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DiabetesNCT01936935

Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function

A study testing Low-fat dairy and Sugar-sweetened beverages in people with Diabetes, run by Provident Clinical Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this trial is to evaluate the effects of dairy product consumption on insulin sensitivity and pancreatic β-cell function in men and women at risk for the development of type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet sodas and fruit juice cocktails). Read more about this study

Who is it for?
Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
Low-fat dairy and Sugar-sweetened beverages
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteUnited States
Study dates
Sep 2012to Sep 2013
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 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • subject is male or female, 18-74 yrs of age, inclusive
  • subject reports habitual consumption of ≥2 servings/d of high-sugar beverages (e.g., non-diet soda, fruit juice cocktails)
  • subject has waist circumference ≥33.0 inches for women and ≥36.0 inches for men
  • subject is at risk for development of type 2 diabetes mellitus (T2DM), based on 1 or more of the following: fasting glucose 100-125 mg/dL; glycosylated hemoglobin 5.7-6.4%, or ≥20% risk of developing diabetes in the next 7.5 yrs based on the San Antonio Heart Study prediction equation
  • subject has a score of 7-10 on the Vein Access Scale at screening
  • subject is normally active and judged to be in good health on the basis of medical history, physical examination and routine lab tests
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  • if female, subject is willing to schedule treatment visits during the follicular phase of the menstrual cycle, defined as days 1-14, where day 1 is 1st day of menses
  • subject has a menstrual cycle duration ranging in length form 24-36 d (if premenopausal)
  • subject is willing to maintain a stable body weight and follow his/her habitual diet and exercise pattern, except for inclusion of study product, throughout the trial
  • subject is willing to maintain his or her habitual intake of coffee, tea, and alcoholic beverages throughout the trial
  • subject agrees to limit intake of non-study related dairy products to ≤1 serving per day during each treatment period
  • subject is ambulatory and willing to refrain from vigorous physical activity and consumption of alcoholic beverages 24 h prior to each test day
  • subject has no plans to change smoking habits during the study period
  • subject is willing to abstain from tobacco use 1 h prior to and during visits on LMTT test days
  • subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine lab test results

Who cannot join

  • subject has abnormal lab test results of clinical importance, including, but not limited to, TG ≥400 mg/dL, fasting creatinine ≥1.5 mg/dL, alanine aminotransferase or aspartate aminotransferase ≥1.5 times the upper limit of normal at screening
  • subject has a body mass index ≥45.0 kg/m2
  • subject has fasting blood glucose ≥126 mg/dL at screening or known diabetes mellitus (type 1 or T2DM)
  • subject has a habitual intake of ≥4 servings/d of dairy food and beverages
  • subject has known allergy or sensitivity to study product or any ingredients of study product. Subjects with lactose intolerance will be allowed to use products such as Lactaid dietary supplements
  • subject has a history of coronary heart disease, congestive heart failure, or serious ventricular dysrhythmias (ventricular tachycardia or fibrillation)
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  • subject has a change in body weight of >4.5 kg within 4 weeks of screening
  • subject uses medications known to influence carbohydrate metabolism
  • subject has recent use of antibiotics
  • subject has an active infection
  • subject has unstable use of anti-hypertensive medications, thyroid hormone replacement, or lipid-altering drugs within 4 weeks of screening
  • subject has unstable use of lipid-altering foods or dietary supplements within 4 weeks of screening
  • subject uses niacin at doses >200 mg/d within 4 weeks of screening
  • subject has history of extreme dietary habits, e.g., Atkins, high protein
  • subject has a history or presence of clinically important endocrine, cardiac, renal, hepatic, pulmonary, biliary, pancreatic, gastrointestinal, or neurologic disorders that could interfere with interpretation of study results
  • subject has history of dysphagia, swallowing disorders, or intestinal motility disorders
  • subject has history of cancer
  • subject has uncontrolled hypertension at screening (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Provident Clinical Research (now Biofortis)

    Addison, Illinois, 60101

Other trials in United States

About this study

Official title: A Randomized, Controlled, Crossover Trial to Assess the Effects of Dairy Intake on Insulin Sensitivity and β-Cell Function in Men and Women at Risk for Diabetes Who Are Habitual Consumers of High Sugar Beverages

The aim of this trial is to evaluate the effects of dairy product consumption on insulin sensitivity and pancreatic β-cell function in men and women at risk for the development of type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet sodas and fruit juice cocktails).

