Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults

NCT04312022 | Completed Results

• 1 other identifier: 0436-18-FB
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the impacts of a combined berry extract supplement (hawthorn berry, tart cherry, and bromelain extracts) on total antioxidant capacity, endothelial function, blood pressure, oxygen utility capacity, and fatigue index in healthy young adults.

Conditions

Healthy

Keywords

anthocyanin; endothelial function; oxygen; vascular function; blood pressure; antioxidant

Outcome Measures

Primary Outcomes (1)

• Endothelial Function

  Endothelial function was measured using flow-mediated dilation in percents (%). A higher value represents a better outcome. Scale range for endothelial function is approximately 8-12% for healthy populations.

  1 day

Secondary Outcomes (8)

• Systolic Blood Pressure

  1 day

• Diastolic Blood Pressure

  1 day

• Oxygen Utility Capacity (Tissue Saturation Index)

  1 day

• Exercise Fatigue Index During Leg Extension

  1 day

• Exercise Fatigue Index During Leg Flexion

  1 day

Study Arms (2)

Berry extract intake, then Placebo

EXPERIMENTAL

Participants received a single dose of berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain). After a washout period of 2 weeks, they then received a single dose of the placebo (flour capsule).

Dietary Supplement: Berry extract

Placebo intake, then Berry extract intake

PLACEBO COMPARATOR

Participants received a single dose of placebo (flour capsule). After a washout period of 2 weeks, they then received a single dose of berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain).

Other: Placebo

Interventions

Berry extract DIETARY_SUPPLEMENT

Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)

Berry extract intake, then Placebo

Placebo OTHER

Placebo (flour capsule)

Placebo intake, then Berry extract intake

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• otherwise healthy adult

You may not qualify if:

• cardiovascular disease
• neurological disorder
• metabolic disorder
• respiratory disorder
• renal diseases
• musculoskeletal injury
• bleeding disorder
• allergy to fruit
• pregnant/breast feeding
• taking daily medication (prescription or over-the-counter)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Song-Young Park
• Organization: University of Nebraska at Omaha

song-youngpark@unomaha.edu

402-554-3374

Study Officials

• Song-Young Park, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the subject nor the investigators were aware of the study assignments, which were assigned by a lab member not directly involved in the measurements of the research.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, crossover design (1:1)

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: November 4, 2018
• Primary Completion: March 29, 2019
• Study Completion: June 13, 2019
• Last Updated: February 6, 2024
• Results First Posted: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)