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

Chronic Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686204
• Other study ID #: 2014-0669
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: September 29, 2017
• Start date: September 2012
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 31, 2017
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Inflammation
• Inflammation
• Intestinal Barrier Function

Intervention

Other:
• Low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
• Soy pudding
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.

Locations

Country	Name	City	State
United States	Department of Food Science, Babcock Hall	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Dairy Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting lipopolysaccharide binding protein (LBP)	Determined by immunoassay	0 and 9 wk
Other	Fasting plasma endotoxin (LPS, lipopolysaccharide)	Determined by limulus amebocyte lysate assay	0, 9 wk
Other	Fasting plasma core antibodies to endotoxin	Immunoglobulin M Endotoxin-core antibody (IgM EndoCAb)	0 and 9 wk
Other	Fasting plasma anandamide (AEA)	Determined by LC-MS	0, 9 wk
Other	Fasting plasma 2-arachidonoylglycerol (2-AG)	Determined by LC-MS	0, 9 wk
Other	Fasting plasma IL-10	Determined by immunoassay	0, 9 wk
Other	Fasting plasma high-sensitivity C-reactive protein (hsCRP)	Determined in fasting plasma	0, 9 wk
Other	Fasting plasma Tumor Necrosis Factor-alpha (TNF-a)	Determined in fasting plasma	0, 9 wk
Other	Fasting plasma Soluble TNF-Receptor II (sTNF-RII)	Determined in fasting plasma	0, 9 wk
Other	TNF-alpha/sTNF-RII ratio	Determined in fasting plasma	0, 9 wk
Other	Fasting plasma glucose	Determined in fasting plasma	0, 9 wk
Other	Fasting plasma triglycerides	Determined in fasting plasma	0, 9 wk
Other	Fasting plasma insulin	Determined in fasting plasma	0, 9 wk
Other	Fasting plasma soluble cluster of differentiation 14 (sCD14)	Determined in fasting plasma	0, 9 wk
Other	Body weight		0, 3, 6, 9 wk
Other	Body mass index		0, 3, 6, 9 wk
Other	Waist circumference		0, 3, 6, 9 wk
Other	Systolic blood pressure		0, 3, 6, 9 wk
Other	Diastolic blood pressure		0, 3, 6, 9 wk
Other	Fasting RPLP0, encoding ribosomal protein large P0	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	TLR4, encoding Toll-like receptor 4	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	RELA, encoding p65 subunit of nuclear factor kappa B	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	NFKBIA, encoding nuclear factor kappa B inhibitor alpha	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	PTGS2, encoding cyclooxygenase-2 (COX-2)	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase)	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	TNF, encoding tumor necrosis factors (TNF)	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	IFNG, encoding interferon-?	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	TGFB1, encoding transforming growth factor beta 1 (TGFß1)	mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)	0, 9 wk
Other	Postprandial plasma glucose	Postprandial plasma glucose following a high-fat, high-calorie challenge meal (area under curve)	0, 9 wk
Other	Postprandial plasma triglycerides	Postprandial plasma triglycerides following a high-fat, high-calorie challenge meal (area under curve)	0, 9 wk
Other	Postprandial lipopolysaccharide binding protein (LBP)	Postprandial plasma LBP following a high-fat, high-calorie challenge meal (area under curve)	0, 9 wk
Other	Postprandial lipopolysaccharide (LPS)	Postprandial plasma LPS following a high-fat, high-calorie challenge meal determined by limulus amebocyte lysate assay (area under curve)	0, 9 wk
Other	Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio	Postprandial LBP/sCD14 ratio following a high-fat, high-calorie challenge meal (area under curve)	0, 9 wk
Other	Postprandial plasma insulin	Postprandial plasma insulin following a high-fat, high-calorie challenge meal (area under curve)	0, 9 wk
Other	Energy intake (kcal)	Self-reported food intake determined by dietary records	0, 9 wk
Other	Total fat (g)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Carbohydrate (g)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Total protein (g)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Total fat (%)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Carbohydrate (%)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Total protein (%)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Cholestrol (mg)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Saturated fatty acids (g)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Vitamin D (µg)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Calcium (mg)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Sodium (mg)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Potassium (mg)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Total sugars (g)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Other	Added sugars (g)	Self-reported nutrient intake determined by dietary records	0, 9 wk
Primary	Plasma soluble cluster of differentiation 14 (sCD14)	Fasting plasma sCD14 (change from baseline)	0, 3, 6, and 9 wk
Secondary	Fasting plasma interleukin-6 (IL-6)	Fasting plasma IL-6 (change from baseline)	0, 3, 6, 9 wk
Secondary	Postprandial sCD14	Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)	0 and 9 wk
Secondary	Postprandial interleukin-6 (IL-6)	Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)	0 and 9 wk