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Honey-Flavored Yogurt for Inflammation

N/A
Recruiting
Led By Carl L Keen, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal female: 45-65 years
Women: lack of menses for at least two years
Must not have
Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
Self-reported renal or liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Summary

This trial will test the effects of honey-flavored yogurt on inflammation, oxidative stress, and microbial metabolites.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include digestive discomfort due to dairy or honey intake and possible allergic reactions if participants have unknown allergies to ingredients in the yogurts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 45-65 and have gone through menopause.
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I have not had a menstrual period for at least two years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I take daily medication to thin my blood, including aspirin or NSAIDs.
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I have kidney or liver disease.
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I have a history of heart disease, including any heart attacks or strokes.
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I was diagnosed with cancer in the last 5 years.
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I limit my physical activities because of a long-term health issue.
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I have diabetes.
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I have problems absorbing nutrients from my food.
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I am not willing to stop taking supplements, including herbal and fish oil, a month before joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concentration of CD4+ T Helper (TH)17 cytokines
Secondary study objectives
Concentration of Secondary bile acids
Concentration of Short chain fatty acids
Concentration of soluble NADPH oxidase (NOX2)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Honey sweetened yogurtExperimental Treatment1 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 yogurtPlacebo Group1 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.

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Who is running the clinical trial?

University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,720,998 Total Patients Enrolled
31 Trials studying Obesity
33,674 Patients Enrolled for Obesity
Carl L Keen, PhDPrincipal InvestigatorUniversity of California, Davis; Department of Nutrition
15 Previous Clinical Trials
433 Total Patients Enrolled
1 Trials studying Obesity
21 Patients Enrolled for Obesity

Media Library

Honey-flavored Yogurt Clinical Trial Eligibility Overview. Trial Name: NCT04248127 — N/A
Obesity Research Study Groups: Honey sweetened yogurt, Sugar sweetened yogurt
~2 spots leftby Dec 2024