Pre-DiabetesNCT03577119
Full-fat Yogurt and Glucose Tolerance
A study testing Full-fat yogurt and Non-fat yogurt in people with Pre-Diabetes, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
This study determines if substituting full-fat yogurt (i.e., whole, 3.25% fat) for non-fat yogurt in the diet can reduce the risk of type 2 diabetes and inflammation in association with changes in the composition of the gastrointestinal bacteria prediabetic male and female volunteers. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-Diabetes
- What is being tested?
- Full-fat yogurt and Non-fat yogurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 30 Jun 2022
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women and not expecting major lifestyle changes while on study
- Age 45-75
- Overweight and obesity (BMI 20-45 kg/m2)
- Stable body weight for the last 6 months (no more than a +/- 5% change)
- Diagnosis of prediabetes, defined as either impaired fasting glucose (fasting glucose: 100-125 mg/dL), impaired glucose tolerance (blood glucose levels of between: 140-199 mg/dL 2-hr post 75-g oral glucose tolerance test), and/or a hemoglobin A1C (HbA1C) level ranging from 5.7% to 7.0% (if HbA1C above 6.4%, monotherapy of Metformin)
- Women: Post-Menopausal: no menses previous 12 mos.; Follicular Stimulating Hormone (FSH) > 20 mIU/mL
Show all 12Show fewer
- Consuming at least 25% of calories from fat (screening will be based an online fat screener:
- http://nutritionquest.com/wellness/free-assessment-tools-for-individuals/fat-intake-screener/
- Normal cognition
- Read and understand English
- Have a telephone
- Willing to follow the study coordinator's/manager's and dietitian's instructions
Who cannot join
- Fasting blood glucose ≥126 mg/dL, HbA1C ≥7.0% without monotheraoy of Metformin
- Subject with any chronic disease, inflammatory disease (e.g., asthma, rheumatoid arthritis, Crohn's disease or inflammatory bowel disease) and previous diagnosis of HIV or hepatitis C
- Pregnant or breastfeeding women or women on hormone replacement therapy (for previous 3 months)
- Intolerance to dairy foods (i.e., lactose intolerance or protein allergy), food allergies, or significant food preferences, dietary restrictions (vegetarian, vegan lifestyle), or food aversions that would interfere with diet adherence
- History of a diagnosed eating disorder
- Known/diagnosed gastrointestinal problems (e.g., inflammatory bowel disease, irritable bowel syndrome, etc.)
Show all 16Show fewer
- Antibiotics use during the past 6 months
- Habitual use of tobacco or controlled substances, and dietary supplements during the study and 1 month prior to the study
- On medically prescribed diets or following a diet (e.g., to lose weight) or use of obesity or weight-loss treatments such as dietary interventions or pharmacotherapy
- Chronic anti-inflammatory medications, or frequent use (>25% of the time) of over-the-counter medication including laxatives and antacids (subjects with occasional use of allergy or cold medicine, NSAIDS, acetaminophen, or aspirin will be recruited, but these drugs will not be permitted during the study, except for acute administration up to 3 days prior to the outcome variables).
- Waist circumference >40 inches in men and >35 inches in women
- Current diagnosis of uncontrolled hypertension (systolic BP: >160mmHg, diastolic BP: >95mmHg), (may receive treatment for hypertension as long as 1) on a stable regime for the previous 6 wk, and 2) no anticipated change while on the study)
- Untreated hyperlipidemia [may receive treatment for hyperlipidemia (statins) as long as 1) on a stable regime for the previous 6 wk, and 2) no anticipated change while on the study)
- Participation on regular basis in competitive sports or habitual aerobic exercise training, which we will arbitrarily define a consisting of > 3 bouts/wk of aerobic exercise (unable to speak comfortably) for more than 20 min
- 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
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
This study determines if substituting full-fat yogurt (i.e., whole, 3.25% fat) for non-fat yogurt in the diet can reduce the risk of type 2 diabetes and inflammation in association with changes in the composition of the gastrointestinal bacteria prediabetic male and female volunteers. The central hypothesis is that dairy fat impacts whole body glucose handling and insulin sensitivity as well as inflammation both directly, and indirectly via influencing the gut microbiota composition.
