Yogurt for Prevention of Chronic Inflammation

NCT ID: NCT04149418

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-09-01

Brief Summary

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The objective of this study is to conduct a randomized cross-over dietary intervention in adult women who are overweight or obese to compare how yogurt and a control food affect biomarkers of inflammation and intestinal health.

Detailed Description

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Conditions

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Obesity Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Yogurt-Control

Consumption of 12 oz. of low-fat yogurt daily (2 x 6 oz. servings) for 4 weeks, followed by a washout phase for 4 weeks, then consumption of 12 oz. control food (flavored soy pudding, 2 x 6 oz. servings) for 4 weeks.

Group Type EXPERIMENTAL

Yogurt

Intervention Type OTHER

Low-fat flavored yogurt

Control food

Intervention Type OTHER

Low-fat flavored soy pudding

Control-Yogurt

Consumption of control food (flavored soy pudding, 2 x 6 oz. servings), followed by a washout phase for 4 weeks, then consumption of 12 oz. of low-fat yogurt daily (2 x 6 oz. servings) for 4 weeks.

Group Type EXPERIMENTAL

Yogurt

Intervention Type OTHER

Low-fat flavored yogurt

Control food

Intervention Type OTHER

Low-fat flavored soy pudding

Interventions

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Yogurt

Low-fat flavored yogurt

Intervention Type OTHER

Control food

Low-fat flavored soy pudding

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy premenopausal women age 21-55
* BMI ≥ 25 kg/m2
* not taking medication to control hypertension (e.g. anti-hypertensives or diuretics)
* resting blood pressure \<140/90 mmHg
* stable body weight for past two months
* willing to maintain a normal exercise level (in general)
* willing to avoid exercise and smoking (or other forms of nicotine intake) for 24 h prior to blood collection
* willing to avoid caffeine for 12 h before study visits
* willing to fast 12 h prior to study visits
* willing to avoid dietary supplements, yogurt and probiotic-containing foods (as necessary) and consume 12 oz. of yogurt and the control food per day (as necessary) for the duration of the study

Exclusion Criteria

* self-reported previous diagnoses of an inflammatory disease (e.g. inflammatory bowel disease, asthma, arthritis), CVD, diabetes, current cancer treatment (i.e., chemotherapy, radiation therapy)
* have used oral antibiotics in the prior 21 days before sample collection
* actively trying to lose weight
* regularly taking anti-inflammatory drugs
* vegetarian or allergic to soy or dairy
* are pregnant, lactating, or trying to become pregnant
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Dairy Council

OTHER

Sponsor Role collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradley W Bolling, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Department of Food Science, Babcock Hall

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Hasegawa Y, Noll AL, Lang DJ, Akfaly EM, Liu Z, Bolling BW. Low-fat yogurt consumption maintains biomarkers of immune function relative to nondairy control food in women with elevated BMI: A randomized controlled crossover trial. Nutr Res. 2024 Sep;129:1-13. doi: 10.1016/j.nutres.2024.07.005. Epub 2024 Jul 24.

Reference Type DERIVED
PMID: 39153426 (View on PubMed)

Other Identifiers

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A074000

Identifier Type: OTHER

Identifier Source: secondary_id

AG&LSC/FOOD SCIENCE/FOOD SCIEN

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 1/10/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2018-1262

Identifier Type: -

Identifier Source: org_study_id

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