Effects of Novel Fiber on Glucose Metabolism and Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by:
Cargill
ClinicalTrials.gov Identifier:
NCT01375803
First received: June 16, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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
Dietary Supplement: 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

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, 6, 9, 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, 6, 9, 12 weeks ] [ Designated as safety issue: No ]
  • Mean changes in blood HbA1c values from baseline to end of study [ Time Frame: 0, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean changes from baseline to end of study in HOMA [ Time Frame: 0, 6, 9, 12 weeks ] [ Designated as safety issue: No ]
  • Percentage change and absolute change from baseline in body weight [ Time Frame: 0, 3, 6, 9, 12 weeks ] [ Designated as safety issue: No ]
  • Mean changes from baseline in waist circumference [ Time Frame: 0, 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, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
3g/day
Dietary Supplement: Novel dietary fiber
oral consumption in beverage
Experimental: 2
6g/day
Dietary Supplement: 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 70 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: at least 30 and no more than 70 years at randomization into this trial
  • BMI: 25-40 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 >250 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375803

Locations
United States, Kentucky
Louisville Metabolic and Atherosclerosis Research Center
Louisvile, Kentucky, United States, 40213
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
Cargill
Investigators
Principal Investigator: Harold E Bays, MD, FACP Louisville Metabolic and Atherosclerosis Research Center
Principal Investigator: Dale R Wilson, MD, CCFP(EM), FCFP KGK Synergize Inc.
  More Information

Publications:
Responsible Party: Anne Franck, PhD, Cargill Incorporated
ClinicalTrials.gov Identifier: NCT01375803     History of Changes
Other Study ID Numbers: CFIS-09-001
Study First Received: June 16, 2011
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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014