Randomized double blind clinical trial on the effect of oral α-cyclodextrin on serum lipids

Abstract

BackgroundThis single center, double-blinded, cross-over, placebo controlled clinical trial investigated the effect of oral α-cyclodextrin (α-CD), a soluble dietary fiber, on blood lipid and lipoprotein levels in healthy human subjects. α-CD, a cyclical polymer containing 6 glucose subunits, is currently sold as an over the counter food supplement and is also a common additive in many foods. α-CD forms a hydrophobic central cavity that binds lipids and has been shown in animal studies and in previous clinical trials to alter plasma lipid levels.MethodsWe screened for healthy subjects, males and females, between ages 18 to 75. Out of total 103 subjects interviewed, 75 subjects completed the study. Qualified individuals in each gender group were randomized into two groups in terms of which treatment arm they received first (placebo vs. α-CD, receiving 6 grams P.O. a day, for 12–14 weeks with a 7 day wash out between arms). The primary outcome variable, plasma total cholesterol, as well as other tests related to lipids and lipoprotein and glucose metabolism, were measured at baseline and at the end of each arm of the study.Resultsα-CD was well tolerated; no serious adverse events related to α-CD were observed. Approximately 8 % of the subjects on α-CD complained of minor gastrointestinal symptoms versus 3 % on placebo (p = 0.2). Small-LDL particle number decreased 10 % (p < 0.045) for subjects on α-CD versus placebo. Fasting plasma glucose (1.6 %, p < 0.05) and Insulin resistance index (11 %, p < 0.04) were also decreased when on α-CD versus placebo.Conclusionα-CD treatment appears to be safe and well tolerated in healthy individuals and showed a modest reduction in small LDL particles, and an improvement in glucose related parameters.Trial registrationNCT01131299

Dietary α‐cyclodextrin modifies gut microbiota and reduces fat accumulation in high‐fat‐diet‐fed obese mice

“…The differences between our results and the report by Artiss et al may be owing to the differences in species, diet components or ingredients, and the dose of α‐CD. Although the mechanism of the decrease in blood glucose level caused by α‐CD intake is unclear, our result showing that α‐CD intake lowered the blood glucose level corresponded to a previous clinical study reported by Amar et al, showing that 6 g of α‐CD a day for 12–14 weeks decreased fasting plasma glucose (1.6%, P < 0.05) and the insulin resistance index (11%, P < 0.05) compared with the placebo .…”

Dietary α‐cyclodextrin reduces atherosclerosis and modifies gut flora in apolipoprotein E‐deficient mice

“…Because α‐CD is granted GRAS status and thus is generally recognized as safe, it is a widely used food additive. There has been a limited number of animal and human studies indicating that α‐CD may even have beneficial effects on plasma lipids, but there has not been a previous study on its effect on atherosclerosis. We show here in apoE‐knockout mice that supplementation of a Western diet with α‐CD markedly reduces atherosclerosis (Fig.…”

“…Although plasma lipids are a major determinant of atherosclerosis both in mice and humans, many other factors can impact on the development of atherosclerosis. In humans, it is well known that serum lipids only account for about half of the variation in the propensity of atherosclerosis . In mouse models of atherosclerosis, other types of treatment, such as inulin , blueberries , long‐chain monounsaturated fatty acid‐rich fish oil , and the angiotensin II type 1 receptor blocker telmisartan all demonstrated decreased atherosclerotic lesions despite the absence of major effect on plasma lipids.…”

“…While β‐CD and inulin have been extensively studied in various human and animal studies, the effects of α‐CD are not as well understood, even though it is more widely used as a food supplement . Several small clinical trials indicate a possible beneficial role of α‐CD on plasma lipids and glucose , but whether α‐CD has a beneficial effect on suppressing the development of atherosclerosis has not yet been investigated. This is particularly important in terms of public health, as α‐CD is included in many processed foods mostly to improve texture and shelf life .…”

Effects of alpha‐cyclodextrin on cholesterol control and Compound K on glycaemic control in people with pre‐diabetes: Protocol for a Phase III randomized controlled trial

“…A later crossover trial in overweight but otherwise healthy participants found that, after supplementation with FBCx, total cholesterol, low‐density lipoprotein cholesterol and body weight were lower compared to the placebo phase . However, a second crossover trial conducted in healthy participants of any weight identified no changes in the common lipid parameters after supplementation with FBCx . In all these previous studies, participants were asked to maintain their usual dietary and exercise routine, which is likely to have reduced any potential effects of these compounds on body weight.…”