Postprandial Glycemia in Orange Products

Launched by CLINICAL NUTRITION RESEARCH CENTER, ILLINOIS INSTITUTE OF TECHNOLOGY · Sep 24, 2018

Keywords

ClinConnect Summary

This study is a randomized, 3-arm, within subject cross-over trial allowing for three acute evaluations of 100% orange juice (250 g), 100% Orange Juice with enzyme-treated orange pomace fiber (157 g orange juice with 100 g orange pomace), and raw orange (227 g edible portion of navel orange) on glucose and insulin response in fifty-two healthy men and women aged 20-45 years.

A planned sample size of 52 will be enrolled into the study. This study will require one initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per subject to complete.

The initial sc...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • 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
• Exclusion Criteria:
• • •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.
• • No participation in another Sponsored protocol within 6 months prior to enrollment