Elderberry Consumption and Human Health

Not Applicable

Completed

• Conditions: Obesity, Unspecified

• Registration Number: NCT06626373
• Lead Sponsor: Washington State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-27
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10
• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Substrate oxidation	3.5 hours	Participants will be monitored by a metabolic cart at rest and while walking
Glucose tolerance/insulin sensitivity	3 hours	Blood will be collected following a meal tolerance test
Gut Microbiome analysis	5 minutes	Feces will be collected before and after the intervention

Trial Locations

Locations (1)

Washington State University; 🇺🇸 Spokane, Washington, United States