Elderberries and Obesity

Study Overview
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Brief Summary
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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.

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

Conditions
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Fuel Management

Intervention / Treatment
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* Other: Elderberry juice
* Other: Placebo beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderberry juice<br>Participants will consume elderberry juice twice/day for 1-week. | Other: Elderberry juice<br>* Participants will consume elderberry juice 1-week.<br>|
| Placebo Comparator: Placebo beverage<br>Participants will consume placebo beverage twice/day for 1-week. | Other: Placebo beverage<br>* Participants will consume placebo for 1-week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substrate oxidation | Participants will be monitored by a metabolic cart at rest and while walking | 3.5 hours | 
| Glucose tolerance/insulin sensitivity | Blood will be collected following a meal tolerance test | 3 hours |