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Official title The Influence of Honey-flavored Yogurt on Low-grade Inflammation and Gut Health in Middle to Older Aged Women.
ClinicalTrials.gov ID: NCT04248127
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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...
- 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...
- Current enrollee in a clinical research study.
The study team makes the final eligibility decision.
Where it's taking place
- Davis, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Davis, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.