Read the detailed description
The overall objective of this study is to determine if substituting full-fat yogurt (i.e., whole, 3.25% fat) for non-fat yogurt in the diet can i) improve whole body glucose handling and insulin sensitivity, ii) modulate systemic inflammation, and iii) induce putatively beneficial changes in the composition of the colonic microbiota in prediabetic men and women. By comparing a diet containing non-fat yogurt with a diet comprising of full-fat yogurt, the investigators will address the following specific hypotheses and aims:
Hypothesis 1: Dietary intake of full-fat yogurt will improve fasting and postprandial markers of glucose homeostasis, insulin sensitivity, and pancreatic cell function. Aim 1: Evaluating the diet-induced changes in blood glucose and endogenous insulin secretion. This will be assessed through a mixed meal tolerance test and oral glucose tolerance test.
Hypothesis 2: Dietary intake of full-fat yogurt will relatively reduce systemic inflammation. Aim 2: Examine diet-induced changes in inflammatory tone. This will be assessed through measurements of circulating (plasma) pro- and anti-inflammatory cytokines, cytokine production assays from in vitro-stimulated peripheral blood mononuclear cells, and plasma stimulated cytokine production in immortalized human cell lines.
Hypothesis 3: A diet containing full-fat yogurt will alter the colonic bacteria structure (e.g. decrease the Firmicutes/Bacteroidetes ratio). Aim 3: Characterize diet-induced alterations in colonic bacteria structure (composition and density) via next-generation sequencing and real-time Polymerase Chain Reaction Assays (PCR).
This study recruits 32 pre-diabetic female and male volunteers (50:50) aged 45-75 using a double-blinded, randomized crossover design to compare two experimental diets, 1) a low-fat diet containing fat-free yogurt (total fat: 28% energy), and 2) a higher fat diet consisting of whole 3.25% fat yogurt (total fat: 38% energy). Fat in the whole yogurt accounts entirely for the arithmetic difference in fat of 10% energy between the two diets. The study will consist of two 21-day experimental diet periods preceded by a 7-day control diet. The total length of study will be 8 weeks. The diet during the control diet periods will be an average U.S. diet to establish a normalized fatty acid intake among the subjects and to standardize the subject's physiologic state before each experimental diet. At the end of the first control period ("run-in") and at the end of each of the experimental diets, a mixed meal tolerance test and an oral glucose test will be performed to assess diet-induced changes in whole-body glucose handling and insulin sensitivity. In addition, blood and stool samples will be collected to examine diet-induced alterations in inflammatory tone and gastrointestinal microflora.
- Conditions
- Pre-Diabetes
- Being tested
- Full-fat yogurt, Non-fat yogurt
- Keywords
- Prediabetes, Glucose Tolerance, Bioactive fatty acids, Insulin sensitivity, Diet, Milk fat, Lipid metabolism, Inflammation markers, Fecal microbiota composition, Dairy
- Medical subject headings
- Glucose Intolerance, Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-fat yogurtDietary supplement
Controlled diet that includes three daily servings of whole (3.25% fat) yogurt.
Non-fat yogurtDietary supplement
Controlled diet that includes three daily servings of fat-free yogurt.
| Study group | Role | What they receive |
|---|---|---|
| Full-fat yogurt | Experimental | Participants will receive a 21-day controlled diet that includes three daily servings of whole (3.25% fat) yogurt (38% of energy from fat, 44% of energy from carbohydrates, and 18% of energy from protein). Receives: Dietary Supplement: Full-fat yogurt |
| Non-fat yogurt (Control) | Experimental | Participants will receive a 21-day controlled diet that includes three daily servings of fat-free yogurt (28% of energy from fat, 54% of energy from carbohydrates, and 18% of energy from protein). Receives: Dietary Supplement: Non-fat yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin sensitivity and β-cell function: MMTT
Evaluated through mixed meal tolerance test (MMTT) prior to and post experimental diets. Tests will be quantified using the area under the curve (AUC) of the temporal changes in blood glucose, insulin, C-peptide, and incretins (GLP-1 and GIP) using fasting and serial postprandial blood samples. All measurements will be reported as mol/L.
Measured: Baseline, 4 weeks, and 8 weeks
Changes in insulin sensitivity and β-cell function: OGTT
Evaluated through oral glucose tolerance test (OGTT) prior to and post experimental diets. Tests will be quantified using the area under the curve (AUC) of the temporal changes in blood glucose, insulin, C-peptide, and incretins (GLP-1 and GIP) using fasting and serial postprandial blood samples. All measurements will be reported as mol/L.
