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OverweightNCT04248127

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

A study testing Honey sweetened yogurt and Sugar sweetened yogurt in people with Overweight, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Overweight
What is being tested?
Honey sweetened yogurt and Sugar sweetened yogurt
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Nov 2021to 21 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, Davis; Department of Nutrition

    Davis, California, 95616

Other trials in United States

About this study

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.

Read the 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.

Conditions
Overweight
Being tested
Honey sweetened yogurt, Sugar sweetened yogurt
Keywords
Phenolic, Honey, Inflammation, Yogurt, Microbiome
Medical subject headings
Overweight, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Honey sweetened yogurtOther

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

  • Sugar sweetened yogurtOther

    sugar added, in an isocaloric fashion to the honey, to 1.2 cups of yogurt per day, split into two equal portions

Study groups in NCT04248127
Study groupRoleWhat they receive
Honey sweetened yogurtExperimental1 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.
Receives: Other: Honey sweetened yogurt
Sugar sweetened yogurtPlacebo comparatorSugar 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.
Receives: Other: Sugar sweetened yogurt

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (8)

  1. Concentration of Secondary bile acids

    plasma microbial metabolites

    Measured: 4 weeks

  2. Concentration of Short chain fatty acids

    Fecal microbial metabolites

    Measured: 4 weeks

  3. Concentration of urolithins and other ellagitannin-derived metabolites

    microbial metabolites

    Measured: 4 weeks

  4. Concentration of soluble NADPH oxidase (NOX2)

    plasma marker oxidative stress

    Measured: 4 weeks

  5. Concentration of uric acid

    plasma marker oxidative stress

    Measured: 4 weeks

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

    dietary nitrate and NO metabolites

    Measured: 4 weeks

  7. Concentration of untargeted metabolomics

    metabolism

    Measured: 4 weeks

  8. Determination of microbial populations

    stool bacterial population

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start1 Nov 2021
  3. Primary completion21 May 2026
  4. Study completion21 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized single-blind 2-arm crossover trial. Each arm will be 4 weeks in length, with a 4 week washout between arms.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248127
Sponsor's protocol ID
1492622
Status last verified
Oct 2026
First submitted
4 Nov 2019
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Honey sweetened yogurt and Sugar sweetened yogurt in people with Overweight, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of CD4+ T Helper (TH)17 cytokines (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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