Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
NCT ID: NCT03002168
Sponsor Protocol Number: 16-005006
About this study
The Investigator hypothesizes that the currently used dose of dietary ingredient alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared with placebo. The proposed studies will address the degree to which α-CD increases dietary fat loss. The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester, Minnesota.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Healthy weight stable individuals (defined as a Body Mass Index (BMI) of ≥18.5 and <27, and stable for at least the preceding two months from Screening).
- Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the trial and agrees not to donate sperm or ova, for the duration of the study
- Subjects ≥18 and ≤60 years of age at screening
- Consistent regular bowel movement (defined as between 3 times a day, to 1 time per day)
- Provide Informed Consent
- Willing and able to complete study procedures within the study timelines
- Adequate renal function: serum creatinine less than 1.5 x Upper Limit of Normal (ULN)
- Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN, unless Gilbert's syndrome has previously been confirmed for the subject
- Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm^3, absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 9 gram/deciLiter, and platelets ≥ 100,000/mm^3
- Evidence of chronic pancreatitis
- Evidence of irritable bowel syndrome (medical or self-diagnosed)
- Previous gallbladder surgery
- Use of enemas and/or suppositories within 30 days of Screening
- Consuming ≥ 375 mg of caffeine per day (equivalent to 5 serves of 1 oz. restaurant style espresso per day)
- History of febrile illness within 5 days prior to Screening
- Evidence or history of substance or alcohol abuse
- History of major depression, bipolar disorder, or schizophrenia (per DSM4 criteria; Diagnostic and Statistical Manual of Mental Disorders)
- Current use of prescription or non-prescription weight loss products (≥ 2 week washout period is required to become eligible)
- Smoking ≥ 20 cigarettes (~one pack) per week
- Significant dietary restrictions (incl. vegan, vegetarian diets and any subject not prepared to consume any of the standardized food/s)
- Evidence of an active eating disorder (incl. anorexia nervosa, bulimia, and/or obsessive compulsive disorders)
- Use of other investigational agent(s at the time of enrollment, or within 30 days or five half-lives of enrollment, whichever is longer
- Pregnant or lactating
- Current use of any medication known to affect gut motility
- History of malignancy, treated or untreated, within the past five years, with the exception of non-melanoma skin cancer and cervical carcinoma in situ
- A known history of hypersensitivity to any of the α-CD ingredients
- Any other health condition that would preclude participation in the study in the judgment of the principal investigator
Publications are currently not available