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CompletedNCT05723497Updated Feb 10, 2023

Elderberries and Obesity

An interventional study of Elderberry juice and Placebo beverage in Fuel Management, sponsored by Washington State University. Completed at 1 site in United States. Open to participants aged 22 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Washington State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
22 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Fuel Management

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 10 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Washington State University is the lead sponsor of 82 studies on the registry; 16 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Elderberry juice

    Participants will consume elderberry juice twice/day for 1-week.

    Other: Elderberry juice

  • Placebo comparator
    Placebo beverage

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

    Other: Placebo beverage

Interventions

  • OtherElderberry juice

    Participants will consume elderberry juice 1-week.

  • OtherPlacebo beverage

    Participants will consume placebo for 1-week.

06

What researchers measure

Primary outcomes

  1. Substrate oxidation

    Participants will be monitored by a metabolic cart at rest and while walking

    Time frame: 3.5 hours

  2. Glucose tolerance/insulin sensitivity

    Blood will be collected following a meal tolerance test

    Time frame: 3 hours

07

Study locations

1 site
  • Nutrition and Exercise Physiology
    Spokane, Washington 99202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05723497
Lead sponsor
Washington State University
Responsible party
Patrick Solverson (Assistant Professor, Washington State University) — Principal investigator
First posted
Feb 10, 2023
Start date
Jul 27, 2021
Primary completion
Sep 2, 2022
Completion
Sep 2, 2022
Last update
Feb 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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