Obesity, UnspecifiedNCT06626373
Elderberry Consumption and Human Health
A study testing Elderberry Juice in people with Obesity, Unspecified, run by Washington State University at 1 site in United States.
Trial summary
The objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. To accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Unspecified
- What is being tested?
- Elderberry Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 10 May 2024
- 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
- Pregnant or trying to become pregnant
- Have a body mass index less than 25 kg/m2
- Are younger than 22 years of age, or older than 75 years of age
- 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
Show all 16Show fewer
- Habitual use of tobacco (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
Washington State University
Spokane, Washington, 99202
About this study
Official title: Elderberry Consumption and Human Health: a Preliminary Investigation Into Effects on Indirect Calorimetry, Insulin Sensitivity, and Microbiome
The objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. To accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. Major study endpoints included blood glucose and insulin response to a high-carbohydrate meal challenge, indirect calorimetry, and profiling of the fecal microbiome.
- Conditions
- Obesity, Unspecified
- Being tested
- Elderberry Juice, Placebo Beverage
- Keywords
- Obesity, Elderberry
- Medical subject headings
- Obesity
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 beverage twice/day for 1-week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Elderberry Juice | Experimental | Participants will consume elderberry juice twice/day for 1-week as well as our provided diet for 4 days. Receives: Other: Elderberry Juice |
| Placebo Comparator: Placebo beverage | Placebo comparator | Participants will consume placebo beverage twice/day for 1-week as well as our provided diet for 4 days. 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
Gut Microbiome analysis
Feces will be collected before and after the intervention
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start27 Feb 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, UnspecifiedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626373
- Sponsor's protocol ID
- 18597
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minj J, Riordan J, Teets C, Fernholz-Hartman H, Tanggono A, Lee Y, Chauvin T, Carbonero F, Solverson P. Diet-Induced Rodent Obesity Is Prevented and the Fecal Microbiome Is Improved with Elderberry (Sambucus nigra ssp. canadensis) Juice Powder. J Agric Food Chem. 2024 Jun 5;72(22):12555-12565. doi: 10.1021/acs.jafc.4c01211. Epub 2024 May 22.
PubMed 38776153Rust BM, Riordan JO, Carbonero FG, Solverson PM. One-Week Elderberry Juice Treatment Increases Carbohydrate Oxidation after a Meal Tolerance Test and Is Well Tolerated in Adults: A Randomized Controlled Pilot Study. Nutrients. 2023 Apr 25;15(9):2072. doi: 10.3390/nu15092072.
PubMed 37432227
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderberry Consumption and Human Health: a Preliminary Investigation Into Effects on Indirect Calorimetry, Insulin Sensitivity, and Microbiome
- ClinicalTrials.gov ID
- NCT06626373
- Acronym / sponsor ID
- 18597
- Conditions
- Obesity, Unspecified
- Keywords
- Obesity, Elderberry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 3 Oct 2024 (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.
The objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. To accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. Major study endpoints included blood glucose and insulin response to a high-carbohydrate meal challenge, indirect calorimetry, and profiling of the fecal microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Elderberry Juice | Experimental | Other: Elderberry JuiceParticipants will consume elderberry juice twice/day for 1-week as well as our provided diet for 4 days. |
| Placebo Comparator: Placebo beverage | Placebo comparator | Other: Placebo BeverageParticipants will consume placebo beverage twice/day for 1-week as well as our provided diet for 4 days. |
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 (16 listed)
- Pregnant or trying to become pregnant
- Have a body mass index less than 25 kg/m2
- Are younger than 22 years of age, or older than 75 years of age
- 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
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 | Experimental: Elderberry Juice |
| Placebo BeverageParticipants will consume placebo beverage twice/day for 1-week. | Other | Placebo Comparator: 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
Gut Microbiome analysis
Time frame: 5 minutes
Feces will be collected before and after the intervention
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 3 Oct 2024.
- Background: PubMed 38776153Minj J, Riordan J, Teets C, Fernholz-Hartman H, Tanggono A, Lee Y, Chauvin T, Carbonero F, Solverson P. Diet-Induced Rodent Obesity Is Prevented and the Fecal Microbiome Is Improved with Elderberry (Sambucus nigra ssp. canadensis) Juice Powder. J Agric Food Chem. 2024 Jun 5;72(22):12555-12565. doi: 10.1021/acs.jafc.4c01211. Epub 2024 May 22.
- Background: PubMed 37432227Rust BM, Riordan JO, Carbonero FG, Solverson PM. One-Week Elderberry Juice Treatment Increases Carbohydrate Oxidation after a Meal Tolerance Test and Is Well Tolerated in Adults: A Randomized Controlled Pilot Study. Nutrients. 2023 Apr 25;15(9):2072. doi: 10.3390/nu15092072.
- Individual participant dataSharing planned: No
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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 Obesity, Unspecified, 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 16 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 3 Oct 2024. 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06626373, which also lists 2 linked publications.
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 3 Oct 2024.