Postprandial Glycemia in Orange Products

NCT03685201 | Completed

• 1 other identifier: IRB2018-083
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to compare the effects of a whole orange, orange juice alone, and orange juice with pomace on 2 hr glycemic response as measured by maximal glucose concentration.

Conditions

Healthy

Keywords

orange pomace fiber; glycemic response; Orange

Outcome Measures

Primary Outcomes (1)

• Plasma Glucose maximal concentration (Cmax) over 2 hours

  Plasma Glucose maximal concentration (Cmax) over 2 hours

  Postprandial 2 hours

Secondary Outcomes (1)

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

  Postprandial 2 hours

Other Outcomes (8)

• Time to plasma glucose maximal concentration (Tmax) over 2 hours

  Postprandial 2 hours

• Plasma Insulin Cmax over 2 hours

  Postprandial 2 hours

• 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

  Postprandial 2 hours

Study Arms (3)

Orange Juice1

ACTIVE COMPARATOR

100% orange juice

Dietary Supplement: Orange Juice1

Orange Juice2

EXPERIMENTAL

100% Orange Juice with enzyme-treated orange pomace fiber

Dietary Supplement: Orange Juice2

Raw Orange

PLACEBO COMPARATOR

raw orange

Dietary Supplement: Raw Orange

Interventions

Orange Juice1 DIETARY_SUPPLEMENT

100% Orange Juice

Orange Juice1

Orange Juice2 DIETARY_SUPPLEMENT

100% Orange Juice with enzyme-treated orange pomace fiber

Orange Juice2

Raw Orange DIETARY_SUPPLEMENT

Raw Orange

Raw Orange

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 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 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 stable dose of current vitamins, minerals, supplements and medications not interfering with study outcomes, including birth control, throughout 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 (ie. 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.
• 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.
• 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

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: September 20, 2018
• First Posted: September 26, 2018
• Study Start: September 13, 2018
• Primary Completion: November 24, 2019
• Study Completion: November 24, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)