Fuel ManagementNCT05723497
Elderberries and Obesity
A study testing Elderberry juice in people with Fuel Management, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fuel Management
- What is being tested?
- Elderberry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2021to 2 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutrition and Exercise Physiology
Spokane, Washington, 99202
About this study
Official title: Supporting Local Agriculture Via Clinical Research: Human Studies With Elderberries to Improve Biomarkers of Obesity
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.
- Conditions
- Fuel Management
- Being tested
- Elderberry juice, Placebo beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elderberry juiceOther
Participants will consume elderberry juice 1-week.
Placebo beverageOther
Participants will consume placebo for 1-week.
| Study group | Role | What they receive |
|---|---|---|
| Elderberry juice | Experimental | Participants will consume elderberry juice twice/day for 1-week. Receives: Other: Elderberry juice |
| Placebo beverage | Placebo comparator | Participants will consume placebo beverage twice/day for 1-week. Receives: Other: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substrate oxidation
Participants will be monitored by a metabolic cart at rest and while walking
Measured: 3.5 hours
Glucose tolerance/insulin sensitivity
Blood will be collected following a meal tolerance test
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start27 Jul 2021
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuel ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Solverson, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723497
- Sponsor's protocol ID
- 18682
- Status last verified
- Feb 2023
- First submitted
- 20 Jul 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Local Agriculture Via Clinical Research: Human Studies With Elderberries to Improve Biomarkers of Obesity
- ClinicalTrials.gov ID
- NCT05723497
- Acronym / sponsor ID
- 18682
- Conditions
- Fuel Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderberry juice | Experimental | Other: Elderberry juiceParticipants will consume elderberry juice twice/day for 1-week. |
| Placebo beverage | Placebo comparator | Other: Placebo beverageParticipants will consume placebo beverage twice/day for 1-week. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elderberry juiceParticipants will consume elderberry juice 1-week. | Other | Elderberry juice |
| Placebo beverageParticipants will consume placebo for 1-week. | Other | Placebo beverage |
Primary outcome
Substrate oxidation
Time frame: 3.5 hours
Participants will be monitored by a metabolic cart at rest and while walking
Glucose tolerance/insulin sensitivity
Time frame: 3 hours
Blood will be collected following a meal tolerance test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Fuel Management
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elderberry juice in people with Fuel Management, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substrate oxidation (time frame: 3.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.