Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01686204
Recruitment Status : Completed
First Posted : September 17, 2012
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Intestinal Barrier Function Chronic Inflammation Other: Low fat dairy yogurt Other: Soy pudding Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
Study Start Date : September 2012
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : March 31, 2017

Arm Intervention/treatment
Active Comparator: Non-obese individuals
Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
Other: Low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks

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

Experimental: Obese individuals
Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.
Other: Low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks

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




Primary Outcome Measures :
  1. Plasma soluble cluster of differentiation 14 (sCD14) [ Time Frame: 0, 3, 6, and 9 wk ]
    Fasting plasma sCD14 (change from baseline)


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686204


Locations
Layout table for location information
United States, Wisconsin
Department of Food Science, Babcock Hall
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Dairy Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Bradley W Bolling, PhD University of Wisconsin, Madison

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01686204     History of Changes
Other Study ID Numbers: 2014-0669
First Posted: September 17, 2012    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by University of Wisconsin, Madison:
Yogurt
Intestine
Inflammation
Obese

Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Pathologic Processes