Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
21 participants
INTERVENTIONAL
2014-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Milk Fat
Three daily servings of whole yogurt (3.25% fat).
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.
Control Fat
Three daily servings of fat-free yogurt supplemented with a control fat.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Milk Fat
Three daily servings of whole yogurt (3.25% fat).
Control Fat
Three daily servings of fat-free yogurt supplemented with a control fat.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI between 18.5 and 29.9 kg/m2
* Willing to follow the study coordinator's and dietitian's instructions
Exclusion Criteria
* Subjects with diabetes (type 1 or 2)
* Subjects with insulin resistance
* Subjects who manifest metabolic syndrome based on aggregate clinical signs
* Intolerance to dairy foods
* Use of prescription medication (except oral contraceptives)
* On medically prescribed diets or following a diet
* Taking supplements that could obscure our ability to detect diet effects
* Frequent use of over-the-counter medication
* Habitual use of tobacco or controlled substances such as cannabis
* Low-density lipoprotein cholesterol (LDL-C) or triacylglycerol (TAG) concentrations \<5th or \>95th percentile for age
* Participation on regular basis in competitive sports or habitual aerobic exercise training, which we will arbitrarily define as consisting of \> 3 bouts/wk of aerobic exercise (unable to speak comfortably) for more than 20 min
* Women who are pregnant or lactating or planning to get pregnant
* Allergies or significant food preferences or restrictions that would interfere with diet adherence
* Lifestyle or schedule incompatible with the study protocol
* Psychiatric or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol
* Heart condition
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dairy Research Institute
OTHER
University of Vermont
OTHER
University of Vermont Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jana Kraft
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jana Kraft, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Craig L Kien, MD
Role: PRINCIPAL_INVESTIGATOR
UVM Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Center, University of Vermont Medical Center
Burlington, Vermont, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1195
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CHRMS M14-011
Identifier Type: -
Identifier Source: org_study_id