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Elderberries and Obesity

Primary Purpose

Fuel Management

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elderberry juice
Placebo beverage
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fuel Management

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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: 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

Sites / Locations

  • Nutrition and Exercise Physiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Elderberry juice

Placebo beverage

Arm Description

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

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

Outcomes

Primary Outcome Measures

Substrate oxidation
Participants will be monitored by a metabolic cart at rest and while walking
Glucose tolerance/insulin sensitivity
Blood will be collected following a meal tolerance test

Secondary Outcome Measures

Full Information

First Posted
July 20, 2021
Last Updated
February 8, 2023
Sponsor
Washington State University
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1. Study Identification

Unique Protocol Identification Number
NCT05723497
Brief Title
Elderberries and Obesity
Official Title
Supporting Local Agriculture Via Clinical Research: Human Studies With Elderberries to Improve Biomarkers of Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuel Management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elderberry juice
Arm Type
Experimental
Arm Description
Participants will consume elderberry juice twice/day for 1-week.
Arm Title
Placebo beverage
Arm Type
Placebo Comparator
Arm Description
Participants will consume placebo beverage twice/day for 1-week.
Intervention Type
Other
Intervention Name(s)
Elderberry juice
Intervention Description
Participants will consume elderberry juice 1-week.
Intervention Type
Other
Intervention Name(s)
Placebo beverage
Intervention Description
Participants will consume placebo for 1-week.
Primary Outcome Measure Information:
Title
Substrate oxidation
Description
Participants will be monitored by a metabolic cart at rest and while walking
Time Frame
3.5 hours
Title
Glucose tolerance/insulin sensitivity
Description
Blood will be collected following a meal tolerance test
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Nutrition and Exercise Physiology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Elderberries and Obesity

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