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OpenTrials
Completed

NCT Number: NCT00682916

Compare Effects of a Soluble Fiber on Weight and Blood Cholesterol

Obesity and type 2 diabetes have clearly been linked together and identified as epidemics in much of the developed world. Historically several different dietary fibers have been used as means of reducing body weight and the related development of type 2 diabetes. These studies have generated mixed, if not inconsistent, results suggesting that none of these fibers promise a solution to either of these two conditions. We are proposing to investigate the effects of including a new soluble fiber, a-cyclodextrin, FBCx® (to be called Y288 in this study), into the diet of adult overweight volunteers.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis

Sacramento, California, 95817, United States

About this study

The overall aim is to investigate the effectiveness of a soluble dietary fiber, FBCx®, on weight loss and/or weight management, and blood lipid levels in overweight humans.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 30 men and 30 women
  • Age 18- 65 years
  • BMI 25.0 - 32.0 Kg/m²
  • fasting glucose <126 mg/dL
  • Blood pressure < 140/85 mm Hg. Hypertension on stable drug regimen using 2 or fewer antihypertensives will be acceptable.
  • Total plasma cholesterol <240 mg/dl, LDL-cholesterol <160 and triglycerides <400 mg/dl. Hyperlipidemia on a stable medication regimen using single anti-hyperlipidemic drug acceptable.

Exclusion criteria

  • Pregnant women, women who plan to become pregnant during the study period
  • Women who have given birth within the previous 12 months
  • Lactating women
  • History or presence of Type 2 diabetes; kidney disease; (creatinine >1.4); liver disease (X2 fold increase in AST or ALT); gout; cancer; untreated thyroid disease; gastrointestinal disease; other metabolic diseases or malabsorption syndromes
  • Habitual low-fat intake (less than 20%)
  • History of eating disorder
  • Subjects who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program
  • Use of prescription or over-the counter anti-obesity medications or supplements (phenylpropanolamine, ephedrine, caffeine) for at least 6 months prior of study.
  • Subjects with pacemakers will not participate in bioimpedance studies but will go through all the other testing.

Treatment and study plan

Y288

Dietary Supplement

Subjects will take 2 tablets per fat containing meal, 3 times a day, within one hour of consuming the meal

Other names: FBCx®

Primary outcomes

  1. without any altering of dietary habits or exercise routine, individuals shall lose or maintain body weight during the active phase as compared to the placebo phase.

    Time frame: 4 weeks

Secondary outcomes

  1. blood lipid levels during the active phase will be improved relative to the placebo phase.

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

CCRC: FBCx® And Body Weight Regulation in Overweight Humans

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 23, 2008
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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