University of California, Davis; Department of Nutrition
Davis, California, 95616, United States
Location status: Recruiting
NCT Number: NCT04248127
A randomized, double-blind, crossover dietary intervention trial will test the effects of 4 weeks of daily honey-flavored yogurt intake on markers of inflammation (Th17 cytokines) and oxidative stress (NOX2, UA, RSNO) and associative changes with microbial derived metabolites (SCFAs, BAs, ellagitannins), metabolism and the fecal microbiome. The above suite of selected markers will capture diet-induced systemic changes in inflammation and oxidative stress, while assessing associated microbial changes.
Interested in participating?
Request Info45 year–65 year
Female
Interventional
Not applicable
Davis, California, 95616, United States
Location status: Recruiting
Those qualified for enrollment will be randomized into a double-blind crossover study to consume 2 morning servings of a 0.6 cup (150g) of plain yogurt with : A) cane sugar added in an isocaloric level as the honey or, B) 1 tbsp of phenolic-rich honey for 4 weeks. A one-month washout between periods will be used. The participants will be instructed to consume one yogurt in replacement of or as part of breakfast, and as a late morning snack. They will also be instructed to not add any additional items to the yogurt. Therefore, each study participant will consume 2 tbsp. of honey a day for four weeks, which is a realistic amount typically consumed by honey users.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions
sugar added, in an isocaloric fashion to the honey, to 1.2 cups of yogurt per day, split into two equal portions
Time frame: 4 weeks
Cytokines included in the panel are: Il-1b, IL-4, IL-6, IL-10, IL-17a, IL-21, IL-22, IL-23, IL-31, IL-33, IFN-gamma, TNF-alpha, IL-17f.
Time frame: 4 weeks
plasma microbial metabolites
Time frame: 4 weeks
Fecal microbial metabolites
Time frame: 4 weeks
microbial metabolites
Time frame: 4 weeks
plasma marker oxidative stress
Time frame: 4 weeks
plasma marker oxidative stress
Time frame: 4 weeks
dietary nitrate and NO metabolites
Time frame: 4 weeks
metabolism
Time frame: 4 weeks
stool bacterial population
Contact information is provided by the study sponsor or research team.
University of California, Davis
Other
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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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