Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131, United States
NCT Number: NCT05817383
This study aims to investigate the impact of daily freeze-dried blueberry powder consumption on the gut microbiota, fecal short chain fatty acids, and depressive symptom severity in 40older, sedentary adults with depressive symptoms.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Roslindale, Massachusetts, 02131, United States
This study is an ancillary project to a currently funded randomized, placebo-controlled 12-week intervention in older, sedentary adults with depressive symptoms (IRB# Pro00064749). This specific project proposes distinct aims to the trial by gathering preliminary data on the synergistic impact of dietary fiber and anthocyanins (via freeze-dried blueberry powder) on the gut-microbiota, gut-derived metabolites, and depressive symptoms in older adults.
Participants will then be randomized to consume either 48 g of freeze-dried blueberry powder (~600 mg of anthocyanins and ~8 g of fiber) or 48 g of a nutritionally matched placebo powder (devoid of anthocyanins and fiber) each day for a total of 12 weeks.
At baseline, participants will be undergo assessments for depressive symptom severity and provide a fecal sample for gut microbiota and short chain fatty acid measurement. After 4, 8, and 12 weeks of consuming the powder there will be study visits that assess depressive symptom severity. Additionally, a final fecal sample will be taken after 12 weeks of the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be asked to consume 48 grams of freeze-dried blueberry powder (~ equivalent to 2 cups of fresh blueberries) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.
Participants will be asked to consume 48 grams of a nutritionally matched placebo powder (that does not contain fiber or anthocyanins) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.
Time frame: Change between baseline and 12 weeks
Severity of depressive symptoms will be measured before and after the intervention with the Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scores range from 0 to 60 points, with higher scores indicating more sever depressive symptoms.
Time frame: Change between baseline and 12 week follow-up
The abundance of the top 20 most prevalent microbes in our that produce short chain fatty acids (e.g., Bifidobacteria, Eubacterium, and Clostridium) will be evaluated by whole genome sequencing
Time frame: Percent change between baseline and 12 week follow-up
The relative abundance of short chain fatty acids (i.e., butyrate ) in feces will be measured using liquid chromatography mass spectrometry.
Hebrew SeniorLife
Other
Blueberries, Gut Microbiota, and Metabolites in Depressed Older Adults - A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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