Elderberry Consumption and Human Health

Washington State University

Status: Completed

Conditions: Obesity, Unspecified

Treatments: Other: Elderberry Juice; Other: Placebo Beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT06626373

18597

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

Experimental: Elderberry Juice

Experimental group

Description:

Participants will consume elderberry juice twice/day for 1-week as well as our provided diet for 4 days.

Treatment:

Other: Elderberry Juice

Placebo Comparator: Placebo beverage

Placebo Comparator group

Description:

Participants will consume placebo beverage twice/day for 1-week as well as our provided diet for 4 days.

Treatment:

Other: Placebo Beverage