Elderberries and Obesity

Not Applicable

Completed

• Conditions: Fuel Management
• Interventions: Other: Elderberry juice; Other: Placebo beverage

• Registration Number: NCT05723497
• Lead Sponsor: Washington State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-20
• Study Start: 2021-07-27
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-10
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Elderberry juice	Elderberry juice	Participants will consume elderberry juice twice/day for 1-week.
Placebo beverage	Placebo beverage	Participants will consume placebo beverage twice/day for 1-week.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nutrition and Exercise Physiology; 🇺🇸 Spokane, Washington, United States