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AzTrials

Pre-diabetesNCT02934425

Effects of Lean Pork, High Protein Breakfast on Satiety and Metabolic Health in Pre-diabetes

A study testing Refined carbohydrate-rich breakfast and High pork protein breakfast in people with Pre-diabetes, run by Midwest Center for Metabolic and Cardiovascular 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 goal of this study is to assess the effects of consumption of a lean pork-containing, high-protein breakfast versus a refined carbohydrate-rich breakfast on satiety and cardiometabolic parameters in overweight or obese adults with pre-diabetes. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Pre-diabetes
What is being tested?
Refined carbohydrate-rich breakfast and High pork protein breakfast
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteUnited States
Study dates
Aug 2016to Feb 2017
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body mass index 25.0-39.9 kg/m2
  • At least 1 of the following: a) capillary glycated hemoglobin 5.7-6.4%, b) fasting capillary glucose 100-125 mg/dL, or c) capillary glycated hemoglobin <5.7% and borderline fasting capillary glucose level 95-99 mg/dL and a subsequent fasting venous plasma glucose 100-125 mg/dL
  • Self-identified "regular breakfast consumer" and willing to eat study foods as a breakfast meal
  • Access to freezer and a food re-heating appliance
  • Judged to be in good health on basis of medical history

Who cannot join

  • Fasting laboratory test results of clinical significance (e.g., triglycerides ≥500 mg/dL, capillary glucose ≥126 mg/dL, glycated hemoglobin ≥6.5%)
  • Uncontrolled hypertension
  • Recent major trauma or surgical event
  • Recent weight change ≥4.5 kg
  • History or presence of clinically important endocrine, cardiovascular, pulmonary, biliary, or gastrointestinal disorders
  • Recent history or presence of cancer (except non-melanoma skin cancer)
Show all 19Show fewer
  • History of extreme dietary habits
  • Vegan or vegetarian
  • History of eating disorder diagnosed by health professional
  • Known intolerance or sensitivity to study products
  • Unstable use of medications intended to alter lipid profile (e.g., unstable use of statins, bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin-drug form, or omega-3-acid ethyl ester drugs)
  • Recent use of foods or dietary supplements that might alter lipid metabolism (e.g., omega-3 fatty acid supplements or fortified foods, sterol/stanol products, pantethine, viscous dietary fiber supplements, red yeast supplements, garlic supplements, soy isoflavone supplements, probiotic supplements, niacin or analogues at >200 mg/d)
  • Recent use of medications known to influence carbohydrate metabolism (e.g., adrenergic blockers, diuretics, hypoglycemic medications, systemic corticosteroids)
  • Recent use of weight-loss drugs (including over-the-counter) or programs
  • Recent history or current use of supplements and/or medications known to influence, satiety, appetite, taste, sense of smell, or weight (e.g., hypoglycemic medications and systemic corticosteroids)
  • Recent use of antibiotics
  • Signs or symptoms of active infection of clinical relevance
  • Current or recent history of drug or alcohol abuse
  • Pregnant, planning to be pregnant, or lactating females or women of childbearing potential unwilling to commit to use of a medically approved form of contraception

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Illinois Institute of Technology - Institute for Food Safety and Health

    Chicago, Illinois, 60616

Other trials in United States

About this study

Official title: A Randomized, Controlled, Crossover Trial to Assess the Effects of a Lean Pork-containing, High-protein Breakfast on Indices of Satiety and Metabolic Health in Men and Women With Pre-diabetes

The goal of this study is to assess the effects of consumption of a lean pork-containing, high-protein breakfast versus a refined carbohydrate-rich breakfast on satiety and cardiometabolic parameters in overweight or obese adults with pre-diabetes.

Read the detailed description

This is a randomized, crossover trial that includes two screening visits, one baseline visit, and two test periods of 2 weeks each, each ending with a test visit, separated by a 2-week washout. Subjects consume each day a refined carbohydrate-rich breakfast containing 8/66/26% kcal from protein/carbohydrate/fat, respectively (Control Condition), or a high pork protein breakfast containing 35/39/26% kcal from protein/carbohydrate/fat, respectively (Active Condition). Study products for daily breakfast consumption will be dispensed to the subjects at the beginning of each test period. Subjects will complete 3-day diet records at baseline and the end of each test period, and a daily Appetite Visual Analog Scale (VAS) Diary to asses perceived hunger and fullness each evening before retiring throughout each test period. VAS assessments of hunger, fullness, desire to eat, prospective food consumption, focus and energy will also be assessed at the clinic visit at the end of each test period, pre- and post-breakfast consumption (multiple time points). Subjects will also complete a palatability questionnaire at the each of each test period. Blood samples will be collected at fasting at baseline and pre- and post-breakfast consumption (multiple sampling) at the end of each test period to evaluate glucose, insulin, and lipoprotein lipid concentrations.

