Yogurt for Prevention of Chronic Inflammation

University of Wisconsin (UW)

Status: Completed

Conditions: Inflammation; Obesity

Treatments: Other: Control food; Other: Yogurt

Study type: Interventional

Funder types: Other

Identifiers

NCT04149418

AG&LSC/FOOD SCIENCE/FOOD SCIEN (Other Identifier)

Protocol Version 1/10/2019 (Other Identifier)

2018-1262

A074000 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Yogurt-Control

Experimental group

Description:

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.

Treatment:

Other: Control food

Other: Yogurt

Control-Yogurt

Experimental group

Description:

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.

Treatment:

Other: Control food

Other: Yogurt