Skip to main content
OpenTrials
Completed

NCT Number: NCT05723497

Elderberries and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Exercise Physiology

Spokane, Washington, 99202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elderberry juice

Other

Participants will consume elderberry juice 1-week.

Placebo beverage

Other

Participants will consume placebo for 1-week.

Primary outcomes

  1. Substrate oxidation

    Time frame: 3.5 hours

    Participants will be monitored by a metabolic cart at rest and while walking

  2. Glucose tolerance/insulin sensitivity

    Time frame: 3 hours

    Blood will be collected following a meal tolerance test

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2023
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.