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Trial record 13 of 7500 for:    Area Under Curve

A Randomized, Controlled, Crossover Study to Assess the Glucose and Insulin Excursions of a Test Fiber

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ClinicalTrials.gov Identifier: NCT03239288
Recruitment Status : Completed
First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Collaborator:
Biofortis Clinical Research, Inc.
Information provided by (Responsible Party):
Cargill

Brief Summary:
The objective of this trial is to evaluate the postprandial glucose and insulin responses to replacing digestible carbohydrates with resistant starch type 4 (RS4) in a baked product in healthy men and women. A randomized, double-blinded cross-over study will be conducted comparing two foods (a reference food and a test food). The primary outcome variable will be the incremental area under the curve (iAUC) for capillary glucose from pre-product consumption (average of t = -15 and -5 min) to 120 min (iAUC0-120 min). This study will provide substantiation for a beneficial reduction in glycemic response followed by the consumption of the active product containing an efficacious dose of resistant starch type 4 (RS4).

Condition or disease Intervention/treatment Phase
Healthy Other: Control digestible carbohydrate Other: Test resistant starch type 4 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Randomized, controlled, double-blind, crossover trial that includes one screening visit and two test visits separated by a washout period of 4-7 days. At Visit 1 (day -7), subjects will provide informed consent and undergo screening assessments. Test day instructions will also be provided.

At Visit 2 (day 0), subjects will arrive at the clinic fasted (10-14 h, water only, anchored to the t = -15 min blood draw), to undergo clinic visit procedures. Eligible subjects will be randomly assigned to a randomization sequence and will undergo the glycemic and insulinemic response test with blood glucose concentrations assessed via capillary measurement and insulin concentrations assessed via venous measurement.

At Visit 3 (day 7), subjects will return to the clinic for clinic visit procedures. Subjects will then crossover to the next study product in their test sequence and repeat the glycemic/insulinemic response test described above for Visit 2.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Controlled, Crossover Study to Assess the Glucose and Insulin Excursions of a Test Fiber
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : July 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Placebo Comparator: Control digestible carbohydrate
Control baked breakfast bar
Other: Control digestible carbohydrate
Single serving of control product

Experimental: Test resistant starch type 4
Test baked breakfast bar
Other: Test resistant starch type 4
Single serving of test product




Primary Outcome Measures :
  1. Incremental area under the curve (iAUC) for glucose [ Time Frame: Capillary glucose test at t = -15 and -5 and at t = 15, 30, 45, 60, 90, and 120 min after product consumption ]
    Incremental area under the curve (iAUC) for capillary glucose across 2h


Secondary Outcome Measures :
  1. Maximum concentration (Cmax) for glucose [ Time Frame: 0-120 minutes ]
    Maximum concentration for capillary glucose within the tested time interval

  2. Time to maximum concentration (tmax) for glucose [ Time Frame: 0-120 minutes ]
    Time to maximum concentration for capillary glucose within the tested time interval

  3. Incremental area under the curve (iAUC) for insulin [ Time Frame: Venous insulin test at t = -15 and -5 and at t = 15, 30, 45, 60, 90, and 120 min after product consumption ]
    Incremental area under the curve (iAUC) for venous insulin across 2h

  4. Maximum concentration (Cmax) for insulin [ Time Frame: 0-120 minutes ]
    Maximum concentration for capillary venous insulin within the tested time interval

  5. Time to maximum concentration (tmax) for insulin [ Time Frame: 0-120 minutes ]
    Time to maximum concentration for venous insulin within the tested time



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is a generally healthy male or female, 20-45 years, inclusive.
  • Body mass index (BMI) 18.5 to 27.0 kg/m2, inclusive, at Visit 1 (day -7).
  • Subject has a rating of 7 to 10 on the Vein Access Scale at Visit 1 (day -7).
  • If a smoker, subject has no plans to change smoking habits during the study period and is able to abstain from tobacco products at least 1 hour prior to and during each test visit.
  • Normally active and judged by the Clinical Investigator/Medical Monitor to be in general good health on the basis of medical history.
  • Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during test visits.
  • Subject is willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial.
  • Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the Clinical Investigator/Medical Monitor.
  • Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator/Medical Monitor on the basis of medical history and routine laboratory test results.
  • Willing to maintain current use of vitamins, minerals, and other supplements throughout the trial. On test days, subject agrees not to take any vitamins, minerals, or other dietary supplements until dismissal from the clinic. Failure to comply will result in a rescheduled test visit.
  • For females on oral contraceptives, the subject must be on a stable dose of oral contraceptives (defined as same dose for the past 90 d prior to Visit 1; day -7).

Exclusion Criteria:

  • Fasting blood glucose ≥110 mg/dL at Visit 1 (day -7) or diagnosed diabetes mellitus. No retest will be allowed.
  • History or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, gastrointestinal (including but not limited to inflammatory bowel diseases, such as Crohn's disease, ulcerative colitis, or other gastrointestinal conditions that may interfere with the absorption of the study product), endocrine, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders.
  • Subject has a history of bariatric surgery for weight reducing purposes.
  • Subject has had a weight loss or gain >4.5 kg in the 3 months prior to Visit 1 (day -7).
  • Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at Visit 1 (day -7).
  • History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
  • Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Clinical Investigator/Medical Monitor) and any intervention (e.g., antibiotic therapy) has been completed at least 5 d prior to testing.
  • Has used medications known to influence carbohydrate metabolism, including, but not limited to, protease inhibitors, antipsychotics, adrenergic receptor blockers, diuretics, thiazolidinediones, metformin, and systemic corticosteroids, within 4 weeks of Visit 1 (stable doses of vitamin and mineral supplements are allowed).
  • Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 4 weeks prior to Visit 1 (day -7).
  • Subject has experienced any major trauma or surgical event within three months of Visit 1 (day -7).
  • Recent (within 4 weeks of Visit 1) use of antibiotics.
  • Recent history of (within 12 months of Visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse define as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
  • Subject has a known food allergy or intolerance, or sensitivity to any ingredients in the study products.
  • Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Clinical Investigator/Medical Monitor.
  • Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the stable use of a medically approved form of contraception throughout the study period.
  • Exposure to any non-registered drug product within 30 d prior to Visit 1 (day - 7).
  • Individual has a condition the Clinical Investigator/Medical Monitor believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239288


Locations
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United States, Illinois
Biofortis Clinical Research
Addison, Illinois, United States, 60101
Sponsors and Collaborators
Cargill
Biofortis Clinical Research, Inc.
Investigators
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Principal Investigator: Kathleen M Kelley, MD Biofortis Clinical Research, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cargill
ClinicalTrials.gov Identifier: NCT03239288     History of Changes
Other Study ID Numbers: BIO-1706
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cargill:
Fiber
Postprandial glucose
Insulin
Resistant Starch Type 4
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs