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

Abstract

Summary The prevalence of pre‐diabetes and of type 2 diabetes mellitus is increasing. Preventing disease progression is important to improve outcomes. Natural products are becoming popular alternatives to pharmaceutical products for preventative health and treatment of disease; however, the evidence to support the use of natural alternatives for pre‐diabetes and type 2 diabetes is lacking. Two such natural medicines include alpha‐cyclodextrin (marketed as FBCx), a fibre derived from corn starch that has been found to bind triglycerides in the intestines to prevent its absorption, aiding weight maintenance and lipid control, and hydrolysed ginseng extract (marketed as GINST15), a formula containing high amounts of Compound K, a metabolite of ginsenosides thought to be an active ingredient contributing to the anti‐hyperglycaemic effects of ginseng. This paper describes the rationale and design of a 12‐month randomized controlled trial to investigate the metabolic effects of these two products in people with pre‐diabetes and overweight or obesity. A total of 400 participants will be randomized to one of four groups (FBCx + GINST15, FBCx + placebo, placebo + GINST15, placebo + placebo) for 6 months, followed by 6 months of follow‐up. Participants will also receive lifestyle advice for healthy eating and weight loss. Data collected during the trial will include weight, waist circumference, body composition and blood pressure. Blood samples will also be collected to measure lipid profile and glycaemia. If the products are found to improve lipid and glucose levels, it will provide evidence for their use in people with pre‐diabetes to help reduce the risk of progression to type 2 diabetes.

Effects of α-Cyclodextrin on Cholesterol Control and Hydrolyzed Ginseng Extract on Glycemic Control in People With Prediabetes

“…Participants met with a study dietitian monthly and received personalized advice for prevention of type 2 diabetes, focusing on a healthy, hypocaloric diet, moderate intensity exercise, and behavior management. 19 Outcomes Anthropometric, medical, and behavioral outcome measures were collected before, during, and after the intervention; details have been published previously. 19 The primary outcomes of total cholesterol and FPG and the secondary outcomes of weight, HbA 1c , low-density lipoprotein (LDL) cholesterol, and triglycerides were measured at the screening or baseline visit, and at the 6-month visit (end of intervention period).…”

“…19 Outcomes Anthropometric, medical, and behavioral outcome measures were collected before, during, and after the intervention; details have been published previously. 19 The primary outcomes of total cholesterol and FPG and the secondary outcomes of weight, HbA 1c , low-density lipoprotein (LDL) cholesterol, and triglycerides were measured at the screening or baseline visit, and at the 6-month visit (end of intervention period). Safety measurements assessed over the course of the trial included routine pathology tests and clinical vital signs.…”

“…Safety measurements assessed over the course of the trial included routine pathology tests and clinical vital signs. 19 Adverse events were monitored at every visit. 19…”

“…The trial protocol, including a full list of the eligibility criteria, has been published previously (Supplement 1). 19…”

“…. Although all participants had external results meeting the diagnosis of prediabetes within 6 months of screening,19 only 226 participants (56%) met the guidelines for prediabetes on the basis of blood samples taken at their screening visit. FPG ranged from 74 to 141 mg/dL (mean [SD], 97…”