The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Quest Nutrition LLC
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01910558
First received: July 22, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

Saturated fat leading to elevated low density lipoprotein (LDL) cholesterol is considered a cardiovascular risk factor. The properties associated with α- cyclodextrin, allow it to selectively reduce saturated fat and calories which will have a medically beneficial effect on LDL cholesterol and obesity. The purpose of the research is to evaluate this effect of α- cyclodextrin. It is hypothesized that alpha cyclodextrin supplementation will increase fecal fat on a high saturated fat diet compared to the same diet supplemented with a digestible carbohydrate control


Condition Intervention
Obesity
Cardiovascular Disease
Dietary Supplement: Alpha-cyclodextrin and digestible starch
Dietary Supplement: Alpha-cyclodextrin
Dietary Supplement: Digestible starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Oral Alpha-Cyclodextrin on Fecal Fat Excretion

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Fecal Fat Excretion compared at three time periods. [ Time Frame: Assessment of change at each fourth, fifth, and sixth day of each feeding period. ] [ Designated as safety issue: No ]
    Each subject will consume a different product every six consecutive days which is called a feeding period. On the fourth, fifth, and sixth day of each feeding period, a comparison of fat excretion will be measured through a stool sample. These feeding periods will occur for three consecutive six days totaling eighteen days of feeding. 6+6+6=18


Secondary Outcome Measures:
  • Adverse events [ Time Frame: The duration of the 18 days in the study. ] [ Designated as safety issue: Yes ]
    Subjects will be asked if they experienced any adverse events. All adverse events will be recorded and evaluated.


Estimated Enrollment: 9
Study Start Date: October 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alpha-cyclodextrin and digestible starch
Supplementation with three grams alpha cyclodextrin with three grams of digestible starch
Dietary Supplement: Alpha-cyclodextrin
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin
Experimental: Alpha-cyclodextrin
Supplementation with six grams of alpha-cyclodextrin
Dietary Supplement: Alpha-cyclodextrin and digestible starch
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch
Placebo Comparator: Digestible Starch
Supplementation with six grams of digestible starch
Dietary Supplement: Digestible starch
Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch

Detailed Description:

Alpha-cyclodextrin which functions as a soluble dietary fiber, has been shown to a form a stable emulsion with dietary fat in the ratio of 1:9, with a higher affinity for saturated fat compared to unsaturated fat. In humans, supplementation with α-cyclodextrin has been shown to lead to a significant weight loss regardless of whether energy intake was maintained or increased.The aim of this study is to evaluate the results of a 72 hour fecal fat test using stool markers on the last three days of each of three six-day feeding periods. Subjects will be served a weight maintaining diet containing 40% fat (of which 40% will be saturated), 30% protein and 30% carbohydrate for 18 days. Subjects will also consume 1 gram alpha cyclodextrin with 1 gram of starch, 2 grams of alpha cyclodextrin, or 2 grams of starch in capsule form before breakfast, lunch, and dinner every day in each of the three six-day feeding periods. At this dose, alpha-cyclodextrin is recognized as safe by the FDA. All stools will be collected over a 72 hour period at the end of each feeding period and analyzed for fecal fat excretion.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 20 and 30 kg/m2 inclusive
  • Weight ≥ 65 kg for females, and ≥ 55 kg for males

Exclusion Criteria:

  • Pregnant or nursing.
  • Diabetes Mellitus
  • Any medication to reduce lipids
  • History of gastrointestinal surgery, except for cholecystectomy or appendectomy
  • History of malabsorption
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01910558

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Quest Nutrition LLC
Investigators
Principal Investigator: Frank L Greenway, M.D. Pennington Biomedical Research Center
  More Information

Publications:
Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01910558     History of Changes
Other Study ID Numbers: Alpha-cyclodextrin
Study First Received: July 22, 2013
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Alpha-cyclodextrin
Dietary fiber
Fecal fat
Saturated fat

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014