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Completed

NCT Number: NCT06626373

Elderberry Consumption and Human Health

The objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. To accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. Major study endpoints included blood glucose and insulin response to a high-carbohydrate meal challenge, indirect calorimetry, and profiling of the fecal microbiome.

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Key information

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington State University

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

  • Pregnant or trying to become pregnant
  • Have a body mass index less than 25 kg/m2
  • Are younger than 22 years of age, or older than 75 years of age
  • 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 (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 beverage twice/day 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

  3. Gut Microbiome analysis

    Time frame: 5 minutes

    Feces will be collected before and after the intervention

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Official study title

Elderberry Consumption and Human Health: a Preliminary Investigation Into Effects on Indirect Calorimetry, Insulin Sensitivity, and Microbiome

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

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.

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