Chronic Inflammation, Intestinal Barrier Function
Conditions
Keywords
Yogurt, Intestine, Inflammation, Obese
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.
Interventions
OTHERLow fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
OTHERSoy pudding
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
Sponsors
Dairy Research Institute
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma soluble cluster of differentiation 14 (sCD14) | 0, 3, 6, and 9 wk | Fasting plasma sCD14 (change from baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma interleukin-6 (IL-6) | 0, 3, 6, 9 wk | Fasting plasma IL-6 (change from baseline) |
| Postprandial sCD14 | 0 and 9 wk | Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve) |
| Postprandial interleukin-6 (IL-6) | 0 and 9 wk | Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma high-sensitivity C-reactive protein (hsCRP) | 0, 9 wk | Determined in fasting plasma |
| Fasting lipopolysaccharide binding protein (LBP) | 0 and 9 wk | Determined by immunoassay |
| Fasting plasma endotoxin (LPS, lipopolysaccharide) | 0, 9 wk | Determined by limulus amebocyte lysate assay |
| Fasting plasma core antibodies to endotoxin | 0 and 9 wk | Immunoglobulin M Endotoxin-core antibody (IgM EndoCAb) |
| Fasting plasma anandamide (AEA) | 0, 9 wk | Determined by LC-MS |
| Fasting plasma Soluble TNF-Receptor II (sTNF-RII) | 0, 9 wk | Determined in fasting plasma |
| TNF-alpha/sTNF-RII ratio | 0, 9 wk | Determined in fasting plasma |
| Fasting plasma glucose | 0, 9 wk | Determined in fasting plasma |
| Fasting plasma triglycerides | 0, 9 wk | Determined in fasting plasma |
| Fasting plasma insulin | 0, 9 wk | Determined in fasting plasma |
| Fasting plasma soluble cluster of differentiation 14 (sCD14) | 0, 9 wk | Determined in fasting plasma |
| Body weight | 0, 3, 6, 9 wk | — |
| Body mass index | 0, 3, 6, 9 wk | — |
| Waist circumference | 0, 3, 6, 9 wk | — |
| Systolic blood pressure | 0, 3, 6, 9 wk | — |
| Fasting RPLP0, encoding ribosomal protein large P0 | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| TLR4, encoding Toll-like receptor 4 | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| RELA, encoding p65 subunit of nuclear factor kappa B | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| NFKBIA, encoding nuclear factor kappa B inhibitor alpha | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| PTGS2, encoding cyclooxygenase-2 (COX-2) | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase) | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| TNF, encoding tumor necrosis factors (TNF) | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| IFNG, encoding interferon-γ | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| TGFB1, encoding transforming growth factor beta 1 (TGFβ1) | 0, 9 wk | mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5) |
| Postprandial plasma glucose | 0, 9 wk | Postprandial plasma glucose following a high-fat, high-calorie challenge meal (area under curve) |
| Postprandial plasma triglycerides | 0, 9 wk | Postprandial plasma triglycerides following a high-fat, high-calorie challenge meal (area under curve) |
| Postprandial lipopolysaccharide binding protein (LBP) | 0, 9 wk | Postprandial plasma LBP following a high-fat, high-calorie challenge meal (area under curve) |
| Postprandial lipopolysaccharide (LPS) | 0, 9 wk | Postprandial plasma LPS following a high-fat, high-calorie challenge meal determined by limulus amebocyte lysate assay (area under curve) |
| Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio | 0, 9 wk | Postprandial LBP/sCD14 ratio following a high-fat, high-calorie challenge meal (area under curve) |
| Postprandial plasma insulin | 0, 9 wk | Postprandial plasma insulin following a high-fat, high-calorie challenge meal (area under curve) |
| Energy intake (kcal) | 0, 9 wk | Self-reported food intake determined by dietary records |
| Total fat (g) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Carbohydrate (g) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Total protein (g) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Total fat (%) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Carbohydrate (%) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Total protein (%) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Cholestrol (mg) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Saturated fatty acids (g) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Vitamin D (μg) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Calcium (mg) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Sodium (mg) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Fasting plasma Tumor Necrosis Factor-alpha (TNF-α) | 0, 9 wk | Determined in fasting plasma |
| Total sugars (g) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Added sugars (g) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Potassium (mg) | 0, 9 wk | Self-reported nutrient intake determined by dietary records |
| Diastolic blood pressure | 0, 3, 6, 9 wk | — |
| Fasting plasma 2-arachidonoylglycerol (2-AG) | 0, 9 wk | Determined by LC-MS |
| Fasting plasma IL-10 | 0, 9 wk | Determined by immunoassay |
Countries
United States
Outcome results
None listed