Elderberry Consumption and Human Health

NCT06626373 | Completed

• 1 other identifier: 18597
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Unspecified

Keywords

Obesity; Elderberry

Outcome Measures

Primary Outcomes (3)

• 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

• Gut Microbiome analysis

  Feces will be collected before and after the intervention

  5 minutes

Study Arms (2)

Experimental: Elderberry Juice

EXPERIMENTAL

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

Other: Elderberry Juice

Placebo Comparator: Placebo beverage

PLACEBO COMPARATOR

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

Other: Placebo Beverage

Interventions

Elderberry Juice OTHER

Participants will consume elderberry juice 1-week.

Experimental: Elderberry Juice

Placebo Beverage OTHER

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

Placebo Comparator: Placebo beverage

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Washington State University: lead

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

Related Publications (2)

• 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.

  PMID: 38776153 BACKGROUND

• 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.

  PMID: 37432227 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double (ParticipantOutcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: February 27, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)