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

NCT03239288 | Completed

• 1 other identifier: BIO-1706
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Fiber; Postprandial glucose; Insulin; Resistant Starch Type 4

Outcome Measures

Primary Outcomes (1)

• Incremental area under the curve (iAUC) for glucose

  Incremental area under the curve (iAUC) for capillary glucose across 2h

  Capillary glucose test at t = -15 and -5 and at t = 15, 30, 45, 60, 90, and 120 min after product consumption

Secondary Outcomes (5)

• Maximum concentration (Cmax) for glucose

  0-120 minutes

• Time to maximum concentration (tmax) for glucose

  0-120 minutes

• Incremental area under the curve (iAUC) for insulin

  Venous insulin test at t = -15 and -5 and at t = 15, 30, 45, 60, 90, and 120 min after product consumption

• Maximum concentration (Cmax) for insulin

  0-120 minutes

• Time to maximum concentration (tmax) for insulin

  0-120 minutes

Study Arms (2)

Control digestible carbohydrate

PLACEBO COMPARATOR

Control baked breakfast bar

Other: Control digestible carbohydrate

Test resistant starch type 4

EXPERIMENTAL

Test baked breakfast bar

Other: Test resistant starch type 4

Interventions

Control digestible carbohydrate OTHER

Single serving of control product

Control digestible carbohydrate

Test resistant starch type 4 OTHER

Single serving of test product

Test resistant starch type 4

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cargill: lead
• Biofortis Clinical Research, Inc.: collaborator

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

Related Publications (1)

• Mah E, Garcia-Campayo V, Liska D. Substitution of Corn Starch with Resistant Starch Type 4 in a Breakfast Bar Decreases Postprandial Glucose and Insulin Responses: A Randomized, Controlled, Crossover Study. Curr Dev Nutr. 2018 Aug 9;2(10):nzy066. doi: 10.1093/cdn/nzy066. eCollection 2018 Oct.

  PMID: 30338311 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kathleen M Kelley, MD

  Biofortis Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 4, 2017
• Study Start: June 22, 2017
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

US (1)