Skip to main content
OpenTrials
Completed

NCT Number: NCT01686204

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intestinal Barrier Function Body Weight Chronic Inflammation Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food Science, Babcock Hall

Madison, Wisconsin, 53706, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low fat dairy yogurt

Other

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

Soy pudding

Other

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

Primary outcomes

  1. Plasma soluble cluster of differentiation 14 (sCD14)

    Time frame: 0, 3, 6, and 9 wk

    Fasting plasma sCD14 (change from baseline)

Secondary outcomes

  1. Fasting plasma interleukin-6 (IL-6)

    Time frame: 0, 3, 6, 9 wk

    Fasting plasma IL-6 (change from baseline)

  2. Postprandial sCD14

    Time frame: 0 and 9 wk

    Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)

  3. Postprandial interleukin-6 (IL-6)

    Time frame: 0 and 9 wk

    Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)

Other outcomes

  1. Fasting lipopolysaccharide binding protein (LBP)

    Time frame: 0 and 9 wk

    Determined by immunoassay

  2. Fasting plasma endotoxin (LPS, lipopolysaccharide)

    Time frame: 0, 9 wk

    Determined by limulus amebocyte lysate assay

  3. Fasting plasma core antibodies to endotoxin

    Time frame: 0 and 9 wk

    Immunoglobulin M Endotoxin-core antibody (IgM EndoCAb)

  4. Fasting plasma anandamide (AEA)

    Time frame: 0, 9 wk

    Determined by LC-MS

  5. Fasting plasma 2-arachidonoylglycerol (2-AG)

    Time frame: 0, 9 wk

    Determined by LC-MS

  6. Fasting plasma IL-10

    Time frame: 0, 9 wk

    Determined by immunoassay

  7. Fasting plasma high-sensitivity C-reactive protein (hsCRP)

    Time frame: 0, 9 wk

    Determined in fasting plasma

  8. Fasting plasma Tumor Necrosis Factor-alpha (TNF-α)

    Time frame: 0, 9 wk

    Determined in fasting plasma

  9. Fasting plasma Soluble TNF-Receptor II (sTNF-RII)

    Time frame: 0, 9 wk

    Determined in fasting plasma

  10. TNF-alpha/sTNF-RII ratio

    Time frame: 0, 9 wk

    Determined in fasting plasma

  11. Fasting plasma glucose

    Time frame: 0, 9 wk

    Determined in fasting plasma

  12. Fasting plasma triglycerides

    Time frame: 0, 9 wk

    Determined in fasting plasma

  13. Fasting plasma insulin

    Time frame: 0, 9 wk

    Determined in fasting plasma

  14. Fasting plasma soluble cluster of differentiation 14 (sCD14)

    Time frame: 0, 9 wk

    Determined in fasting plasma

  15. Body weight

    Time frame: 0, 3, 6, 9 wk

  16. Body mass index

    Time frame: 0, 3, 6, 9 wk

  17. Waist circumference

    Time frame: 0, 3, 6, 9 wk

  18. Systolic blood pressure

    Time frame: 0, 3, 6, 9 wk

  19. Diastolic blood pressure

    Time frame: 0, 3, 6, 9 wk

  20. Fasting RPLP0, encoding ribosomal protein large P0

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  21. TLR4, encoding Toll-like receptor 4

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  22. RELA, encoding p65 subunit of nuclear factor kappa B

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  23. NFKBIA, encoding nuclear factor kappa B inhibitor alpha

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  24. PTGS2, encoding cyclooxygenase-2 (COX-2)

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  25. NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase)

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  26. TNF, encoding tumor necrosis factors (TNF)

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  27. IFNG, encoding interferon-γ

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  28. TGFB1, encoding transforming growth factor beta 1 (TGFβ1)

    Time frame: 0, 9 wk

    mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)

  29. Postprandial plasma glucose

    Time frame: 0, 9 wk

    Postprandial plasma glucose following a high-fat, high-calorie challenge meal (area under curve)

  30. Postprandial plasma triglycerides

    Time frame: 0, 9 wk

    Postprandial plasma triglycerides following a high-fat, high-calorie challenge meal (area under curve)

  31. Postprandial lipopolysaccharide binding protein (LBP)

    Time frame: 0, 9 wk

    Postprandial plasma LBP following a high-fat, high-calorie challenge meal (area under curve)

  32. Postprandial lipopolysaccharide (LPS)

    Time frame: 0, 9 wk

    Postprandial plasma LPS following a high-fat, high-calorie challenge meal determined by limulus amebocyte lysate assay (area under curve)

  33. Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio

    Time frame: 0, 9 wk

    Postprandial LBP/sCD14 ratio following a high-fat, high-calorie challenge meal (area under curve)

  34. Postprandial plasma insulin

    Time frame: 0, 9 wk

    Postprandial plasma insulin following a high-fat, high-calorie challenge meal (area under curve)

  35. Energy intake (kcal)

    Time frame: 0, 9 wk

    Self-reported food intake determined by dietary records

  36. Total fat (g)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  37. Carbohydrate (g)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  38. Total protein (g)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  39. Total fat (%)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  40. Carbohydrate (%)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  41. Total protein (%)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  42. Cholestrol (mg)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  43. Saturated fatty acids (g)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  44. Vitamin D (μg)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  45. Calcium (mg)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  46. Sodium (mg)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  47. Potassium (mg)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  48. Total sugars (g)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

  49. Added sugars (g)

    Time frame: 0, 9 wk

    Self-reported nutrient intake determined by dietary records

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Dairy Research Institute

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Sep 17, 2012
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.