Conditions
Diabetes
Being tested
Low-fat dairy, Sugar-sweetened beverages
Keywords
Insulin sensitivity
Medical subject headings
Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-fat dairyOther

    2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt

  • Sugar-sweetened beveragesOther

    2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding

Study groups in NCT01936935
Study groupRoleWhat they receive
Low-fat dairyExperimental3 servings/d of low-fat dairy
Receives: Other: Low-fat dairy
Sugar-sweetened beveragesPlacebo comparator3 servings/d of sugar-sweetened foods
Receives: Other: Sugar-sweetened beverages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Matsuda Insulin Sensitivity Index (MISI)

    MISI calculated from glucose and insulin data obtained during a liquid meal tolerance test (LMTT). MISI = 10,000 divided by the square root of the quantity of fasting glucose x fasting insulin x mean post-load glucose from samples collected at 30, 60, 90 and 120 min after the start of the liquid meal x mean post-load insulin from samples collected at 30, 60, 90 and 120 min after the start of the liquid meal

    Measured: 6 weeks

Secondary outcomes (18)

  1. Waist circumference

    Measured using a non-stretch anthropometric tape

    Measured: 6 weeks

  2. Blood pressure

    Standardized vital signs measurements will include resting blood pressure and pulse measured using an automated blood pressure measurement device.

    Measured: 6 weeks

  3. Fasting and 2-hr LMTT insulin and glucose concentrations

    During the LMTT subjects consume a liquid meal load (two-8 oz servings of Ensure®, Ross Products Division, Abbott Laboratories, Columbus, Ohio), and blood samples will be obtained at t = -10, 30, 60, 90, and 120 min ± 5 min where t = 0 min is the start of meal consumption. Serum insulin and plasma glucose concentrations will be measured in fasting (-10 min) and 2 hr (120 min) samples.

    Measured: 6 weeks

  4. Homeostasis model assessment of insulin resistance (HOMA-IR)

    HOMA-IR = the quantity of fasting glucose in mg/dL x fasting insulin in microunits/mL divided by 405

    Measured: 6 weeks

  5. Homeostasis model assessment of beta-cell function (HOMA%B)

    HOMA%B = 360 x fasting insulin in microunits/mL divided by fasting glucose in mg/dL minus 63

    Measured: 6 weeks

  6. Glucose total area under the curve (AUC) from 0-120 min

    Glucose total AUC 0-120 min will be calculated using the trapezoidal rule on glucose concentrations in blood samples collected at -10, 30, 60, 90, and 120 min where 0 min is the start of the liquid meal consumption in the LMTT.

    Measured: 6 weeks

  7. Insulin total AUC 0-120 min

    Insulin total AUC 0-120 min will be calculated using the trapezoidal rule on insulin concentrations in blood samples collected at -10, 30, 60, 90, and 120 min where 0 min is the start of the liquid meal consumption in the LMTT.

    Measured: 6 weeks

  8. 30 min Δ insulin/Δ glucose

    Change in insulin from baseline to 30 min of the LMTT will be divided by the change in glucose from baseline to 30 min of the LMTT

    Measured: 6 weeks

  9. AUC insulin/AUC glucose

    AUC for insulin divided by the AUC for glucose

    Measured: 6 weeks

  10. Disposition Index

    Disposition index = MISI x the quantity of AUC for insulin divided by the AUC for glucose

    Measured: 6 weeks

  11. Fasting plasma total cholesterol (total-C)

    Measured: 6 weeks

  12. Fasting plasma low-density lipoprotein cholesterol (LDL-C)

    Calculated as LDL-C = total-C minus HDL-C minus the quantity of triglycerides (TG) divided by 5

    Measured: 6 weeks

  13. Fasting plasma high-density lipoprotein cholesterol (HDL-C)

    Measured: 6 weeks

  14. Fasting plasma total-C/HDL-C

    Calculated as total-C concentration divided by HDL-C concentration

    Measured: 6 weeks

  15. Fasting plasma non-HDL-C

    Calculated as non-HDL-C = total-C minus HDL-C

    Measured: 6 weeks

  16. Fasting plasma TG

    Measured: 6 weeks

  17. Serum 25-hydroxy vitamin D [25(OH)D]

    Measured: 6 weeks

  18. Plasma high-sensitivity C-reactive protein (hs-CRP)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01936935
Sponsor's protocol ID
PRV-1222
Status last verified
Sep 2013
First submitted
3 Sep 2013
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
No

Publications

  • Maki KC, Nieman KM, Schild AL, Kaden VN, Lawless AL, Kelley KM, Rains TM. Sugar-sweetened product consumption alters glucose homeostasis compared with dairy product consumption in men and women at risk of type 2 diabetes mellitus. J Nutr. 2015 Mar;145(3):459-66. doi: 10.3945/jn.114.204503. Epub 2015 Jan 7.

    PubMed 25733460

Questions about this trial

What is this clinical trial studying?

A study testing Low-fat dairy and Sugar-sweetened beverages in people with Diabetes, run by Provident Clinical Research 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 15 inclusion and 18 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 4 Dec 2023. 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. Some participants in this study may receive a placebo. 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?

Matsuda Insulin Sensitivity Index (MISI) (time frame: 6 weeks). 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 NCT01936935, which also lists 1 linked publication.

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 4 Dec 2023.

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