Measured: Baseline, 4 weeks, and 8 weeks
Secondary outcomes (3)
Changes in inflammatory markers
Evaluated through measurements of circulating (plasma) pro- and anti-inflammatory cytokines, cytokine production assays from in vitro-stimulated peripheral blood mononuclear cells, and plasma stimulated cytokine production in immortalized human cell lines prior to and post experimental diets. Inflammatory markers that will be measured are: interleukins 1beta, 6, 8, and 10 (IL-1beta, IL-6, IL-8, and IL-10), and tumor necrosis factor alpha (TNFalpha). All measurements will be reported as pg/mL.
Measured: Baseline, 4 weeks, and 8 weeks
Changes to Colonic microbiota structure: density
Evaluated through analysis of colonic bacteria structure (composition and density) of specific colonic microbiota prior to and post experimental diets. Density of colonic bacteria will be measured in log copies/ug feces.
Measured: Baseline, 4 weeks, and 8 weeks
Changes to Colonic microbiota structure: relative abundance
Evaluated through analysis of colonic bacteria structure (composition and density) of specific colonic microbiota prior to and post experimental diets. Relative abundance of Taxa of colonic bacteria will be reported as a percentage (%).
Measured: Baseline, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (71)Papers the sponsor has linked to this study.
- Other trials for Pre-DiabetesStudies 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
- Model description
- This study will employ a controlled, randomized, double-blinded crossover trial comparing two diets.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Principal investigator, Jana Kraft, University of Vermont Medical Center
- Investigators
- Jana Kraft, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577119
- Sponsor's protocol ID
- 18-0295
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2018
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmberg S, Thelin A. High dairy fat intake related to less central obesity: a male cohort study with 12 years' follow-up. Scand J Prim Health Care. 2013 Jun;31(2):89-94. doi: 10.3109/02813432.2012.757070. Epub 2013 Jan 15.
PubMed 23320900Kratz M, Baars T, Guyenet S. The relationship between high-fat dairy consumption and obesity, cardiovascular, and metabolic disease. Eur J Nutr. 2013 Feb;52(1):1-24. doi: 10.1007/s00394-012-0418-1. Epub 2012 Jul 19.
PubMed 22810464Scharf RJ, Demmer RT, DeBoer MD. Longitudinal evaluation of milk type consumed and weight status in preschoolers. Arch Dis Child. 2013 May;98(5):335-40. doi: 10.1136/archdischild-2012-302941. Epub 2013 Mar 18.
PubMed 23508869Li, S., Field, A., Rimm, E. & Flint, A. Dairy consumption with onset of overweight and obesity among U.S. adolescents. FASEB J 28, 370.7 (2014).
Kratz M, Marcovina S, Nelson JE, Yeh MM, Kowdley KV, Callahan HS, Song X, Di C, Utzschneider KM. Dairy fat intake is associated with glucose tolerance, hepatic and systemic insulin sensitivity, and liver fat but not beta-cell function in humans. Am J Clin Nutr. 2014 Jun;99(6):1385-96. doi: 10.3945/ajcn.113.075457. Epub 2014 Apr 16.
PubMed 24740208Yakoob MY, Shi P, Willett WC, Rexrode KM, Campos H, Orav EJ, Hu FB, Mozaffarian D. Circulating Biomarkers of Dairy Fat and Risk of Incident Diabetes Mellitus Among Men and Women in the United States in Two Large Prospective Cohorts. Circulation. 2016 Apr 26;133(17):1645-54. doi: 10.1161/CIRCULATIONAHA.115.018410. Epub 2016 Mar 22.
PubMed 27006479Ericson U, Hellstrand S, Brunkwall L, Schulz CA, Sonestedt E, Wallstrom P, Gullberg B, Wirfalt E, Orho-Melander M. Food sources of fat may clarify the inconsistent role of dietary fat intake for incidence of type 2 diabetes. Am J Clin Nutr. 2015 May;101(5):1065-80. doi: 10.3945/ajcn.114.103010. Epub 2015 Apr 1.
PubMed 25832335Gijsbers L, Ding EL, Malik VS, de Goede J, Geleijnse JM, Soedamah-Muthu SS. Consumption of dairy foods and diabetes incidence: a dose-response meta-analysis of observational studies. Am J Clin Nutr. 2016 Apr;103(4):1111-24. doi: 10.3945/ajcn.115.123216. Epub 2016 Feb 24.
