu13082801.

Abstract

We report the effects of mixed omega-7 fatty acid supplementation on changes in serum hsCRP, TNFα, and IL-6 levels and self-reported outcomes in people with non-specific chronic musculoskeletal discomfort.

Design: A double-blind, placebo-controlled, 1:1 randomized single crossover trial composed of 688 mg/day palmiteolate for the verum and an equivalent amount of medium-chain triglycerides for the placebo.

Method: Data were analyzed in two independent groups and as a crossover group.

Results: From 211 screened participants in 2017-2019, 56 were randomized. Six participants dropped out and fifty completers contributed to the statistical analyses. At baseline, none of the investigated biomarkers were significantly correlated to subjectively assessed musculoskeletal discomfort levels. For the two-group analysis (n = 26 and n = 24), none of the serum biomarkers reached statistical significance; however, a statistically significant placebo effect was found in the subjective outcomes.

Conclusion: For the crossover analysis (n = 50), three weeks of supplementation with n7FA containing 688 mg per day of palmiteolate did not reduce serum inflammatory biomarkers nor did it improve subjectively measured quality of life (QoL) compared to placebo. Future studies should explore appropriate biomarkers, sufficient power, length of dosing, inclusion criteria for volunteers with higher BMI, and the verification of cis-palmiteolate versus trans-palmiteolate.

Keywords: RCT; biomarkers; dietary supplement; omega-7 fatty acid; palmitoleic acid; placebo effect.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Biomarkers / blood
  • C-Reactive Protein / analysis
  • Cross-Over Studies
  • Dietary Supplements*
  • Double-Blind Method
  • Fatty Acids, Unsaturated / pharmacology*
  • Female
  • Humans
  • Inflammation* / blood
  • Inflammation* / metabolism
  • Interleukin-6 / blood
  • Male
  • Middle Aged
  • Placebos
  • Tumor Necrosis Factor-alpha / blood

Substances

  • Biomarkers
  • Fatty Acids, Unsaturated
  • IL6 protein, human
  • Interleukin-6
  • Placebos
  • Tumor Necrosis Factor-alpha
  • C-Reactive Protein