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Marine-Derived Omega-3 Fatty Acids and Cardiovascular Disease
Published in Stephen T. Sinatra, Mark C. Houston, Nutritional and Integrative Strategies in Cardiovascular Medicine, 2022
Thomas G. Guilliams, Jørn Dyerberg
These differences between rTG and EE have become hotly debated, because pharmaceutical products are primarily delivered as EE, whereas dietary supplement forms are available as both EE and rTG. Therefore, in a more recent trial, researchers performed a head-to-head trial comparing the TG-lowering effects of one of the popular EE pharmaceutical products (Lovaza®) and a rTG fish oil product.84 In this randomized, double-blind, placebo-controlled trial, 120 subjects with non-fasting plasma TG levels of 150–500 mg/dL were given 3 g/day EPA and DHA as either an EE or rTG (or placebo) for 8 weeks. After supplementation, non-fasting plasma TG decreased 28% in the rTG group and 22% in the EE group (both P < 0.001 vs placebo), with no statistically significant difference between the two groups. The TG-lowering effect was seen after 4 weeks and was inversely correlated with the omega-3 index, which increased 63.2% in the rTG group and 58.5% in the EE group. In addition, heart rate decreased by three beats per minute (P = 0.045) and HDL-C increased only in the rTG group (P < 0.001). These data confirm that rTG products delivering similar amounts of total EPA and DHA as pharmaceutical EE products are at least as effective for lowering TG and may provide other cardioprotective benefits beyond the EE forms.*
Regulation of Nutraceuticals and Functional Foods
Published in Robert E.C. Wildman, Richard S. Bruno, Handbook of Nutraceuticals and Functional Foods, 2019
Rick Collins, Jay Manfre, Robert E.C. Wildman
Finally, DSHEA provides two sections about what a dietary supplement does, and does not, include.11 First, DSHEA states that a dietary supplement does include “an article that is approved as a new drug … certified as an antibiotic … or licensed as a biologic” if the article was marked as a dietary supplement or as a food prior to such approval, certification, or license.11 A perfect example of this is in the case of fish oil. Fish oil supplements have been marketed and sold in the United States for centuries, long before the passage of DSHEA. In the early 2000s, Reliant Pharmaceuticals developed a highly purified, chemically altered version of omega-3-acid ethyl esters that was put through the FDA drug approval process.12 The FDA-approved prescription fish oil Lovaza was sold by GlaxoSmithKline for the treatment of very high triglycerides.12 Because omega-3 fish oils were marketed and sold as dietary supplements prior to Lovaza's approval as a drug, they are still able to be legally marketed and sold as dietary supplements notwithstanding the new drug approval. The same is true for other products that were marketed and sold as dietary supplements prior to their approval as drugs—vitamin D is available as a dietary supplement and as a prescription drug called Drisdol.
Identification and Management of Children with Dyslipidemia
Published in James M. Rippe, Lifestyle Medicine, 2019
Julie A. Brothers, Stephen R. Daniels
Omega-3 fatty acids (or fish oil) decrease the synthesis of hepatic fatty acid and TG and increase the degradation of fatty acids, leading to decreased VLDL-C release and lower TG levels. The use of omega-3 fish oil capsules at doses of 2 to 4 g/day is safe and effective in adults and can lower TG by 30–45% and increase HDL-C levels by 6–17%, but it may increase LDL-C levels up to 31%.50 There have been mixed results in the adult literature regarding primary CVD reduction with TG lowering from omega-3 fatty acids,51,52 but those with elevated TGs and low HDL-C levels appear to be a subgroup in which CVD risk reduction may be seen.53 In children, one small randomized trial of 25 patients with hypertriglyceridemia (average TG 227 mg/dL) using four grams of prescription fish oil (Lovaza) did not show a significant difference in the treatment versus the placebo groups.54 There have been no reports of adverse effects on muscle, liver, or glucose levels.50 There are a few FDA approved fish oil capsule preparations as well as several over-the-counter omega-3 fish oil capsules sold as nutritional supplements. Dosing for TG-lowering effect should be 2000 to 4000 mg daily of the eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) components of the fish oil capsule.