PubMed 26912494Jensen RG. The composition of bovine milk lipids: January 1995 to December 2000. J Dairy Sci. 2002 Feb;85(2):295-350. doi: 10.3168/jds.S0022-0302(02)74079-4.
PubMed 11913692Roy CC, Kien CL, Bouthillier L, Levy E. Short-chain fatty acids: ready for prime time? Nutr Clin Pract. 2006 Aug;21(4):351-66. doi: 10.1177/0115426506021004351.
PubMed 16870803Barber MC, Clegg RA, Travers MT, Vernon RG. Lipid metabolism in the lactating mammary gland. Biochim Biophys Acta. 1997 Aug 16;1347(2-3):101-26. doi: 10.1016/s0005-2760(97)00079-9. No abstract available.
PubMed 9295156Keeney, M. K., Katz, I. & Allison, M.J. On the probable origin of some milk fat acids in rumen microbial lipids. J Am Oil Chem Soc 39, 198-201 (1962).
Jenkins B, West JA, Koulman A. A review of odd-chain fatty acid metabolism and the role of pentadecanoic Acid (c15:0) and heptadecanoic Acid (c17:0) in health and disease. Molecules. 2015 Jan 30;20(2):2425-44. doi: 10.3390/molecules20022425.
PubMed 25647578Palmquist DL, Lock AL, Shingfield KJ, Bauman DE. Biosynthesis of conjugated linoleic acid in ruminants and humans. Adv Food Nutr Res. 2005;50:179-217. doi: 10.1016/S1043-4526(05)50006-8. No abstract available.
PubMed 16263431Shingfield KJ, Chilliard Y, Toivonen V, Kairenius P, Givens DI. Trans fatty acids and bioactive lipids in ruminant milk. Adv Exp Med Biol. 2008;606:3-65. doi: 10.1007/978-0-387-74087-4_1. No abstract available.
PubMed 18183924
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-fat Yogurt and Glucose Tolerance
- ClinicalTrials.gov ID
- NCT03577119
- Acronym / sponsor ID
- 18-0295
- Conditions
- Pre-Diabetes
- Keywords
- Prediabetes, Glucose Tolerance, Bioactive fatty acids, Insulin sensitivity, Diet, Milk fat, Lipid metabolism, Inflammation markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 Jul 2018 (actual)
- 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 determines if substituting full-fat yogurt (i.e., whole, 3.25% fat) for non-fat yogurt in the diet can reduce the risk of type 2 diabetes and inflammation in association with changes in the composition of the gastrointestinal bacteria prediabetic male and female volunteers. The central hypothesis is that dairy fat impacts whole body glucose handling and insulin sensitivity as well as inflammation both directly, and indirectly via influencing the gut microbiota composition.
Detailed description
The overall objective of this study is to determine if substituting full-fat yogurt (i.e., whole, 3.25% fat) for non-fat yogurt in the diet can i) improve whole body glucose handling and insulin sensitivity, ii) modulate systemic inflammation, and iii) induce putatively beneficial changes in the composition of the colonic microbiota in prediabetic men and women. By comparing a diet containing non-fat yogurt with a diet comprising of full-fat yogurt, the investigators will address the following specific hypotheses and aims:
Hypothesis 1: Dietary intake of full-fat yogurt will improve fasting and postprandial markers of glucose homeostasis, insulin sensitivity, and pancreatic cell function. Aim 1: Evaluating the diet-induced changes in blood glucose and endogenous insulin secretion. This will be assessed through a mixed meal tolerance test and oral glucose tolerance test.
Hypothesis 2: Dietary intake of full-fat yogurt will relatively reduce systemic inflammation. Aim 2: Examine diet-induced changes in inflammatory tone. This will be assessed through measurements of circulating (plasma) pro- and anti-inflammatory cytokines, cytokine production assays from in vitro-stimulated peripheral blood mononuclear cells, and plasma stimulated cytokine production in immortalized human cell lines.
Hypothesis 3: A diet containing full-fat yogurt will alter the colonic bacteria structure (e.g. decrease the Firmicutes/Bacteroidetes ratio). Aim 3: Characterize diet-induced alterations in colonic bacteria structure (composition and density) via next-generation sequencing and real-time Polymerase Chain Reaction Assays (PCR).
