AzTrials
AzTrials

Insulin ResistanceNCT01375803

Effects of Novel Fiber on Glucose Metabolism and Insulin Sensitivity

A study testing Novel dietary fiber in people with Insulin Resistance, run by Cargill at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Resistance
What is being tested?
Novel dietary fiber
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
2 sitesin 2 countries
Study dates
Jun 2009to Aug 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Louisville Metabolic and Atherosclerosis Research Center

    Louisvile, Kentucky, 40213

Other trials in United States

Canada1 site

  • KGK Synergize Inc.

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: Novel Fiber Effects on Glucose Metabolism and Insulin Sensitivity for Individuals at High Risk for Diabetes

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.

Being tested
Novel dietary fiber, Placebo
Keywords
dietary fiber, fiber, insulin sensitivity, insulin resistance, glucose metabolism
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Novel dietary fiberDietary supplement

    oral consumption in beverage

  • Novel dietary fiberDietary supplement

    Oral consumption in beverage

  • PlaceboOther

    Oral consumption in beverage

Study groups in NCT01375803
Study groupRoleWhat they receive
1Experimental3g/day
Receives: Dietary Supplement: Novel dietary fiber
2Experimental6g/day
Receives: Dietary Supplement: Novel dietary fiber
Placebo beveragePlacebo comparator0g/day
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean changes in fasting and post-glucose administration values for plasma glucose from baseline to end of study

    Measured: 0, 6, 9, 12 weeks

  2. Mean changes in fasting and post-glucose administration values for plasma insulin from baseline to end of study

    Measured: 0, 6, 9, 12 weeks

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

    Measured: 0, 12 weeks

Secondary outcomes (4)

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

    Measured: 0, 6, 9, 12 weeks

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

    Measured: 0, 3, 6, 9, 12 weeks

  3. Mean changes from baseline in waist circumference

    Measured: 0, 12 weeks

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

    Measured: 0, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2011 (estimated)
  2. Study startJun 2009
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01375803
Sponsor's protocol ID
CFIS-09-001
Status last verified
Jun 2011
First submitted
16 Jun 2011
Last updated
17 Jun 2011
Results posted
No
Data monitoring committee
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Novel dietary fiber in people with Insulin Resistance, run by Cargill at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01375803, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in