Elderberries and Obesity

Supporting Local Agriculture Via Clinical Research: Human Studies With Elderberries to Improve Biomarkers of Obesity

Previous studies in humans indicate that anthocyanin-rich berries can positively alter fat oxidation and insulin sensitivity. This study will determine if this is also true with elderberries, which are a more concentrated source of anthocyanins compared to other commonly consumed berries.

Study Overview

• Status: Completed
• Conditions: Fuel Management
• Intervention / Treatment: Other: Elderberry juice; Other: Placebo beverage

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Nutrition and Exercise Physiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above.

Exclusion Criteria:

• Are not fully vaccinated against COVID-19 (at least 2-weeks out from final dose at time of staff meeting)
• Have a body mass index less than 25 kg/m2
• Are younger than 22 years of age, or older than 75 years of age
• Pregnant, lactating, or intending to become pregnant during the study period, or have given birth in the past year
• Known allergy or intolerance to elderberries
• History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring a special diet that is not in accord with the diet behavior requested for this study
• Adherence to restrictive (vegetarian or vegan) or extreme (fad [ex. Ketogenic or Atkins] or quick weight loss/gain) diet patterns and unwillingness to consume a conventional, omnivorous diet and maintain body weight
• Habitual use of tobacco or marijuana (including vaping) products in the last 6 months
• Diagnosis or treatment of cancer in the past 3 years
• Crohn's disease or diverticulitis
• Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
• Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
• Type 2 diabetes requiring the use of medication
• Fasting blood glucose > 125 mg/dL
• Unable or unwilling to give informed consent or communicate with study staff
• Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Elderberry juice; Participants will consume elderberry juice twice/day for 1-week.	Other: Elderberry juice; Participants will consume elderberry juice 1-week.
PLACEBO_COMPARATOR: Placebo beverage; Participants will consume placebo beverage twice/day for 1-week.	Other: Placebo beverage; Participants will consume placebo for 1-week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substrate oxidation	Participants will be monitored by a metabolic cart at rest and while walking	3.5 hours
Glucose tolerance/insulin sensitivity	Blood will be collected following a meal tolerance test	3 hours

Collaborators and Investigators

• Sponsor: Washington State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2021
• Primary Completion (ACTUAL): September 2, 2022
• Study Completion (ACTUAL): September 2, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 18682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No