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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05723497
Other study ID # 18682
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2021
Est. completion date September 2, 2022

Study information

Verified date February 2023
Source Washington State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2, 2022
Est. primary completion date September 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Elderberry juice
Participants will consume elderberry juice 1-week.
Placebo beverage
Participants will consume placebo for 1-week.

Locations

Country Name City State
United States Nutrition and Exercise Physiology Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Substrate oxidation Participants will be monitored by a metabolic cart at rest and while walking 3.5 hours
Primary Glucose tolerance/insulin sensitivity Blood will be collected following a meal tolerance test 3 hours
See also
  Status Clinical Trial Phase
Completed NCT01932879 - Blackberry Polyphenol Intake and Fuel Management N/A