Milk Fat Intake and Metabolic Health Markers (DMFMHM)
|ClinicalTrials.gov Identifier: NCT02659748|
Recruitment Status : Unknown
Verified October 2016 by Jana Kraft, University of Vermont.
Recruitment status was: Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Insulin Sensitivity Type 2 Diabetes||Dietary Supplement: Milk Fat Dietary Supplement: Control Fat||Not Applicable|
Saturated fats impair the action of insulin leading to abnormally high blood sugar levels that are characteristic of diabetes. Since milk fat is high in saturated fat, some experts advise against whole dairy products (e.g., milk and yogurt). However, bioactive fats, such as those which occur in milk fat, may be beneficial in the prevention of diabetes.
Current data provide no compelling evidence that a moderate intake of saturated fat from milk fat increases the risk of diabetes. Milk fat contains a unique variety of bioactive fats, which may be beneficial and may counterbalance the potential negative effects of saturated fat.
The investigators hypothesize that milk fat has favorable effects on metabolic risk markers associated with the metabolic syndrome. Therefore, this study tests the hypothesis that milk-fat intake will:
(i) result in improved insulin sensitivity,
(ii) favorably alter postprandial lipid metabolism, and
(iii) result in lower circulating concentrations of pro-inflammatory markers.
This study recruits 20-24 (total) female and male subjects in a blinded, randomized, crossover design consisting of two experimental diets (3 weeks each arm) based on a DASH-like diet (Dietary Approaches to Stop Hypertension diet) with % Energy (E%): 55 E% of carbohydrate, 15 E% of protein, and 30 E% of fat (9 E% saturated fatty acids (SFA), 15 E% of monounsaturated fatty acids (MUFA), and 6 E% of polyunsaturated fatty acids (PUFA)). One experimental arm contains milk fat and the other diet contains a control fat.
A washout period represents an average US diet (48 E% of carbohydrate, 15 E% of protein and 37 E% of fat, kcal (16 E% of SFA, 14 E% of MUFA, and 7 E% of PUFA) is used to establish a level of normalization of the fatty acid intake among the subjects and to standardize the subject's physiologic state before each experimental diet.
The two experimental diets are constructed to provide three servings of dairy in the form of either 1) regular whole (full-fat, 3.25%) yogurt or 2) fat-free yogurt supplemented with a control fat. The diets are identical in terms of menus, macro- and micronutrients, and fatty acid class composition (E%) with the exception of individual bioactive fatty acids, allowing for the comparison of the bioactive milk fatty acids to non-milk fatty acids.
At the end of each period (initial washout period and each experimental diet) a frequently sampled intravenous glucose tolerance test is performed, blood is taken for fasting lipids (including lipoprotein profile), serum phospholipid fatty acid profiles, and inflammatory markers, and stool is sampled to examine the fecal microbiota composition.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Examining the Effects of Consuming a Diet Comprising of Milk Fat on Metabolic Health Markers|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Milk fat
A 21-day low-fat (E%) experimental diet including milk fat with macronutrient and fatty acid class profiles differing only in type of fat and, thus, the proportion of single (bioactive) fatty acids.
Dietary Supplement: Milk Fat
Three daily servings of whole yogurt (3.25% fat).
Experimental: Control Fat
A 21-day low-fat experimental diet. Eucaloric diet to Arm #1 with macronutrient and fatty acid class profiles differing only in type of fat and, thus, the proportion of single fatty acids. A control fat is used to replace dairy fats.
Dietary Supplement: Control Fat
Three daily servings of fat-free yogurt supplemented with a control fat.
- Insulin sensitivity [ Time Frame: 3 weeks ]Determined via a frequently sampled intravenous glucose tolerance test (FSIVGTT). Serum samples are analyzed in-house (glucose: glucose oxidase method; insulin: ELISA) to be used in Bergman's minimal model analysis. The results will be used to estimate insulin sensitivity.
- Blood lipids [ Time Frame: 3 weeks ]Plasma samples analyzed by Nuclear magnetic resonance (NMR) spectroscopy and chemical lipid panel for blood lipids (triacylglycerols, cholesterol profile, including lipoprotein subclasses, lipoprotein particle sizes (Lp(a)),
- Inflammation markers. [ Time Frame: 3 weeks ]Plasma samples analysed using a high-sensitivity, magnetic, Luminex-based performance assay.
- Serum phospholipid analysis [ Time Frame: 3 weeks ]Serum phospholipid via SPS analyzed by gas chromatography/mass spectrometry (GC-FID).
- Bacterial microbiota [ Time Frame: 3 weeks ]Fecal samples collected for the analysis of intestinal bacterial composition using next-generation sequencing (Illumina Miseq V 3.1). Bacterial phyla, classes, orders, and families determined.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659748
|United States, Vermont|
|Clinical Research Center, University of Vermont Medical Center|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Jana Kraft, PhD||University of Vermont|
|Principal Investigator:||Craig L Kien, MD||UVM Medical Center|