N-3 Long Chain Fatty Acids Supplementation, Fatty Acids Desaturase Activity, and Colorectal Cancer Risk: A Randomized Controlled Trial
Published in Nutrition and Cancer, 2022
Harvey J. Murff, Martha J. Shrubsole, Qiuyin Cai, Timothy Su, Jennings H. Dooley, Sunny S. Cai, Wei Zheng, Qi Dai
The randomization schedule was devised by the study statistician and only the study statistician and only the Vanderbilt Investigational Drug Service (IDS) had access to the randomization tables. Randomization was performed according to a permuted block randomization scheme stratified on FADS1 rs174537 genotypes (G/G, G/T, T/T). Participants were further randomized to either three capsules of the n-3 LCPUFA supplement Lovaza® (GlaxoSmithKline, Research Triangle, NC) (total daily dose of 1,395 mg EPA plus 1,125 mg DHA) or three capsules of an olive oil supplement with each capsule contained 1,000 mg of olive oil. Both capsules were similar in size, shape and appearance. Medications were dispensed by the IDS. Participants and all study personnel were unaware of the randomization list or treatment assignment. Laboratory staff and the study pathologists were also blinded to the randomization status of the participants. To assess the study blinding, subjects were asked at the end of the study which treatment they thought they had received. Adherence was assessed by pill counts and red blood cell n-3 LCPUFA measurements.
Differentiating Full-Spectrum Hemp Extracts from CBD Isolates: Implications for Policy, Safety and Science
Published in Journal of Dietary Supplements, 2020
Osvaldo Marinotti, Miles Sarill
Hemp, CBD and associated non-psychotoxic phytocannabinoids were erroneously scheduled as controlled substances, making it impossible to market hemp-derived CBD prior to the passage of DSHEA on October 25, 1994. Under the current FDA dietary supplements framework, it is not lawful to sell CBD as a supplement because of approval of CBD as Epidiolex, an active drug ingredient under section 505 of the FD&C Act [21 U.S.C. § 355], which excludes CBD from the definition as a dietary supplement. Companies aspiring to investigate therapeutic applications for phytocannabinoids are required to go through FDA drug approval process. However, companies following Good Manufacturing Practices (GMP) and preparing full-spectrum plant botanical extracts from the legal hemp plant for use in consumer products at levels that have been scientifically demonstrated to be safe should have a lawful pathway to market. Consider the following: n-3 polyunsaturated fatty acids such as eicosapentaenoic acid (EPA) are found in food, dietary supplements and FDA approved pharmaceutical drugs such as Lovaza, which contain highly purified n-3 moieties (GlaxoSmithKline 2014). By this logic, hemp seeds available as food, hemp-derived CBD-containing supplements and CBD isolates for pharmaceutical application could apply the same framework. Currently, FDA is conflating the identity of CBD as an active drug ingredient with hemp extract dietary supplements. This is despite the fact that purified cannabinoid isolates are different in chemical composition and identity from full plant hemp extracts, as we have illustrated herein.
Customized Prevention Trials Could Resolve the Controversy of the Effects of Omega-3 Fatty Acids on Cancer
Published in Nutrition and Cancer, 2020
Karam El-Bayoumy, Andrea Manni
Inconsistent results have also been reported in studies testing the effect of n-3FA on several biomarkers of breast cancer. For example, Fabian et al., (5) showed that the oral administration of Lovaza (1.5 g DHA + 1.86 g EPA) for a duration of 6 months to women with evidence of hyperplasia ± atypia altered several biomarkers of breast cancer risk in a favorable manner including a decrease in cyclin D1 and Bcl2 which are downstream targets from NF-κB, a transcriptional factor that induces proinflammatory mediators; such a finding is consistent with preclinical results (24,25). In a more recent study by Gucalp et al. (6), the authors employed lower dose and formulation (1 g DHA daily), different duration (3 months) and different cohorts (patients with history of cancer, i.e. cancer survivors) and reported the lack of effect of DHA on multiple markers including those related to inflammation. In fact, Gucalp et al. (6), acknowledged that their results are inconsistent with those of Fabian et al., (5) which could be due to different protocols. Both studies raise concern about the adequacy of the duration of the intervention in assessing the effects of n-3FA. For instance, in the REDUCE-IT trial, the beneficial effects of EPA emerged only after 2 years. Of course, comparing trials testing the effects of n-3FA on cancer versus cardiovascular event presents major limitations. While the anti-inflammatory action of n-3FA can be beneficial in the prevention of both conditions, n-3FA can have a specific beneficial influence on cardiovascular events due to their ability to lower triglycerides, prevent serious arrhythmias, decrease platelet aggregation and lower blood pressure (26). In addition, future studies should be aimed at comparing directly, the impact of DHA vs EPA supplementation on cardiovascular endpoints. At present, however, the optimal dose and formulation of n-3FA required to exert an anti-inflammatory effect in breast tissues remains largely undefined.