Effects of Beverages Containing Orange or Apple Pomace on Digestive Health in Adults

PepsiCo

Status: Completed

Conditions: Digestive Health

Treatments: Other: Apple Juice; Other: Apple Juice and Apple Pomace; Other: Orange Juice; Other: Orange juice + Orange Pomace

Study type: Interventional

Funder types: Industry

Identifiers

NCT03749031

PEP-1805

Details and patient eligibility

About

This is a randomized crossover intervention designed to evaluate effects of daily intake of beverages containing orange or apple Pomace on gastrointestinal function as measured by stool frequency. Additional outcomes will include aspects of digestive health and self-reported GI symptoms and dietary intake as well as analysis of gut microbiota.

Enrollment: 90 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females 18-60 years old
• Willing and able to consume 16 oz. of orange or apple beverage per day for 4 week periods
• Willing to maintain usual diet, smoking status, physical activity pattern, supplements and meds

Exclusion criteria

• Food allergies or sensitivities to ingredients in study beverages
• Presence or history of GI condition, endocrine (including diabetes), cardiovascular disease or other disease or condition that could interfere in the interpretation of the study results in the opinion of the Investigator.
• Extreme dietary habits including vegetarian, vegan or Atkins diet
• Females or are pregnant, planning to become pregnant or breast feeding during the study period.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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90 participants in 4 patient groups, including a placebo group

Orange juice only

Placebo Comparator group

Description:

16 oz. orange juice per day for 4 weeks

Treatment:

Other: Orange Juice

orange juice + orange Pomace

Experimental group

Description:

16 oz. orange juice + orange Pomace per day for 4 weeks

Treatment:

Other: Orange juice + Orange Pomace

Apple juice only

Placebo Comparator group

Description:

16 oz. apple juice per day for 4 weeks

Treatment:

Other: Apple Juice

Apple Juice + Apple Pomace

Experimental group

Description:

16 oz. apple juice + apple Pomace per day for 4 weeks

Treatment:

Other: Apple Juice and Apple Pomace