NCT01686204

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

4.1 years

First QC Date

September 12, 2012

Last Update Submit

September 29, 2017

Conditions

Intestinal Barrier FunctionChronic Inflammation

Keywords

YogurtIntestineInflammationObese

Outcome Measures

Primary Outcomes (1)

  • Plasma soluble cluster of differentiation 14 (sCD14)

    Fasting plasma sCD14 (change from baseline)

    0, 3, 6, and 9 wk

Secondary Outcomes (3)

  • Fasting plasma interleukin-6 (IL-6)

    0, 3, 6, 9 wk

  • Postprandial sCD14

    0 and 9 wk

  • Postprandial interleukin-6 (IL-6)

    0 and 9 wk

Other Outcomes (49)

  • Fasting lipopolysaccharide binding protein (LBP)

    0 and 9 wk

  • Fasting plasma endotoxin (LPS, lipopolysaccharide)

    0, 9 wk

  • Fasting plasma core antibodies to endotoxin

    0 and 9 wk

  • +46 more other outcomes

Study Arms (2)

Non-obese individuals

ACTIVE COMPARATOR

Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.

Other: Low fat dairy yogurtOther: Soy pudding

Obese individuals

EXPERIMENTAL

Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.

Other: Low fat dairy yogurtOther: Soy pudding

Interventions

Low fat dairy yogurtOTHER

Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks

Non-obese individualsObese individuals
Soy puddingOTHER

Consumption of 12 oz of low fat soy pudding daily for 9 weeks.

Non-obese individualsObese individuals

Eligibility Criteria

Age21 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science, Babcock Hall

Madison, Wisconsin, 53706, United States

Location

Related Publications (2)

  • Pei R, DiMarco DM, Putt KK, Martin DA, Chitchumroonchokchai C, Bruno RS, Bolling BW. Premeal Low-Fat Yogurt Consumption Reduces Postprandial Inflammation and Markers of Endotoxin Exposure in Healthy Premenopausal Women in a Randomized Controlled Trial. J Nutr. 2018 Jun 1;148(6):910-916. doi: 10.1093/jn/nxy046.

    PMID: 29767743DERIVED

  • Pei R, DiMarco DM, Putt KK, Martin DA, Gu Q, Chitchumroonchokchai C, White HM, Scarlett CO, Bruno RS, Bolling BW. Low-fat yogurt consumption reduces biomarkers of chronic inflammation and inhibits markers of endotoxin exposure in healthy premenopausal women: a randomised controlled trial. Br J Nutr. 2017 Dec;118(12):1043-1051. doi: 10.1017/S0007114517003038. Epub 2017 Nov 28.

    PMID: 29179781DERIVED

MeSH Terms

Conditions

InflammationObesity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • Bradley W Bolling, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 17, 2012

Study Start

September 1, 2012

Primary Completion

September 30, 2016

Study Completion

March 31, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

US(1)