Elderberries and Obesity | NCT05723497

Studies
Elderberries and Obesity

NCT05723497

Sponsor

Washington State University

Status

Completed

Last Update Posted

Feb 10, 2023Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Fuel Management

Interventions

Elderberry juice
Placebo beverage

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2021Actual

Primary Completion Date

Sep 2, 2022Actual

Completion Date

Sep 2, 2022Actual

First Submitted Date

Jul 20, 2021

First Submission Date that Met QC Criteria

Feb 8, 2023

First Posted Date

Feb 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2023

Last Update Posted Date

Feb 10, 2023Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderberry juice	Experimental	Participants will consume elderberry juice twice/day for 1-week.	Other: Elderberry juice
Placebo beverage	Placebo Comparator	Participants will consume placebo beverage twice/day for 1-week.	Other: Placebo beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elderberry juice	Other	Participants will consume elderberry juice 1-week.	Elderberry juice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided