RECRUITING

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

Conditions

Overweight Phenolic Honey Inflammation Yogurt Microbiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-01

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04248127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Robert R Holt, PhD

CONTACT

530-752-4950

rrholt@ucdavis.edu

Principal Investigator

Carl L Keen, PhD

PRINCIPAL_INVESTIGATOR

University of California, Davis; Department of Nutrition

Study Locations (Sites)

University of California, Davis; Department of Nutrition

Davis, California, 95616

United States

Collaborators and Investigators

Sponsor: University of California, Davis

Carl L Keen, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis; Department of Nutrition

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-11-01

Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

Phenolic
Honey
Inflammation
Yogurt
Microbiome

Additional Relevant MeSH Terms

Overweight