Omega-7 Mixed Fatty Acid Supplementation Fails to Reduce Serum Inflammatory Biomarkers: A Placebo-Controlled, Double-Blind Randomized Crossover Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Administrative Considerations
2.2. Double Blinding and Randomization
2.3. Verum and Placebo
2.4. Biomolecule Measurements (Plasma Total Fatty Acid/Cytokines/hsCRP)
2.5. Statistical Calculations
2.6. Crossover Trial Design, Procedures, and Sequence of Events
3. Results
3.1. Analysis of Compliance and Adverse Events
3.2. Two Independent Group Analysis
3.3. One Crossover Group Analysis
3.4. Fatty Acid Analysis
4. Discussion
- Three weeks of a 688 mg/day palmitoleate mixed fatty acids dietary supplement in a small, randomized, single crossover trial did not produce a statistically detectable change compared to an MCT placebo dietary supplement.
- When each time point was examined, improved subjective PROMIS® measures of fatigue and pain interference were observed between the baseline and first follow-up assessment for the placebo only by Fisher’s LSD adjustment (p < 0.03, pre-post paired F(2,75) = 2.51, two-tailed).
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Title 1 | Group A (n = 26) | Group B (n = 26) | Multiple t-Test |
---|---|---|---|
Age | 55.5 ± 13.2 | 56.3 ± 14.4 | 0.84 |
Female | 20 (6 males) | 21 (3 males) | n/a |
BMI (kg/m2) | 30.4 ± 7.6 | 28.2 ± 7.0 | 0.29 |
Cannabis use | 5 | 4 | n/a |
Type of diet reported | Ketogenic/Low carb (4) | Ketogenic/Low carb (5) | n/a |
Vegetable-based (2) | Vegetable-based (5) | ||
Gluten free (3) | Gluten free (1) | ||
Low fat (1) | Low fat (2) | ||
Other healthy (5) | Other healthy (3) | ||
Std American (11) | Std American (8) | ||
Exercise Frequencies | |||
Never | 2 | 2 | n/a |
1–2 × per month | 1 | 2 | n/a |
Once a week | 4 | 5 | n/a |
2–3 × per week | 7 | 5 | n/a |
4–5 × per week | 10 | 7 | n/a |
>5 × per week | 2 | 3 | n/a |
Biological Measurements (mean ± standard deviation) | |||
hsCRP (mg/L) | 3.7 ± 3.8 | 2.2 ± 1.9 | 0.10 |
Total Cholesterol | 222.0 ± 37.9 | 208.3 ± 45.2 | 0.25 |
HDL (mg/dL) | 54.7 ± 15.0 | 65.5 ± 20.4 | 0.04 * |
LDL (mg/dL) | 130.3 ± 35.3 | 115.1 ± 43.5 | 0.18 |
VLDL (mg/dL) | 37.0 ± 17.2 | 27.8 ± 16.2 | 0.06 |
TG(mg/dL) | 184.8 ± 87.7 | 139.3 ± 81.5 | 0.01 * |
TNF (pg/mL) | 16.3 ± 11.0 | 17.8 ± 15.2 | 0.68 |
IL-6 (pg/mL) | 1.3 ± 1.7 | 0.9 ± 1.0 | 0.30 |
M ± SD | N | Difference ± SEM | Df | Holm-Sidak Method Adjusted p-Value | |
---|---|---|---|---|---|
hsCRP_p | −0.07 ± 1.70 | 49 | |||
hsCRP_v | 0.27 ± 1.51 | 50 | −0.31 ± 0.32 | 97 | 0.80 |
TNFα_p | −0.30 ± 4.85 | 49 | |||
TNFα_v | 0.94 ± 3.16 | 50 | −1.24 ± 0.82 | 97 | 0.58 |
IL6_p | −0.21 ± 1.50 | 49 | |||
IL6_v | 0.04 ± 1.45 | 50 | −0.25 ± 0.30 | 97 | 0.80 |
Fatigue_p | −0.23 ± 0.62 | 49 | |||
Fatigue_v | −0.11 ± 0.68 | 50 | −0.13 ± 0.13 | 97 | 0.80 |
PainInt_p | −0.35 ± 0.59 | 49 | |||
PainInt_v | −0.18 ± 0.82 | 50 | −0.17 ± 0.14 | 97 | 0.76 |
PhyFunc_p | −0.11 ± 0.49 | 49 | |||
PhyFunc_v | −0.17 ± 0.73 | 50 | 0.06 ± 0.12 | 97 | 0.80 |
Placebo Capsule (mg/g) | Verum Capsule (mg/g) | Baseline Plasma (µg/mL) | Placebo Plasma (µg/mL) | Verum Plasma (µg/mL) | |
---|---|---|---|---|---|
C8:0 | 526.58 ± 0.12 | 9.74 ± 1.13 | 0.04 ± 0.10 | 0.09 ± 0.24 | 0.00 ± 0.00 |
C10:0 | 359.20 ± 0.76 | 6.15 ± 0.78 | 1.05 ± 0.73 | 1.19 ± 1.28 | 1.02 ± 0.92 |
C12:0 | 0.44 ± 0.00 | 0.04 ± 0.01 | 0.86 ± 1.89 | 0.61 ± 1.25 | 0.12 ± 0.08 |
C16:0 | 0.23 ± 0.03 | 261.65 ± 0.91 | 1065.96 ± 282.45 | 995.13 ± 210.52 | 939.40 ± 308.84 |
C16:1n7 | 2.14 ± 0.10 | 452.16 ± 1.72 | 84.68 ± 41.96 | 71.40 ± 37.19 | 78.29 ± 46.55 |
C20:5n3 | 0.10 ± 0.07 | 1.71 ± 0.23 | 29.81 ± 14.82 | 31.52 ± 18.79 | 27.04 ± 10.08 |
C22:6n3 | 0.21 ± 0.07 | 4.92 ± 0.17 | 71.73 ± 53.74 | 78.09 ± 46.40 | 61.11 ± 23.85 |
Total | 891.28 ± 0.01 | 761.92 ± 2.34 | n/a | n/a | n/a |
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Sasagawa, M.; Boclair, M.J.; Amieux, P.S. Omega-7 Mixed Fatty Acid Supplementation Fails to Reduce Serum Inflammatory Biomarkers: A Placebo-Controlled, Double-Blind Randomized Crossover Trial. Nutrients 2021, 13, 2801. https://doi.org/10.3390/nu13082801
Sasagawa M, Boclair MJ, Amieux PS. Omega-7 Mixed Fatty Acid Supplementation Fails to Reduce Serum Inflammatory Biomarkers: A Placebo-Controlled, Double-Blind Randomized Crossover Trial. Nutrients. 2021; 13(8):2801. https://doi.org/10.3390/nu13082801
Chicago/Turabian StyleSasagawa, Masa, Miranda J. Boclair, and Paul S. Amieux. 2021. "Omega-7 Mixed Fatty Acid Supplementation Fails to Reduce Serum Inflammatory Biomarkers: A Placebo-Controlled, Double-Blind Randomized Crossover Trial" Nutrients 13, no. 8: 2801. https://doi.org/10.3390/nu13082801