Clinical trial NCT00820807: Effects of Novel Fiber on Glucose Homeostasis in Individuals at Risk for Diabetes
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insulin Resistance
Keywords: dietary fiber
fiber
insulin sensitivity
insulin resistance
glucose metabolism
Lead sponsor: Cargill
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Mean changes in fasting and post-glucose administration values for plasma glucose from baseline to end of study
timeFrame: 0 weeks, 6 weeks, 9 weeks,12 weeks
measure: Mean changes in fasting and post-glucose administration values for plasma insulin from baseline to end of study
timeFrame: 0 weeks, 6 weeks, 9 weeks,12 weeks
measure: Mean changes in blood HbA1c values from baseline to end of study
timeFrame: 0 weeks, 12 weeks
Secondary outcomes:
measure: Mean changes from baseline to end of study in HOMA, a measure of insulin sensitivity
timeFrame: 0 weeks, 6 weeks, 9 weeks,12 weeks
measure: Mean changes from baseline for fasting serum total cholesterol, HDL-cholesterol, LDL-cholesterol and triglyceride values at 6 and 12 weeks
timeFrame: 0 weeks, 6 weeks, 12 weeks
measure: Percentage change and absolute change from baseline in body weight at each treatment visit
timeFrame: 0 weeks, 3 weeks, 6 weeks, 9 weeks, 12 weeks
measure: Mean changes from baseline in waist circumference at selected visits
timeFrame: 0 weeks, 12 weeks
measure: Mean changes in total body fat, lean tissue and abdominal fat as determined by DEXA [distribution or absolute changes]
timeFrame: 0 weeks, 12 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Louisville Metabolic and Atherosclerosis Research Center (LMARC)
state: Kentucky
Study officials:
affiliation: Louisville Metabolic and Atherosclerosis Research Center
name: Harold E Bays, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
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