Clinical trial NCT04248127: The Influence of Honey-flavored Yogurt on Low-grade Inflammation and Gut Health in Middle to Older Aged Women.
Official title: The Influence of Honey-flavored Yogurt on Low-grade Inflammation and Gut Health in Middle to Older Aged Women.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight
Keywords: Phenolic
Honey
Inflammation
Yogurt
Microbiome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized single-blind 2-arm crossover trial. Each arm will be 4 weeks in length, with a 4 week washout between arms.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal female: 45-65 years
* Women: lack of menses for at least two years.
* Subject is willing and able to comply with the study protocols.
* Subject is willing to participate in all study procedures
* BMI 25.0 - 30.0 kg/m2

Exclusion Criteria:

* BMI ≥ 31 kg/m2
* Food allergies
* Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
* Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
* Use of concentrated food supplements/powders and extracts
* Fruit consumption \> 2 cups/day
* Vegetable consumption \>3 cups/day
* Self-reported restriction of physical activity due to a chronic health condition
* Self-reported chronic/routine high intensity exercise
* Self-reported diabetes
* Blood pressure ≥ 140/90 mm Hg
* Self-reported renal or liver disease
* Self-reported heart disease, which includes cardiovascular events and stroke
* Abnormal Metabolic or CBC panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
* Self-reported cancer within past 5 years
* Self-reported malabsorption
* Currently taking prescription drugs or supplements.
* Supplement use other than a general formula of vitamins and minerals that meet the RDA
* Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
* Indications of substance or alcohol abuse within the last 3 years
* Cannabis use
* Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative \< 55 years; CHD in female first degree relative \< 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL\]. (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp)
* Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol \[i.e. family history of premature coronary artery disease (male first degree relative \< 55 years; CHD in female first degree relative \< 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL\]. (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp);
* Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol \[i.e. family history of premature coronary artery disease (male first degree relative \< 55 years; CHD in female first degree relative \< 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL\], and a Framingham 10-year Risk Score 10-20% (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp).
* Current enrollee in a clinical research study.

Primary outcomes:
measure: Concentration of CD4+ T Helper (TH)17 cytokines
timeFrame: 4 weeks
Secondary outcomes:
measure: Concentration of Secondary bile acids
timeFrame: 4 weeks
measure: Concentration of Short chain fatty acids
timeFrame: 4 weeks
measure: Concentration of urolithins and other ellagitannin-derived metabolites
timeFrame: 4 weeks
measure: Concentration of soluble NADPH oxidase (NOX2)
timeFrame: 4 weeks
measure: Concentration of uric acid
timeFrame: 4 weeks
measure: Concentration of total Nitrate/Nitrite and Nitric Oxide related metabolites (RSNO)
timeFrame: 4 weeks
measure: Concentration of untargeted metabolomics
timeFrame: 4 weeks
measure: Determination of microbial populations
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis; Department of Nutrition
state: California
Study officials:
affiliation: University of California, Davis; Department of Nutrition
name: Carl L Keen, PhD
role: PRINCIPAL_INVESTIGATOR
References: