Clinical trial NCT06626373: Elderberry Consumption and Human Health
Official title: Elderberry Consumption and Human Health: a Preliminary Investigation Into Effects on Indirect Calorimetry, Insulin Sensitivity, and Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Unspecified
Keywords: Obesity
Elderberry
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 18
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&gt; 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

Primary outcomes:
measure: Substrate oxidation
timeFrame: 3.5 hours
measure: Glucose tolerance/insulin sensitivity
timeFrame: 3 hours
measure: Gut Microbiome analysis
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
References:
citation: Minj J, Riordan J, Teets C, Fernholz-Hartman H, Tanggono A, Lee Y, Chauvin T, Carbonero F, Solverson P. Diet-Induced Rodent Obesity Is Prevented and the Fecal Microbiome Is Improved with Elderberry (Sambucus nigra ssp. canadensis) Juice Powder. J Agric Food Chem. 2024 Jun 5;72(22):12555-12565. doi: 10.1021/acs.jafc.4c01211. Epub 2024 May 22.
citation: Rust BM, Riordan JO, Carbonero FG, Solverson PM. One-Week Elderberry Juice Treatment Increases Carbohydrate Oxidation after a Meal Tolerance Test and Is Well Tolerated in Adults: A Randomized Controlled Pilot Study. Nutrients. 2023 Apr 25;15(9):2072. doi: 10.3390/nu15092072.