A Two-part Study of Lembas Edge Evaluating Tolerability and Postprandial Glycemic Control
In plain words A study of alpha-Galactosidase in people 18 and older, run by Lembas. It plans to enroll about 35 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older; healthy volunteers accepted. Conditions: Postprandial Glycemic Control; Prediabetic Overweight and Obese Adults.
- Males \& females 18 years and older
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g.
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
21 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Low dose alpha-galactosidase-derived peptide; Medium dose alpha-galactosidase-derived peptide; High dose alpha-galactosidase-derived peptide; Placebo
Registered summary
The goal of part 1 of this clinical trial is to investigate the tolerability of Lembas Edge in healthy adults. The objective of Part 2 of this study is to investigate the efficacy of Lembas Edge on postprandial glycemic control in prediabetic overweight and obese adults. The main questions it aims to answer are: * What is the tolerability of Lembas Edge? * What is the efficacy of Lembas Edge on postprandial glycemic control? Researchers will compare Lembas Edge to placebo to see its effects. Participants will be asked to: * Provide blood samples. The full summary is on the listing.
Where, as registered
No US site; Canada (1).