Conditions
Pre-diabetes
Being tested
Refined carbohydrate-rich breakfast, High pork protein breakfast
Keywords
Pork, Refined carbohydrates, Satiety, Glucose, Insulin, Breakfast, Lipoprotein lipids
Medical subject headings
Glucose Intolerance, Insulin Resistance

What participants receive

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

  • Refined carbohydrate-rich breakfastOther

    Refined carbohydrate-rich breakfast containing approximately 8/66/26% kcal from protein/carbohydrate/fat, respectively

  • High pork protein breakfastOther

    High pork protein breakfast containing approximately 35/39/26% kcal from protein/carbohydrate/fat, respectively

Study groups in NCT02934425
Study groupRoleWhat they receive
Refined carbohydrate-rich breakfastPlacebo comparatorRefined carbohydrate-rich breakfast
Receives: Other: Refined carbohydrate-rich breakfast
High pork protein breakfastExperimentalHigh pork protein breakfast
Receives: Other: High pork protein breakfast

What is being measured

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

  1. Net incremental area under the curve (AUC) appetite VAS ratings

    Difference between test conditions in net incremental AUC from pre-consumption (t = -15 minutes) to t = 240 minutes for VAS ratings for appetite (fullness, hunger, desire to eat, prospective food consumption)

    Measured: 2 weeks

Secondary outcomes (11)

  1. Net incremental AUC focus and energy VAS ratings

    Difference between test conditions in net incremental AUC from pre-consumption (t = -15 minutes) to t = 240 minutes for VAS ratings for focus and energy

    Measured: 2 weeks

  2. Total AUC VAS ratings

    Difference between test conditions in total AUC from pre-consumption (t = -15 minutes) to t = 240 minutes for VAS ratings for appetite, focus and energy

    Measured: 2 weeks

  3. Individual time points for VAS ratings

    Difference between test conditions in fullness, hunger, desire to eat, prospective food consumption, and focus at individual time points from t = -15 minutes to t = 240 minutes

    Measured: 2 weeks

  4. Energy intake at lunch

    Difference between test conditions in the energy intake (kcal) at the lunch meal served at t = 240 minutes at the clinic visit at the end of each test period

    Measured: 2 weeks

  5. Glucose total AUC and incremental AUC

    Difference between test conditions in glucose total AUC and incremental AUC from 0 to 120 minutes and 0 to 240 minutes (the t = -15 minutes time point will be counted as t = 0 for this calculation)

    Measured: 2 weeks

  6. Insulin total AUC and incremental AUC

    Difference between test conditions in insulin total AUC and incremental AUC from 0 to 120 minutes and 0 to 240 minutes (the t = -15 minutes time point will be counted as t = 0 for this calculation)

    Measured: 2 weeks

  7. Homeostasis model assessment of insulin sensitivity (HOMA-%S)

    Difference between test conditions in HOMA-%S calculated from glucose and insulin values in samples collected at the end of each test period

    Measured: 2 weeks

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

    Difference between test conditions in HOMA-%B calculated from glucose and insulin values in samples collected at the end of each test period

    Measured: 2 weeks

  9. Lipoprotein lipids

    Difference between test conditions in percent changes from baseline (day 0) to the end of each test condition (days 14 and 42) in triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol

    Measured: 2 weeks

  10. Triglyceride postprandial total AUC and incremental AUC

    Difference between test conditions in postprandial total AUC and incremental AUC for triglycerides from 0 to 120 minutes and 0 to 240 minutes (the t = -15 minutes time point will be counted as t = 0 for this calculation)

    Measured: 2 weeks

  11. Composite daily hunger and fullness VAS ratings

    Difference between test conditions in the composite hunger and fullness VAS ratings from the daily Appetite VAS Dairy

    Measured: 2 weeks

Timeline

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

  1. First posted17 Oct 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02934425
Sponsor's protocol ID
MC-1601
Status last verified
May 2018
First submitted
13 Oct 2016
Last updated
15 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Refined carbohydrate-rich breakfast and High pork protein breakfast in people with Pre-diabetes, run by Midwest Center for Metabolic and Cardiovascular 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 5 inclusion and 19 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 15 May 2018. 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?

Net incremental area under the curve (AUC) appetite VAS ratings (time frame: 2 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 NCT02934425.

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 15 May 2018.

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