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

Primary Purpose

Overweight

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Honey sweetened yogurt

Sugar sweetened yogurt

About this trial

This is an interventional prevention trial for Overweight focused on measuring Phenolic, Honey, Inflammation, Yogurt, Microbiome

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

University of California, Davis; Department of NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Honey sweetened yogurt

Sugar sweetened yogurt

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Concentration of Secondary bile acids

plasma microbial metabolites

Concentration of Short chain fatty acids

Fecal microbial metabolites

Concentration of urolithins and other ellagitannin-derived metabolites

microbial metabolites

Concentration of soluble NADPH oxidase (NOX2)

plasma marker oxidative stress

Concentration of uric acid

plasma marker oxidative stress

Concentration of total Nitrate/Nitrite and Nitric Oxide related metabolites (RSNO)

dietary nitrate and NO metabolites

Concentration of untargeted metabolomics

metabolism

Determination of microbial populations

stool bacterial population

Full Information

NCT ID

NCT04248127

First Posted

November 4, 2019

Last Updated

May 9, 2023

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT04248127

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

Keywords

Phenolic, Honey, Inflammation, Yogurt, Microbiome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized single-blind 2-arm crossover trial. Each arm will be 4 weeks in length, with a 4 week washout between arms.

Masking

Participant

Masking Description

The honey intervention or isocaloric amounts of sugar will be provided in yogurt. The study participant will not be told what sweetener they will be receiving.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Honey sweetened yogurt

Arm Type

Experimental

Arm Description

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.

Arm Title

Sugar sweetened yogurt

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Honey sweetened yogurt

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sugar sweetened yogurt

Intervention Description

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

Primary Outcome Measure Information:

Title

Concentration of CD4+ T Helper (TH)17 cytokines

Description

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.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Concentration of Secondary bile acids

Description

plasma microbial metabolites

Time Frame

4 weeks

Title

Concentration of Short chain fatty acids

Description

Fecal microbial metabolites

Time Frame

4 weeks

Title

Concentration of urolithins and other ellagitannin-derived metabolites

Description

microbial metabolites

Time Frame

4 weeks

Title

Concentration of soluble NADPH oxidase (NOX2)

Description

plasma marker oxidative stress

Time Frame

4 weeks

Title

Concentration of uric acid

Description

plasma marker oxidative stress

Time Frame

4 weeks

Title

Concentration of total Nitrate/Nitrite and Nitric Oxide related metabolites (RSNO)

Description

dietary nitrate and NO metabolites

Time Frame

4 weeks

Title

Concentration of untargeted metabolomics

Description

metabolism

Time Frame

4 weeks

Title

Determination of microbial populations

Description

stool bacterial population

Time Frame

4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert R Holt, PhD

Phone

530-752-4950

rrholt@ucdavis.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl L Keen, PhD

Organizational Affiliation

University of California, Davis; Department of Nutrition

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Davis; Department of Nutrition

City

Davis

State/Province

California

ZIP/Postal Code

95616

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberta Holt, PhD

Phone

530-752-4950

rrholt@ucdavis.edu

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

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

Description

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

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