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CompletedNCT01375803Updated Jun 17, 2011

Effects of Novel Fiber on Glucose Metabolism and Insulin Sensitivity

An interventional study of Novel dietary fiber and Novel dietary fiber in Insulin Resistance, sponsored by Cargill. Completed at 2 sites in 2 countries. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-17.

Sponsored by Cargill · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Insulin Resistance

Keywords

  • dietary fiber
  • fiber
  • insulin sensitivity
  • insulin resistance
  • glucose metabolism
03

In context

Insulin Resistance

1,959 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.

This study's enrollment of 45 is above the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Cargill is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    1

    3g/day

    Dietary Supplement: Novel dietary fiber

  • Experimental
    2

    6g/day

    Dietary Supplement: Novel dietary fiber

  • Placebo comparator
    Placebo beverage

    0g/day

    Other: Placebo

Interventions

  • Dietary supplementNovel dietary fiber

    oral consumption in beverage

  • Dietary supplementNovel dietary fiber

    Oral consumption in beverage

  • OtherPlacebo

    Oral consumption in beverage

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Mean changes in blood HbA1c values from baseline to end of study

    Time frame: 0, 12 weeks

Secondary outcomes

  1. Mean changes from baseline to end of study in HOMA

    Time frame: 0, 6, 9, 12 weeks

  2. Percentage change and absolute change from baseline in body weight

    Time frame: 0, 3, 6, 9, 12 weeks

  3. Mean changes from baseline in waist circumference

    Time frame: 0, 12 weeks

  4. Mean changes in total body fat, lean tissue and abdominal fat as determined by DEXA [distribution or absolute changes]

    Time frame: 0, 12 weeks

07

Study locations

2 sites
  • Louisville Metabolic and Atherosclerosis Research Center
    Louisvile, Kentucky 40213, United States
  • KGK Synergize Inc.
    London, Ontario N6A 5R8, Canada
08

References and documents

Publications

  • Weickert MO, Mohlig M, Schofl C, Arafat AM, Otto B, Viehoff H, Koebnick C, Kohl A, Spranger J, Pfeiffer AF. Cereal fiber improves whole-body insulin sensitivity in overweight and obese women. Diabetes Care. 2006 Apr;29(4):775-80. doi: 10.2337/diacare.29.04.06.dc05-2374. PubMed 16567814 ↗
  • Lu ZX, Walker KZ, Muir JG, Mascara T, O'Dea K. Arabinoxylan fiber, a byproduct of wheat flour processing, reduces the postprandial glucose response in normoglycemic subjects. Am J Clin Nutr. 2000 May;71(5):1123-8. doi: 10.1093/ajcn/71.5.1123. PubMed 10799374 ↗
  • Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003 Oct;22(5):331-9. doi: 10.1080/07315724.2003.10719316. PubMed 14559925 ↗
  • Behall KM, Scholfield DJ, Hallfrisch J. Comparison of hormone and glucose responses of overweight women to barley and oats. J Am Coll Nutr. 2005 Jun;24(3):182-8. doi: 10.1080/07315724.2005.10719464. PubMed 15930484 ↗
  • Jenkins AL, Jenkins DJ, Zdravkovic U, Wursch P, Vuksan V. Depression of the glycemic index by high levels of beta-glucan fiber in two functional foods tested in type 2 diabetes. Eur J Clin Nutr. 2002 Jul;56(7):622-8. doi: 10.1038/sj.ejcn.1601367. PubMed 12080401 ↗
  • Keenan JM, Goulson M, Shamliyan T, Knutson N, Kolberg L, Curry L. The effects of concentrated barley beta-glucan on blood lipids in a population of hypercholesterolaemic men and women. Br J Nutr. 2007 Jun;97(6):1162-8. doi: 10.1017/S0007114507682968. Epub 2007 Apr 20. Erratum In: Br J Nutr. 2007 Aug;98(2):445. PubMed 17445284 ↗
  • Bays H, Frestedt JL, Bell M, Williams C, Kolberg L, Schmelzer W, Anderson JW. Reduced viscosity Barley beta-Glucan versus placebo: a randomized controlled trial of the effects on insulin sensitivity for individuals at risk for diabetes mellitus. Nutr Metab (Lond). 2011 Aug 16;8:58. doi: 10.1186/1743-7075-8-58. PubMed 21846371 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01375803
Lead sponsor
Cargill
First posted
Jun 17, 2011
Start date
Jun 2009
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Jun 17, 2011

Study contacts

Harold E Bays, MD, FACP
principal investigator · Louisville Metabolic and Atherosclerosis Research Center
Dale R Wilson, MD, CCFP(EM), FCFP
principal investigator · KGK Science Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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