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Elderberries and Obesity

Sponsor
Washington State University (Other)
Overall Status
Completed
CT.gov ID
NCT05723497
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
13.2
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Elderberry juice
  • Other: Placebo beverage
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Supporting Local Agriculture Via Clinical Research: Human Studies With Elderberries to Improve Biomarkers of Obesity
Actual Study Start Date :
Jul 27, 2021
Actual Primary Completion Date :
Sep 2, 2022
Actual Study Completion Date :
Sep 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Elderberry juice

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

Other: Elderberry juice
Participants will consume elderberry juice 1-week.
Placebo Comparator: Placebo beverage

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

Other: Placebo beverage
Participants will consume placebo for 1-week.

Outcome Measures

Primary Outcome Measures

  1. Substrate oxidation [3.5 hours]

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

  2. Glucose tolerance/insulin sensitivity [3 hours]

    Blood will be collected following a meal tolerance test

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 75 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nutrition and Exercise Physiology Spokane Washington United States 99202

Sponsors and Collaborators

  • Washington State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patrick Solverson, Assistant Professor, Washington State University
ClinicalTrials.gov Identifier:
NCT05723497
Other Study ID Numbers:
  • 18682
First Posted:
Feb 10, 2023
Last Update Posted:
Feb 10, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity

Study Results

No Results Posted as of Feb 10, 2023