Effects of honey-flavored yogurt on inflammation and gut health in older women
The Influence of Honey-flavored Yogurt on Low-grade Inflammation and Gut Health in Middle to Older Aged Women.
This study tests if eating honey-flavored yogurt every day can help reduce inflammation and improve gut health in postmenopausal women aged 45-65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Davis, California) |
| Trial ID | NCT04248127 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of daily consumption of honey-flavored yogurt on low-grade inflammation and gut health in postmenopausal women aged 45-65. Participants will be randomly assigned to consume either honey-sweetened yogurt or sugar-sweetened yogurt for four weeks, followed by a washout period. The study aims to measure changes in inflammatory markers, oxidative stress, and gut microbiome composition resulting from the dietary intervention. By analyzing these factors, the trial seeks to understand the relationship between diet and systemic health in this demographic.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 45-65 with a BMI between 25.0 and 30.0 kg/m2.
Not a fit: Patients with a BMI of 31 kg/m2 or higher, those with chronic health conditions, or those on specific diets may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that reduce inflammation and improve gut health in middle to older aged women.
How similar studies have performed: While there have been studies on dietary interventions for inflammation, this specific approach using honey-flavored yogurt is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Davis, California
- University of California, Davis; Department of Nutrition — Davis, California, United States (Recruiting)
Study contacts
- Principal investigator: Carl L Keen, PhD — University of California, Davis; Department of Nutrition
- Study coordinator: Robert R Holt, PhD
- Email: rrholt@ucdavis.edu
- Phone: 530-752-4950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.