NCT06626373|Completed
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Sponsor study identifier
interventional
18
1 country
1
Study Start
February 27, 2023
Actual (reported)Primary Completion
May 10, 2024
Actual (reported)Study Completion
May 10, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 27, 2023
Actual (reported)May 10, 2024
Actual (reported)May 10, 2024
Actual (reported)October 1, 2024
Actual (reported)October 3, 2024
Actual (reported)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
Gut Microbiome analysis
Feces will be collected before and after the intervention
5 minutes
Participants will consume elderberry juice twice/day for 1-week as well as our provided diet for 4 days.
Participants will consume placebo beverage twice/day for 1-week as well as our provided diet for 4 days.
Participants will consume elderberry juice 1-week.
Participants will consume placebo beverage twice/day for 1-week.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Washington State University
Spokane, Washington, 99202, United States
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.
Rust 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.
18 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2024
First Posted
October 3, 2024
Study Start
February 27, 2023
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 10, 2024
Actual (reported)Study Completion
May 10, 2024
Actual (reported)Last Updated
October 3, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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