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

This study has been terminated.
(Stopped due to a non-safety-related issue with the beverage (test vehicle).)
Sponsor:
Information provided by:
Cargill
ClinicalTrials.gov Identifier:
NCT00820807
First received: January 8, 2009
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Insulin Resistance
Other: Novel dietary fiber
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cargill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean changes in blood HbA1c values from baseline to end of study [ Time Frame: 0 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean changes from baseline in waist circumference at selected visits [ Time Frame: 0 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00820807

Locations
United States, Kentucky
Louisville Metabolic and Atherosclerosis Research Center (LMARC)
Louisville, Kentucky, United States, 40213
Sponsors and Collaborators
Cargill
Investigators
Principal Investigator: Harold E Bays, MD, FACP Louisville Metabolic and Atherosclerosis Research Center
  More Information

Publications:

Responsible Party: Harold E. Bays, MD, FACP/ Medical Director and President, Louisville Metabolic and Atherosclerosis Research Center (LMARC)
ClinicalTrials.gov Identifier: NCT00820807     History of Changes
Other Study ID Numbers: CFIS-08-003
Study First Received: January 8, 2009
Last Updated: June 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Cargill:
dietary fiber
fiber
insulin sensitivity
insulin resistance
glucose metabolism

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014