Honey-Flavored Yogurt for Inflammation

Overseen By Robert R Holt, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Anticoagulants, NSAIDs, Supplements

Disqualifiers: Diabetes, Heart disease, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription drugs or supplements, except for a general formula of vitamins and minerals that meet the recommended daily allowance (RDA), at least a month before joining the study.

Is honey-flavored yogurt safe for human consumption?

Research on yogurt consumption, including flavored varieties, suggests it is generally safe for humans and may even have health benefits, such as reducing inflammation and supporting gut health, without undesirable side effects. ^{1 2 3 4 5}

How does honey-flavored yogurt differ from other treatments for inflammation?

Honey-flavored yogurt is unique because it combines the anti-inflammatory properties of yogurt with the potential benefits of honey, which is known for its antioxidant and antimicrobial effects. This combination may offer a novel approach to reducing inflammation by modulating immune responses and improving gut health, unlike standard treatments that may not address these specific mechanisms. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Honey-flavored Yogurt for inflammation?

Research shows that honey has anti-inflammatory properties, as it can reduce markers of inflammation and promote beneficial gut bacteria. This suggests that honey-flavored yogurt might help reduce inflammation by leveraging these properties of honey. ^{9 10 11 12 13}

Who Is on the Research Team?

Carl L Keen, PhD

Principal Investigator

University of California, Davis; Department of Nutrition

Are You a Good Fit for This Trial?

This trial is for postmenopausal women aged 45-65 with a BMI of 25.0 - 30.0 kg/m2 who are willing to follow the study protocols. It's not suitable for those with recent cancer, high blood pressure, heart disease, liver or kidney issues, certain dietary restrictions (vegans/vegetarians), or taking various supplements and medications.

Inclusion Criteria

I am a woman aged 45-65 and have gone through menopause.

Subject is willing to participate in all study procedures

I have not had a menstrual period for at least two years.

Exclusion Criteria

You regularly engage in intense exercise.

You are not allowed to use concentrated food supplements, powders, or extracts during the study.

I take daily medication to thin my blood, including aspirin or NSAIDs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 2 morning servings of honey-flavored or sugar-flavored yogurt daily for 4 weeks

4 weeks

Weekly check-ins (virtual)

Washout

A one-month washout period between crossover phases

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Honey-flavored Yogurt
• Sugar sweetened yogurt

Trial Overview The study aims to compare the effects of honey-flavored yogurt versus sugar-sweetened yogurt on inflammation and gut health over four weeks. It will measure changes in inflammatory markers, oxidative stress levels, metabolism, and gut microbiome in middle-aged women.

How Is the Trial Designed?

Group I: Honey sweetened yogurt Experimental Treatment 1 Intervention

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.

Group II: Sugar sweetened yogurt Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

In a study involving 37 healthy participants over two 4-week trials, honey consumption led to significantly lower energy, carbohydrate, and sugar intake compared to sucrose, suggesting it may be a healthier alternative.

While both honey and sucrose initially raised serum triglyceride levels, only sucrose maintained this elevation after 4 weeks, indicating that honey may have a more favorable impact on lipid profiles over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Honey does not adversely impact blood lipids of adult men and women: a randomized cross-over trial. Al-Tamimi, AM., Petrisko, M., Hong, MY., et al.[2021]

A survey of 47 yogurt samples from six brands in mid-Michigan revealed significant variations in protein, fat, and total solids content, indicating a lack of consistency in yogurt composition.

About 25% of the yogurt samples were found to be overweight by more than 6.6%, and 10.6% weighed less than the declared net weight, suggesting a need for better quality control in commercial yogurt products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yogurt - A Compositional Survey in the Greater Lansing Area 1. Richmond, ML., Chandan, RC., Stine, CM.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Honeys with anti-inflammatory capacity can alter the elderly gut microbiota in an ex vivo gut model. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Honey and its nutritional and anti-inflammatory value. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse effects of honey on low-density lipoprotein cholesterol and adiponectin concentrations in patients with type 2 diabetes: a randomized controlled cross-over trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Honey does not adversely impact blood lipids of adult men and women: a randomized cross-over trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of Honey on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Consumer rejection threshold, acceptability rates, physicochemical properties, and shelf-life of strawberry-flavored yogurts with reductions of sugar. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Yoghurt consumption regulates the immune cells implicated in acute intestinal inflammation and prevents the recurrence of the inflammatory process in a mouse model. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Yogurt Supplementation Attenuates Insulin Resistance in Obese Mice by Reducing Metabolic Endotoxemia and Inflammation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Yogurt consumption and impact on health: focus on children and cardiometabolic risk. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Yogurt - A Compositional Survey in the Greater Lansing Area 1. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Suppression of tumorigenesis: modulation of inflammatory cytokines by oral administration of microencapsulated probiotic yogurt formulation. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Low-fat yogurt consumption reduces biomarkers of chronic inflammation and inhibits markers of endotoxin exposure in healthy premenopausal women: a randomised controlled trial. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Influences of Yogurt with Functional Ingredients from Various Sources That Help Treat Leaky Gut on Intestinal Barrier Dysfunction in Caco-2 Cells. [2023]