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

NCT04248127 | Recruiting

• 1 other identifier: 1492622
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Keywords

Phenolic; Honey; Inflammation; Yogurt; Microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Concentration of Secondary bile acids

  4 weeks

• Concentration of Short chain fatty acids

  4 weeks

• Concentration of urolithins and other ellagitannin-derived metabolites

  4 weeks

• Concentration of soluble NADPH oxidase (NOX2)

  4 weeks

• Concentration of uric acid

  4 weeks

Study Arms (2)

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.

Other: Honey sweetened yogurt

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.

Other: Sugar sweetened yogurt

Interventions

Honey sweetened yogurt OTHER

2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions

Honey sweetened yogurt

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

Sugar sweetened yogurt

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis; Department of Nutrition

Davis, California, 95616, United States

RECRUITING

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Overweight; Inflammation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Carl L Keen, PhD

  University of California, Davis; Department of Nutrition

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert R Holt, PhD

CONTACT

530-752-4950; rrholt@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized single-blind 2-arm crossover trial. Each arm will be 4 weeks in length, with a 4 week washout between arms.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: January 30, 2020
• Study Start: November 1, 2021
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)