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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Honey sweetened yogurt | Experimental | 1 tbsp. of honey in 0.6 cup (150g) of plain yogurt. The participants will be asked to consume 2 morning servings of the yogurt for a total of 2 tbsp. of the assigned honey per day. |
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| Sugar sweetened yogurt | Placebo Comparator | Sugar will be added to 0.6 cup (150g) of plain yogurt in an isocaloric amount compared to the honey. The participants will be asked to consume 2 morning servings of the yogurt per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honey sweetened yogurt | Other | 2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions |
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| Measure | Description | Time Frame |
|---|---|---|
| Concentration of CD4+ T Helper (TH)17 cytokines | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Secondary bile acids | plasma microbial metabolites | 4 weeks |
| Concentration of Short chain fatty acids | Fecal microbial metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert R Holt, PhD | Contact | 530-752-4950 | rrholt@ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carl L Keen, PhD | University of California, Davis; Department of Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis; Department of Nutrition | Recruiting | Davis | California | 95616 | United States |
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| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2019 | Nov 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Randomized single-blind 2-arm crossover trial. Each arm will be 4 weeks in length, with a 4 week washout between arms.
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The honey intervention or isocaloric amounts of sugar will be provided in yogurt. The study participant will not be told what sweetener they will be receiving.
| Sugar sweetened yogurt | Other | sugar added, in an isocaloric fashion to the honey, to 1.2 cups of yogurt per day, split into two equal portions |
|
| 4 weeks |
| Concentration of urolithins and other ellagitannin-derived metabolites | microbial metabolites | 4 weeks |
| Concentration of soluble NADPH oxidase (NOX2) | plasma marker oxidative stress | 4 weeks |
| Concentration of uric acid | plasma marker oxidative stress | 4 weeks |
| Concentration of total Nitrate/Nitrite and Nitric Oxide related metabolites (RSNO) | dietary nitrate and NO metabolites | 4 weeks |
| Concentration of untargeted metabolomics | metabolism | 4 weeks |
| Determination of microbial populations | stool bacterial population | 4 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |