Insulin SensitivityDMFMHMNCT02659748
Milk Fat Intake and Metabolic Health Markers
A study testing Milk Fat in people with Insulin Sensitivity and Type 2 Diabetes, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
This study investigates the effects of bioactive fatty acids in full fat dairy (whole yogurt), on insulin action, calorie needs, blood lipids, immune function, and body composition in normal and overweight male and female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Type 2 Diabetes
- What is being tested?
- Milk Fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health and not expecting major lifestyle changes while on study
- BMI between 18.5 and 29.9 kg/m2
- Willing to follow the study coordinator's and dietitian's instructions
Who cannot join
- Subject with any chronic disease, inflammatory disease and previous diagnosis of HIV or hepatitis C
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Examining the Effects of Consuming a Diet Comprising of Milk Fat on Metabolic Health Markers
This study investigates the effects of bioactive fatty acids in full fat dairy (whole yogurt), on insulin action, calorie needs, blood lipids, immune function, and body composition in normal and overweight male and female volunteers.
Read the detailed description
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.
- Conditions
- Insulin Sensitivity, Type 2 Diabetes
- Being tested
- Milk Fat, Control Fat
- Keywords
- Bioactive fatty acids, Insulin sensitivity, Diet, Milk fat, Lipid metabolism, Inflammation markers, Fecal microbiota composition
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk FatDietary supplement
Three daily servings of whole yogurt (3.25% fat).
Control FatDietary supplement
Three daily servings of fat-free yogurt supplemented with a control fat.
| Study group | Role | What they receive |
|---|---|---|
| Milk fat | Experimental | 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. Receives: Dietary Supplement: Milk Fat |
| Control Fat | Experimental | 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. Receives: Dietary Supplement: Control Fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
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.
Measured: 3 weeks
Secondary outcomes (4)
Blood lipids
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)),
Measured: 3 weeks
Inflammation markers.
Plasma samples analysed using a high-sensitivity, magnetic, Luminex-based performance assay.
Measured: 3 weeks
Serum phospholipid analysis
Serum phospholipid via SPS analyzed by gas chromatography/mass spectrometry (GC-FID).
Measured: 3 weeks
Bacterial microbiota
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Research Institute, University of Vermont
- Responsible party
- Principal investigator, Jana Kraft, University of Vermont
- Investigators
- Jana Kraft, PhD, Principal investigator, University of VermontCraig L Kien, MD, Principal investigator, UVM Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659748
- Sponsor's protocol ID
- CHRMS M14-011
- Other IDs
- 1195
- Acronym
- DMFMHM
- Status last verified
- Oct 2016
- First submitted
- 15 Jan 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Consuming a Diet Comprising of Milk Fat on Metabolic Health Markers
- ClinicalTrials.gov ID
- NCT02659748
- Acronym / sponsor ID
- DMFMHM / CHRMS M14-011
- Conditions
- Insulin Sensitivity, Type 2 Diabetes
- Keywords
- Bioactive fatty acids, Insulin sensitivity, Diet, Milk fat, Lipid metabolism, Inflammation markers, Fecal microbiota composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Collaborators
- Dairy Research Institute, University of Vermont
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effects of bioactive fatty acids in full fat dairy (whole yogurt), on insulin action, calorie needs, blood lipids, immune function, and body composition in normal and overweight male and female volunteers.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk fat | Experimental | Dietary Supplement: Milk FatA 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. |
| Control Fat | Experimental | Dietary Supplement: Control FatA 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general health and not expecting major lifestyle changes while on study
- BMI between 18.5 and 29.9 kg/m2
- Willing to follow the study coordinator's and dietitian's instructions
Key exclusion criteria (17 listed)
- Subject with any chronic disease, inflammatory disease and previous diagnosis of HIV or hepatitis C
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk FatThree daily servings of whole yogurt (3.25% fat). | Dietary supplement | Milk fat |
| Control FatThree daily servings of fat-free yogurt supplemented with a control fat. | Dietary supplement | Control Fat |
Primary outcome
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.
4 secondary outcomes
Blood lipids
Time frame: 3 weeks
Inflammation markers.
Time frame: 3 weeks
Serum phospholipid analysis
Time frame: 3 weeks
Bacterial microbiota
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: Yes
Related trials for Insulin Sensitivity
Active, not recruiting
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Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
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Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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Effects of Mango on Insulin Sensitivity in Prediabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana Kraft, PhD principal investigator
University of Vermont
Craig L Kien, MD principal investigator
UVM Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk Fat in people with Insulin Sensitivity and Type 2 Diabetes, run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.