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

NCT ID: NCT04248127

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Honey sweetened yogurt

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 Type: EXPERIMENTAL

Honey sweetened yogurt

Intervention Type: OTHER

2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions

Sugar sweetened yogurt

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.

Group Type: PLACEBO_COMPARATOR

Sugar sweetened yogurt

Intervention Type: OTHER

sugar added, in an isocaloric fashion to the honey, to 1.2 cups of yogurt per day, split into two equal portions

Interventions

Honey sweetened yogurt

2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl L Keen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis; Department of Nutrition

Locations

University of California, Davis; Department of Nutrition

Davis, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert R Holt, PhD

Role: CONTACT

rrholt@ucdavis.edu

530-752-4950

Facility Contacts

Roberta Holt, PhD

Role: primary

rrholt@ucdavis.edu

530-752-4950

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://studypages.com/s/join-this-nutrition-study-of-the-influence-of-honey-flavored-yogurt-on-gut-health-148082/

Learn more or sign up for the study here!

Other Identifiers

1492622

Identifier Type: -

Identifier Source: org_study_id