The Influence of Honey-flavored Yogurt on Low-grade Inflammation and Gut Health in Middle to Older Aged Women.

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight
• Intervention / Treatment: Other: Honey sweetened yogurt; Other: Sugar sweetened yogurt

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert R Holt, PhD; Phone Number: 530-752-4950; Email: rrholt@ucdavis.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Recruiting
      • University of California, Davis; Department of Nutrition
      • Contact: Roberta Holt, PhD; Phone Number: 530-752-4950; Email: rrholt@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Honey sweetened yogurt; 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.	Other: Honey sweetened yogurt; 2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions
Placebo Comparator: Sugar sweetened yogurt; 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.	Other: Sugar sweetened yogurt; sugar added, in an isocaloric fashion to the honey, to 1.2 cups of yogurt per day, split into two equal portions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Secondary bile acids	plasma microbial metabolites	4 weeks
Concentration of Short chain fatty acids	Fecal microbial metabolites	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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Carl L Keen, PhD, University of California, Davis; Department of Nutrition

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Microbiome; Honey; Phenolic; Yogurt
• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Body Weight; Inflammation; Overweight
• Other Study ID Numbers: 1492622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No