Recruiting

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

Sponsor:

UCLA

Code:

NCT04248127

Conditions

Overweight

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Accepted

Interventions

Honey sweetened yogurt

Sugar sweetened yogurt

Study Details

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

Study ID

NCT04248127

Start date

Nov 1, 2021

Status verified date

Feb, 2026

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 25, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Honey sweetened yogurt

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

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

Primary outcome measure

Concentration of CD4+ T Helper (TH)17 cytokines [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Robert R Holt, PhD

530-752-4950 rrholt@ucdavis.edu

Locations

University of California, Davis; Department of Nutrition

Recruiting

Davis, California, United States, 95616

Contacts

Roberta Holt, PhD

530-752-4950 rrholt@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

Phenolic
Honey
Inflammation
Yogurt
Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-02-10.