Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248127
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Overweight Other: Honey sweetened yogurt Other: Sugar sweetened yogurt Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (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.
Primary Purpose: Prevention
Official Title: The Influence of Honey-flavored Yogurt on Low-grade Inflammation and Gut Health in Middle to Older Aged Women.
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : April 30, 2024

Arm Intervention/treatment
Experimental: 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.
Other: Honey sweetened yogurt
2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions

Placebo Comparator: 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.
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




Primary Outcome Measures :
  1. Concentration of CD4+ T Helper (TH)17 cytokines [ Time Frame: 4 weeks ]
    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 :
  1. Concentration of Secondary bile acids [ Time Frame: 4 weeks ]
    plasma microbial metabolites

  2. Concentration of Short chain fatty acids [ Time Frame: 4 weeks ]
    Fecal microbial metabolites

  3. Concentration of urolithins and other ellagitannin-derived metabolites [ Time Frame: 4 weeks ]
    microbial metabolites

  4. Concentration of soluble NADPH oxidase (NOX2) [ Time Frame: 4 weeks ]
    plasma marker oxidative stress

  5. Concentration of uric acid [ Time Frame: 4 weeks ]
    plasma marker oxidative stress

  6. Concentration of total Nitrate/Nitrite and Nitric Oxide related metabolites (RSNO) [ Time Frame: 4 weeks ]
    dietary nitrate and NO metabolites

  7. Concentration of untargeted metabolomics [ Time Frame: 4 weeks ]
    metabolism

  8. Determination of microbial populations [ Time Frame: 4 weeks ]
    stool bacterial population



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248127


Contacts
Layout table for location contacts
Contact: Robert R Holt, PhD 530-752-4950 rrholt@ucdavis.edu

Locations
Layout table for location information
United States, California
University of California, Davis; Department of Nutrition Recruiting
Davis, California, United States, 95616
Contact: Roberta Holt, PhD    530-752-4950    rrholt@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
Layout table for investigator information
Principal Investigator: Carl L Keen, PhD University of California, Davis; Department of Nutrition
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Additional Information:
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04248127    
Other Study ID Numbers: 1492622
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Phenolic
Honey
Inflammation
Yogurt
Microbiome
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Overweight
Pathologic Processes
Body Weight