NCT01910558

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

Same day

First QC Date

July 22, 2013

Last Update Submit

April 25, 2016

Conditions

ObesityCardiovascular Disease

Keywords

Alpha-cyclodextrinDietary fiberFecal fatSaturated fat

Outcome Measures

Primary Outcomes (1)

  • Fecal Fat Excretion compared at three time periods.

    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

    Assessment of change at each fourth, fifth, and sixth day of each feeding period.

Secondary Outcomes (1)

  • Adverse events

    The duration of the 18 days in the study.

Study Arms (3)

Alpha-cyclodextrin and digestible starch

ACTIVE COMPARATOR

Supplementation with three grams alpha cyclodextrin with three grams of digestible starch

Dietary Supplement: Alpha-cyclodextrin

Alpha-cyclodextrin

EXPERIMENTAL

Supplementation with six grams of alpha-cyclodextrin

Dietary Supplement: Alpha-cyclodextrin and digestible starch

Digestible Starch

PLACEBO COMPARATOR

Supplementation with six grams of digestible starch

Dietary Supplement: Digestible starch

Interventions

Alpha-cyclodextrin and digestible starchDIETARY_SUPPLEMENT

Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch

Alpha-cyclodextrin
Alpha-cyclodextrinDIETARY_SUPPLEMENT

Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin

Alpha-cyclodextrin and digestible starch
Digestible starchDIETARY_SUPPLEMENT

Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch

Digestible Starch

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnant or nursing.
  • Diabetes Mellitus
  • Any medication to reduce lipids
  • History of gastrointestinal surgery, except for cholecystectomy or appendectomy
  • History of malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

  • Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011 Jun;19(6):1200-4. doi: 10.1038/oby.2010.280. Epub 2010 Dec 2.

    PMID: 21127475BACKGROUND

  • Grunberger G, Jen KL, Artiss JD. The benefits of early intervention in obese diabetic patients with FBCx: a new dietary fibre. Diabetes Metab Res Rev. 2007 Jan;23(1):56-62. doi: 10.1002/dmrr.687.

    PMID: 17013969BACKGROUND

  • Artiss JD, Brogan K, Brucal M, Moghaddam M, Jen KL. The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats. Metabolism. 2006 Feb;55(2):195-202. doi: 10.1016/j.metabol.2005.08.012.

    PMID: 16423626BACKGROUND

MeSH Terms

Conditions

ObesityCardiovascular Diseases

Interventions

alpha-cyclodextrin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frank L Greenway, M.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 29, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

US(1)