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NCT Number: NCT04248127

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis; Department of Nutrition

Davis, California, 95616, United States

Location status: Recruiting

Location contact

Roberta Holt, PhD

CONTACT

[email protected]

530-752-4950

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Honey sweetened yogurt

Other

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

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

Primary outcomes

  1. Concentration of CD4+ T Helper (TH)17 cytokines

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Concentration of Secondary bile acids

    Time frame: 4 weeks

    plasma microbial metabolites

  2. Concentration of Short chain fatty acids

    Time frame: 4 weeks

    Fecal microbial metabolites

  3. Concentration of urolithins and other ellagitannin-derived metabolites

    Time frame: 4 weeks

    microbial metabolites

  4. Concentration of soluble NADPH oxidase (NOX2)

    Time frame: 4 weeks

    plasma marker oxidative stress

  5. Concentration of uric acid

    Time frame: 4 weeks

    plasma marker oxidative stress

  6. Concentration of total Nitrate/Nitrite and Nitric Oxide related metabolites (RSNO)

    Time frame: 4 weeks

    dietary nitrate and NO metabolites

  7. Concentration of untargeted metabolomics

    Time frame: 4 weeks

    metabolism

  8. Determination of microbial populations

    Time frame: 4 weeks

    stool bacterial population

Study contacts

Contact information is provided by the study sponsor or research team.

Robert R Holt, PhD

CONTACT

[email protected]

530-752-4950

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2020
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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