Elderberry Consumption and Human Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2024-05-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Double (ParticipantOutcomes Assessor)

Study Groups

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Experimental: Elderberry Juice

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

Group Type EXPERIMENTAL

Elderberry Juice

Intervention Type OTHER

Participants will consume elderberry juice 1-week.

Placebo Comparator: Placebo beverage

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

Group Type PLACEBO_COMPARATOR

Placebo Beverage

Intervention Type OTHER

Participants will consume placebo beverage twice/day for 1-week.

Interventions

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Elderberry Juice

Participants will consume elderberry juice 1-week.

Intervention Type OTHER

Placebo Beverage

Participants will consume placebo beverage twice/day for 1-week.

Intervention Type OTHER

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

* 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

Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes