Effects of Novel Fiber on Glucose Homeostasis in Individuals at Risk for Diabetes

June 16, 2011 updated by: Cargill

Novel Fiber Effects on Glucose Metabolism and Insulin Sensitivity for Individuals at High Risk for Diabetes: a Randomized, Placebo-controlled, Double-blind, Parallel Group Clinical Trial

This study will critically evaluate the effects of a novel dietary fiber administered to subjects at high risk for developing diabetes to determine if this intervention will improve insulin sensitivity compared to control product administration and, thus, decrease risk for developing diabetes.

The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening) compared to consumption of the control product.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Louisville Metabolic and Atherosclerosis Research Center (LMARC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female of any racial/ethnic group; able to read, comprehend, and write English at a sufficient level to complete study-related materials
  • Age: >30 and <65 years at randomization into this trial
  • BMI: 25-35 kg/m2 at randomization into this trial
  • Fasting blood glucose: 95-140 mg/dl (for those with glucose 95-99mg/dl, must have history of gestational diabetes or first degree relative (parent or sibling) with history of diabetes; for those with glucose 100-125 mg/dl, will be enrolled as the primary target for recruitment; for those with glucose 126-140 mg/dl (asymptomatic diabetes), must not have prior diagnosis of diabetes and must not have prior treatment/pharmacotherapy for diabetes)
  • Good general health as evidenced by the medical history
  • Blood chemistry and urinalysis results within normal ranges or within an acceptable range determined by the physician on site and/or in consultation with the Medical Monitor
  • Available and willing to participate in the study for up to 15 weeks
  • Willing to follow a weight-maintaining Lifestyle diet throughout the 12 week trial, maintain physical activity patterns at baseline levels throughout the study period, and not add new exercise routines, dietary supplements, vitamins or other unusual food products
  • Willing to consume two 16 oz beverages every day with meals for 12 weeks and able to transport the test article

Exclusion Criteria:

  • Presence of any condition the Investigator believes would interfere with subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk
  • Food allergy or sensitivity to any of the ingredients in the study product (e.g. Gluten sensitivity, celiac disease)
  • Participation in another clinical trial that might interfere with this trial or exposure to any investigational agent within 30 days prior to first visit
  • History of diabetes (subjects with a prior history of gestational diabetes may be enrolled if they had no pharmacologic treatment for diabetes since pregnancy)
  • Treatment for diabetes or a related condition (e.g., polycystic ovary syndrome) with metformin, an oral agent, or insulin or other injections used for diabetes management
  • Uncontrolled hypertension (i.e., systolic blood pressure >160 mm Hg, or a diastolic blood pressure >95 mmHg based on an average of 3 readings sitting)
  • Fasting serum triglyceride value >200 mg/dl (since changes in triglyceride values can affect glucose homeostasis)
  • Untreated hypothyroidism with a TSH > 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit
  • Recent history of weight loss (>4 kg in the past 3 months) or a significant variation in weight (>4 kg in the past 3 months, for example, due to a medical condition such as pregnancy, or hormonal therapy)
  • Use of medications or herbal remedies for weight loss (e.g., sibutramine, orlistat, amphetamines, phentermine, and ma huang) or use of these substances within the past 3 months
  • Current or recent history (past 12 months) of drug, alcohol or chemical abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor)
  • Pregnant, breast-feeding or female of child-bearing potential who is unwilling to commit to the use of a medically approved form of contraception throughout the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
3g/day
Other: Novel dietary fiber
oral consumption in beverage
Experimental: 2
6g/day
Other: Novel dietary fiber
oral consumption in beverage
Placebo Comparator: Placebo beverage
0g/day
Other: Placebo
oral consumption in beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean changes in fasting and post-glucose administration values for plasma glucose from baseline to end of study
Time Frame: 0 weeks, 6 weeks, 9 weeks,12 weeks
0 weeks, 6 weeks, 9 weeks,12 weeks
Mean changes in fasting and post-glucose administration values for plasma insulin from baseline to end of study
Time Frame: 0 weeks, 6 weeks, 9 weeks,12 weeks
0 weeks, 6 weeks, 9 weeks,12 weeks
Mean changes in blood HbA1c values from baseline to end of study
Time Frame: 0 weeks, 12 weeks
0 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean changes from baseline to end of study in HOMA, a measure of insulin sensitivity
Time Frame: 0 weeks, 6 weeks, 9 weeks,12 weeks
0 weeks, 6 weeks, 9 weeks,12 weeks
Mean changes from baseline for fasting serum total cholesterol, HDL-cholesterol, LDL-cholesterol and triglyceride values at 6 and 12 weeks
Time Frame: 0 weeks, 6 weeks, 12 weeks
0 weeks, 6 weeks, 12 weeks
Percentage change and absolute change from baseline in body weight at each treatment visit
Time Frame: 0 weeks, 3 weeks, 6 weeks, 9 weeks, 12 weeks
0 weeks, 3 weeks, 6 weeks, 9 weeks, 12 weeks
Mean changes from baseline in waist circumference at selected visits
Time Frame: 0 weeks, 12 weeks
0 weeks, 12 weeks
Mean changes in total body fat, lean tissue and abdominal fat as determined by DEXA [distribution or absolute changes]
Time Frame: 0 weeks, 12 weeks
0 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cargill

Investigators

  • Principal Investigator: Harold E Bays, MD, FACP, Louisville Metabolic and Atherosclerosis Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFIS-08-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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