Food Containing Resistant Starch Type 4 and Postprandial Glycemic Response

NCT03844503 | Completed

• 1 other identifier: IRB2019-005
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to determine if resistant starch reduces the 2 hour glycemic response as measured by positive incremental area under the blood glucose response curve (Positive iAUC- ignores area below fasting). Secondary endpoints include insulin iAUC, glucose and insulin net incremental AUC (net iAUC), time point of peak rise (T max) of glucose and insulin, and glucose and insulin concentrations at each time point (C max).

Conditions

Healthy

Keywords

Cereal bar; Fiber; Resistant Starch; Glycemic Response; Insulin Response

Outcome Measures

Primary Outcomes (1)

• Changes in Plasma Glucose concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours

  Changes in plasma glucose concentration as measured by positive iAUC (ignoring area below fasting) over a 2 hour Postprandial Test day after administration of active treatment compared to control treatment

  Postprandial 2 hours

Secondary Outcomes (6)

• Changes in plasma insulin concentration as measured by iAUC over a 2 hour Postprandial Test day after administration of active treatments compared to control treatment

  Postprandial 2 hours

• Changes in Plasma Insulin concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours

  Postprandial 2 hours

• Plasma Glucose maximal concentration (Cmax) over 2 hours

  Postprandial 2 hours

• Plasma Insulin maximal concentration (Cmax) over 2 hours

  Postprandial 2 hours

• Change in postprandial blood glucose concentration responses for treatments compared to control over 2-hour postprandial period

  Postprandial 2 hours

Study Arms (3)

Cereal Bar no fiber

PLACEBO COMPARATOR

Cereal bar without fiber

Dietary Supplement: Cereal Bar no fiber

Cereal bar with 10 g fiber

ACTIVE COMPARATOR

Cereal bar with 10 g fiber

Dietary Supplement: Cereal bar with 10 g fiber

Cereal bar with 20 g fiber

ACTIVE COMPARATOR

Cereal bar with 20 g fiber

Dietary Supplement: Cereal bar with 20 g fiber

Interventions

Cereal Bar no fiber DIETARY_SUPPLEMENT

Cereal Bar no fiber

Cereal Bar no fiber

Cereal bar with 10 g fiber DIETARY_SUPPLEMENT

Cereal bar with 10 g fiber

Cereal bar with 10 g fiber

Cereal bar with 20 g fiber DIETARY_SUPPLEMENT

Cereal bar with 20 g fiber

Cereal bar with 20 g fiber

Eligibility Criteria

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

You may qualify if:

• Subject is a male or female, 20-45 years of age, inclusive.
• Subject has a BMI of 20.0-24.9 kg/m2, inclusive and weight ≥ 110 lb. at screening visit.
• Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
• Subject is willing to follow study instructions including compliance with dietary restrictions, consumption of study bars, and study visit schedule.
• Subject is judged to be in good health on the basis of the medical history.
• Subject is willing to abstain from alcohol consumption for 24 hours prior to study visit.
• Exercise to be maintained throughout study duration, including 3 days before study visit
• Subject is willing to maintain a stable dose of current vitamins, minerals, supplements and medications not interfering with study outcomes, including birth control, throughout the study duration.
• Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator/s and is willing to complete study procedures.

You may not qualify if:

• Subject has fasting finger prick glucose \>100 mg/dL.
• Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
• Subject has had major trauma or a surgical event within 2 months of study visit 1.
• Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (i.e. liposuction, laser fat removal, etc)
• Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
• Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Subject has a history of extreme dietary habits, as judged by the Investigator (e.g., Atkins diet, etc.).
• Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• Subject has a known intolerance or sensitivity to any ingredients in the study products.
• Subject has used medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids 2 weeks prior to visit 1 and throughout the study.
• Subjects who used fiber supplements.
• Subject taking systemic steroids, extreme alcohol use, or drug user.
• Subject has vein access score less than 7.
• Subject is a female, who is pregnant, planning to be pregnant during the study period or lactating.
• Subject is a current smoker. Past smoker abstinence for less than 2 years.

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 18, 2019
• Study Start: February 11, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)