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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248127
• Other study ID #: 1492622
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of California, Davis
• Contact: Robert R Holt, PhD
• Phone: 530-752-4950
• Email: rrholt[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Those qualified for enrollment will be randomized into a double-blind crossover study to consume 2 morning servings of a 0.6 cup (150g) of plain yogurt with : A) cane sugar added in an isocaloric level as the honey or, B) 1 tbsp of phenolic-rich honey for 4 weeks. A one-month washout between periods will be used. The participants will be instructed to consume one yogurt in replacement of or as part of breakfast, and as a late morning snack. They will also be instructed to not add any additional items to the yogurt. Therefore, each study participant will consume 2 tbsp. of honey a day for four weeks, which is a realistic amount typically consumed by honey users.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Overweight

Intervention

Other:
• Honey sweetened yogurt
2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions
• Sugar sweetened yogurt
sugar added, in an isocaloric fashion to the honey, to 1.2 cups of yogurt per day, split into two equal portions

Locations

Country	Name	City	State
United States	University of California, Davis; Department of Nutrition	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of CD4+ T Helper (TH)17 cytokines	Cytokines included in the panel are: Il-1b, IL-4, IL-6, IL-10, IL-17a, IL-21, IL-22, IL-23, IL-31, IL-33, IFN-gamma, TNF-alpha, IL-17f.	4 weeks
Secondary	Concentration of Secondary bile acids	plasma microbial metabolites	4 weeks
Secondary	Concentration of Short chain fatty acids	Fecal microbial metabolites	4 weeks
Secondary	Concentration of urolithins and other ellagitannin-derived metabolites	microbial metabolites	4 weeks
Secondary	Concentration of soluble NADPH oxidase (NOX2)	plasma marker oxidative stress	4 weeks
Secondary	Concentration of uric acid	plasma marker oxidative stress	4 weeks
Secondary	Concentration of total Nitrate/Nitrite and Nitric Oxide related metabolites (RSNO)	dietary nitrate and NO metabolites	4 weeks
Secondary	Concentration of untargeted metabolomics	metabolism	4 weeks
Secondary	Determination of microbial populations	stool bacterial population	4 weeks

External Links

•   Learn more or sign up for the study here!