Effect of Orange Pomace Fiber on Glycemic Response

NCT02962375 | Completed

• 1 other identifier: IRB2016-118
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Primary object is to determine if 100% orange juice with enzyme-treated orange pomace fiber compared to a 100% orange juice will reduce 2 hr glycemic response as measured by glucose area under the curve. Secondary object is to assess if 100% orange juice with enzyme-treated orange pomace fiber compared to a 100% orange juice will reduce 2 hr insulin iAUC response.

Conditions

Healthy

Keywords

orange pomace fiber; glycemic response

Outcome Measures

Primary Outcomes (1)

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

  plasma glucose concentration as measured by iAUC over a 2 hour

  2 hours

Secondary Outcomes (1)

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

  2 hours

Study Arms (2)

Active Treatment

EXPERIMENTAL

100% orange juice with orange pomace fiber

Dietary Supplement: Active

Control Treatment

PLACEBO COMPARATOR

100% orange juice

Dietary Supplement: Control

Interventions

Active DIETARY_SUPPLEMENT

100% orange juice with orange pomace fiber

Active Treatment

Control DIETARY_SUPPLEMENT

100% orange juice

Control Treatment

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 consumption of study beverage, 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 and avoid vigorous physical activity for 24 h prior to and during study visits. Vigorous physical activity is defined as an activity requiring a large amount of effort, causing rapid breathing and a substantial increase in heart rate (e.g., running, fast cycling, and fast swimming).
• 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 glucose ≥100 mg/dL.
• Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening visit.
• Subject has had major trauma or a surgical event within 2 months of the study.
• Subject has had a weight change ≥4.5 kg within 2 months of visit.
• 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 is a vegan or a vegetarian.
• 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.
• 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.
• Subject has participated in any clinical trial within 30d prior to enrollment.

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

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: November 9, 2016
• First Posted: November 11, 2016
• Study Start: November 22, 2016
• Primary Completion: February 14, 2017
• Study Completion: September 18, 2017
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)