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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014