Evidence map›Paper›PMID 27405337›Full record

Trial reportLipids in health and disease2016

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

Marcelo J A Amar, Maryann Kaler, Amber B Courville, Robert Shamburek, Maureen Sampson, Alan T Remaley

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lipids in health and disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01131299 (Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01131299 phase2completednot on this map

Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2010 to 2015Enrolled103ConditionsCardiovascular DiseaseArmsPlacebo, Alpha cyclodextrin
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Science advances · 2023
    Trial
  3. Trial
  4. Review
  5. Review
  6. Cyclodextrin-based therapeutics delivery systems: A review of current clinical trials.Current research in pharmacology and drug discovery · 2025
    Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Cyclic Oligosaccharides as Active Drugs, an Updated Review.Pharmaceuticals (Basel, Switzerland) · 2020
    Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Marcelo J A AmarLipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA. ma90x@nih.gov.
Maryann KalerLipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
Amber B CourvilleLipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
Robert ShamburekLipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
Maureen SampsonLipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
Alan T RemaleyLipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
National Institutes of Health · USNational Heart Lung and Blood Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Administration, OralAdolescentAdultAgedalpha-CyclodextrinsBlood GlucoseCholesterol, HDLCholesterol, LDLDietary FiberDouble-Blind MethodFastingFemaleHealthy VolunteersHumansInsulinInsulin Resistancealpha-cyclodextrinalpha-CyclodextrinsBlood GlucoseCholesterol, HDLCholesterol, LDLDietary FiberInsulinTriglyceridesBASBile acid sequestrantsHDL-CHigh density lipoprotein cholesterolLDL-CLipoprotein Insulin Resistance IndexLIRILow density lipoprotein cholesterolTCTGTotal cholesterolTriglyceridesα-cyclodextrin

Identifiers

PMID27405337
PMCPMC4941029
OpenAlexW2471349002

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.