This study recruits 32 pre-diabetic female and male volunteers (50:50) aged 45-75 using a double-blinded, randomized crossover design to compare two experimental diets, 1) a low-fat diet containing fat-free yogurt (total fat: 28% energy), and 2) a higher fat diet consisting of whole 3.25% fat yogurt (total fat: 38% energy). Fat in the whole yogurt accounts entirely for the arithmetic difference in fat of 10% energy between the two diets. The study will consist of two 21-day experimental diet periods preceded by a 7-day control diet. The total length of study will be 8 weeks. The diet during the control diet periods will be an average U.S. diet to establish a normalized fatty acid intake among the subjects and to standardize the subject's physiologic state before each experimental diet. At the end of the first control period ("run-in") and at the end of each of the experimental diets, a mixed meal tolerance test and an oral glucose test will be performed to assess diet-induced changes in whole-body glucose handling and insulin sensitivity. In addition, blood and stool samples will be collected to examine diet-induced alterations in inflammatory tone and gastrointestinal microflora.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will employ a controlled, randomized, double-blinded crossover trial comparing two diets.
| Arm | Type | Receives |
|---|---|---|
| Full-fat yogurt | Experimental | Dietary Supplement: Full-fat yogurtParticipants will receive a 21-day controlled diet that includes three daily servings of whole (3.25% fat) yogurt (38% of energy from fat, 44% of energy from carbohydrates, and 18% of energy from protein). |
| Non-fat yogurt (Control) | Experimental | Dietary Supplement: Non-fat yogurtParticipants will receive a 21-day controlled diet that includes three daily servings of fat-free yogurt (28% of energy from fat, 54% of energy from carbohydrates, and 18% of energy from protein). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women and not expecting major lifestyle changes while on study
- Age 45-75
- Overweight and obesity (BMI 20-45 kg/m2)
- Stable body weight for the last 6 months (no more than a +/- 5% change)
- Diagnosis of prediabetes, defined as either impaired fasting glucose (fasting glucose: 100-125 mg/dL), impaired glucose tolerance (blood glucose levels of between: 140-199 mg/dL 2-hr post 75-g oral glucose tolerance test), and/or a hemoglobin A1C (HbA1C) level ranging from 5.7% to 7.0% (if HbA1C above 6.4%, monotherapy of Metformin)
Key exclusion criteria (16 listed)
- Fasting blood glucose ≥126 mg/dL, HbA1C ≥7.0% without monotheraoy of Metformin
- Subject with any chronic disease, inflammatory disease (e.g., asthma, rheumatoid arthritis, Crohn's disease or inflammatory bowel disease) and previous diagnosis of HIV or hepatitis C
- Pregnant or breastfeeding women or women on hormone replacement therapy (for previous 3 months)
- Intolerance to dairy foods (i.e., lactose intolerance or protein allergy), food allergies, or significant food preferences, dietary restrictions (vegetarian, vegan lifestyle), or food aversions that would interfere with diet adherence
- History of a diagnosed eating disorder
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 |
|---|---|---|
| Full-fat yogurtControlled diet that includes three daily servings of whole (3.25% fat) yogurt. | Dietary supplement | Full-fat yogurt |
| Non-fat yogurtControlled diet that includes three daily servings of fat-free yogurt. | Dietary supplement | Non-fat yogurt (Control) |
Primary outcome
Changes in insulin sensitivity and β-cell function: MMTT
Time frame: Baseline, 4 weeks, and 8 weeks
Evaluated through mixed meal tolerance test (MMTT) prior to and post experimental diets. Tests will be quantified using the area under the curve (AUC) of the temporal changes in blood glucose, insulin, C-peptide, and incretins (GLP-1 and GIP) using fasting and serial postprandial blood samples. All measurements will be reported as mol/L.
Changes in insulin sensitivity and β-cell function: OGTT
Time frame: Baseline, 4 weeks, and 8 weeks
Evaluated through oral glucose tolerance test (OGTT) prior to and post experimental diets. Tests will be quantified using the area under the curve (AUC) of the temporal changes in blood glucose, insulin, C-peptide, and incretins (GLP-1 and GIP) using fasting and serial postprandial blood samples. All measurements will be reported as mol/L.
