Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt

September 29, 2017 updated by: University of Wisconsin, Madison
The main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. Our central hypothesis is that short and long-term consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese individuals by improving intestinal barrier function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • Department of Food Science, Babcock Hall

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • premenopausal women
  • BMI from 18.5-27 and 30-40 kg/m2
  • resting blood pressure <140/90 mmHg
  • not taking medication to control hypertension
  • stable body weight for the previous 2 months
  • willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling
  • willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study

Exclusion Criteria:

  • previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis)
  • currently being treated for cancer (i.e., chemotherapy, radiation therapy)
  • prescribed estrogen replacement therapy
  • practicing weight-loss, vegetarian, kosher, or vegan diets
  • currently taking dietary supplements
  • exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week)
  • actively using antibiotics
  • taking anti-inflammatory drugs
  • have allergies to soy, egg or milk
  • perimenopausal or menopausal symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Non-obese individuals
Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
Other: Low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
Other: Soy pudding
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
Experimental: Obese individuals
Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.
Other: Low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
Other: Soy pudding
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma soluble cluster of differentiation 14 (sCD14)
Time Frame: 0, 3, 6, and 9 wk
Fasting plasma sCD14 (change from baseline)
0, 3, 6, and 9 wk

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting plasma interleukin-6 (IL-6)
Time Frame: 0, 3, 6, 9 wk
Fasting plasma IL-6 (change from baseline)
0, 3, 6, 9 wk
Postprandial sCD14
Time Frame: 0 and 9 wk
Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)
0 and 9 wk
Postprandial interleukin-6 (IL-6)
Time Frame: 0 and 9 wk
Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)
0 and 9 wk

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting lipopolysaccharide binding protein (LBP)
Time Frame: 0 and 9 wk
Determined by immunoassay
0 and 9 wk
Fasting plasma endotoxin (LPS, lipopolysaccharide)
Time Frame: 0, 9 wk
Determined by limulus amebocyte lysate assay
0, 9 wk
Fasting plasma core antibodies to endotoxin
Time Frame: 0 and 9 wk
Immunoglobulin M Endotoxin-core antibody (IgM EndoCAb)
0 and 9 wk
Fasting plasma anandamide (AEA)
Time Frame: 0, 9 wk
Determined by LC-MS
0, 9 wk
Fasting plasma 2-arachidonoylglycerol (2-AG)
Time Frame: 0, 9 wk
Determined by LC-MS
0, 9 wk
Fasting plasma IL-10
Time Frame: 0, 9 wk
Determined by immunoassay
0, 9 wk
Fasting plasma high-sensitivity C-reactive protein (hsCRP)
Time Frame: 0, 9 wk
Determined in fasting plasma
0, 9 wk
Fasting plasma Tumor Necrosis Factor-alpha (TNF-α)
Time Frame: 0, 9 wk
Determined in fasting plasma
0, 9 wk
Fasting plasma Soluble TNF-Receptor II (sTNF-RII)
Time Frame: 0, 9 wk
Determined in fasting plasma
0, 9 wk
TNF-alpha/sTNF-RII ratio
Time Frame: 0, 9 wk
Determined in fasting plasma
0, 9 wk
Fasting plasma glucose
Time Frame: 0, 9 wk
Determined in fasting plasma
0, 9 wk
Fasting plasma triglycerides
Time Frame: 0, 9 wk
Determined in fasting plasma
0, 9 wk
Fasting plasma insulin
Time Frame: 0, 9 wk
Determined in fasting plasma
0, 9 wk
Fasting plasma soluble cluster of differentiation 14 (sCD14)
Time Frame: 0, 9 wk
Determined in fasting plasma
0, 9 wk
Body weight
Time Frame: 0, 3, 6, 9 wk
0, 3, 6, 9 wk
Body mass index
Time Frame: 0, 3, 6, 9 wk
0, 3, 6, 9 wk
Waist circumference
Time Frame: 0, 3, 6, 9 wk
0, 3, 6, 9 wk
Systolic blood pressure
Time Frame: 0, 3, 6, 9 wk
0, 3, 6, 9 wk
Diastolic blood pressure
Time Frame: 0, 3, 6, 9 wk
0, 3, 6, 9 wk
Fasting RPLP0, encoding ribosomal protein large P0
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
TLR4, encoding Toll-like receptor 4
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
RELA, encoding p65 subunit of nuclear factor kappa B
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
NFKBIA, encoding nuclear factor kappa B inhibitor alpha
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
PTGS2, encoding cyclooxygenase-2 (COX-2)
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase)
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
TNF, encoding tumor necrosis factors (TNF)
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
IFNG, encoding interferon-γ
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
TGFB1, encoding transforming growth factor beta 1 (TGFβ1)
Time Frame: 0, 9 wk
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
0, 9 wk
Postprandial plasma glucose
Time Frame: 0, 9 wk
Postprandial plasma glucose following a high-fat, high-calorie challenge meal (area under curve)
0, 9 wk
Postprandial plasma triglycerides
Time Frame: 0, 9 wk
Postprandial plasma triglycerides following a high-fat, high-calorie challenge meal (area under curve)
0, 9 wk
Postprandial lipopolysaccharide binding protein (LBP)
Time Frame: 0, 9 wk
Postprandial plasma LBP following a high-fat, high-calorie challenge meal (area under curve)
0, 9 wk
Postprandial lipopolysaccharide (LPS)
Time Frame: 0, 9 wk
Postprandial plasma LPS following a high-fat, high-calorie challenge meal determined by limulus amebocyte lysate assay (area under curve)
0, 9 wk
Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio
Time Frame: 0, 9 wk
Postprandial LBP/sCD14 ratio following a high-fat, high-calorie challenge meal (area under curve)
0, 9 wk
Postprandial plasma insulin
Time Frame: 0, 9 wk
Postprandial plasma insulin following a high-fat, high-calorie challenge meal (area under curve)
0, 9 wk
Energy intake (kcal)
Time Frame: 0, 9 wk
Self-reported food intake determined by dietary records
0, 9 wk
Total fat (g)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Carbohydrate (g)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Total protein (g)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Total fat (%)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Carbohydrate (%)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Total protein (%)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Cholestrol (mg)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Saturated fatty acids (g)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Vitamin D (μg)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Calcium (mg)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Sodium (mg)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Potassium (mg)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Total sugars (g)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk
Added sugars (g)
Time Frame: 0, 9 wk
Self-reported nutrient intake determined by dietary records
0, 9 wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dairy Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bradley W Bolling, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-0669

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