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

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Jan 28, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how eating honey-flavored yogurt every day for four weeks may affect low-grade inflammation and gut health in women aged 45 to 65 who are overweight. The researchers want to see if this yogurt can help reduce inflammation in the body and improve gut health by looking at certain markers in the blood and changes in gut bacteria. This study is important because it could uncover how simple dietary changes might benefit health, particularly for women in this age group.

To participate in the trial, women must be postmenopausal, meaning they have not had a menstrual period for at least two years, and have a body mass index (BMI) between 25.0 and 30.0. Participants should be willing to follow the study rules and attend all necessary procedures. Throughout the study, participants can expect to consume the yogurt daily and provide samples for testing to help researchers understand the effects of this dietary change. If you are interested in joining and meet the eligibility criteria, this could be a great opportunity to contribute to research that may help improve health for many women.

Gender

FEMALE

Eligibility 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.