3 secondary outcomes
Changes in inflammatory markers
Time frame: Baseline, 4 weeks, and 8 weeks
Changes to Colonic microbiota structure: density
Time frame: Baseline, 4 weeks, and 8 weeks
Changes to Colonic microbiota structure: relative abundance
Time frame: Baseline, 4 weeks, and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 23320900Holmberg S, Thelin A. High dairy fat intake related to less central obesity: a male cohort study with 12 years' follow-up. Scand J Prim Health Care. 2013 Jun;31(2):89-94. doi: 10.3109/02813432.2012.757070. Epub 2013 Jan 15.
- Background: PubMed 22810464Kratz M, Baars T, Guyenet S. The relationship between high-fat dairy consumption and obesity, cardiovascular, and metabolic disease. Eur J Nutr. 2013 Feb;52(1):1-24. doi: 10.1007/s00394-012-0418-1. Epub 2012 Jul 19.
- Background: PubMed 23508869Scharf RJ, Demmer RT, DeBoer MD. Longitudinal evaluation of milk type consumed and weight status in preschoolers. Arch Dis Child. 2013 May;98(5):335-40. doi: 10.1136/archdischild-2012-302941. Epub 2013 Mar 18.
- BackgroundLi, S., Field, A., Rimm, E. & Flint, A. Dairy consumption with onset of overweight and obesity among U.S. adolescents. FASEB J 28, 370.7 (2014).
- Background: PubMed 24740208Kratz M, Marcovina S, Nelson JE, Yeh MM, Kowdley KV, Callahan HS, Song X, Di C, Utzschneider KM. Dairy fat intake is associated with glucose tolerance, hepatic and systemic insulin sensitivity, and liver fat but not beta-cell function in humans. Am J Clin Nutr. 2014 Jun;99(6):1385-96. doi: 10.3945/ajcn.113.075457. Epub 2014 Apr 16.
- Background: PubMed 27006479Yakoob MY, Shi P, Willett WC, Rexrode KM, Campos H, Orav EJ, Hu FB, Mozaffarian D. Circulating Biomarkers of Dairy Fat and Risk of Incident Diabetes Mellitus Among Men and Women in the United States in Two Large Prospective Cohorts. Circulation. 2016 Apr 26;133(17):1645-54. doi: 10.1161/CIRCULATIONAHA.115.018410. Epub 2016 Mar 22.
- Background: PubMed 25832335Ericson U, Hellstrand S, Brunkwall L, Schulz CA, Sonestedt E, Wallstrom P, Gullberg B, Wirfalt E, Orho-Melander M. Food sources of fat may clarify the inconsistent role of dietary fat intake for incidence of type 2 diabetes. Am J Clin Nutr. 2015 May;101(5):1065-80. doi: 10.3945/ajcn.114.103010. Epub 2015 Apr 1.
- Background: PubMed 26912494Gijsbers L, Ding EL, Malik VS, de Goede J, Geleijnse JM, Soedamah-Muthu SS. Consumption of dairy foods and diabetes incidence: a dose-response meta-analysis of observational studies. Am J Clin Nutr. 2016 Apr;103(4):1111-24. doi: 10.3945/ajcn.115.123216. Epub 2016 Feb 24.
- Background: PubMed 11913692Jensen RG. The composition of bovine milk lipids: January 1995 to December 2000. J Dairy Sci. 2002 Feb;85(2):295-350. doi: 10.3168/jds.S0022-0302(02)74079-4.
- Background: PubMed 16870803Roy CC, Kien CL, Bouthillier L, Levy E. Short-chain fatty acids: ready for prime time? Nutr Clin Pract. 2006 Aug;21(4):351-66. doi: 10.1177/0115426506021004351.
- Background: PubMed 9295156Barber MC, Clegg RA, Travers MT, Vernon RG. Lipid metabolism in the lactating mammary gland. Biochim Biophys Acta. 1997 Aug 16;1347(2-3):101-26. doi: 10.1016/s0005-2760(97)00079-9. No abstract available.
- BackgroundKeeney, M. K., Katz, I. & Allison, M.J. On the probable origin of some milk fat acids in rumen microbial lipids. J Am Oil Chem Soc 39, 198-201 (1962).
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-fat yogurt and Non-fat yogurt in people with Pre-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 12 inclusion and 16 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: finished, as of the sponsor's last update on 30 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in insulin sensitivity and β-cell function: MMTT (time frame: Baseline, 4 weeks, and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577119, which also lists 71 linked publications.
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 30 Jun 2022.