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

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Refined carbohydrate-rich breakfast
High pork protein breakfast
Sponsored by
Midwest Center for Metabolic and Cardiovascular Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring Pork, Refined carbohydrates, Satiety, Glucose, Insulin, Breakfast, Lipoprotein lipids

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Refined carbohydrate-rich breakfast

High pork protein breakfast

Arm Description

Refined carbohydrate-rich breakfast

High pork protein breakfast

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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
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)
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)
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
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
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
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)
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

Full Information

First Posted
October 13, 2016
Last Updated
May 11, 2018
Sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
National Pork Board
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1. Study Identification

Unique Protocol Identification Number
NCT02934425
Brief Title
Effects of Lean Pork, High Protein Breakfast on Satiety and Metabolic Health in Pre-diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
National Pork Board

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Pork, Refined carbohydrates, Satiety, Glucose, Insulin, Breakfast, Lipoprotein lipids

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refined carbohydrate-rich breakfast
Arm Type
Placebo Comparator
Arm Description
Refined carbohydrate-rich breakfast
Arm Title
High pork protein breakfast
Arm Type
Experimental
Arm Description
High pork protein breakfast
Intervention Type
Other
Intervention Name(s)
Refined carbohydrate-rich breakfast
Intervention Description
Refined carbohydrate-rich breakfast containing approximately 8/66/26% kcal from protein/carbohydrate/fat, respectively
Intervention Type
Other
Intervention Name(s)
High pork protein breakfast
Intervention Description
High pork protein breakfast containing approximately 35/39/26% kcal from protein/carbohydrate/fat, respectively
Primary Outcome Measure Information:
Title
Net incremental area under the curve (AUC) appetite VAS ratings
Description
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)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Net incremental AUC focus and energy VAS ratings
Description
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
Time Frame
2 weeks
Title
Total AUC VAS ratings
Description
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
Time Frame
2 weeks
Title
Individual time points for VAS ratings
Description
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
Time Frame
2 weeks
Title
Energy intake at lunch
Description
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
Time Frame
2 weeks
Title
Glucose total AUC and incremental AUC
Description
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)
Time Frame
2 weeks
Title
Insulin total AUC and incremental AUC
Description
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)
Time Frame
2 weeks
Title
Homeostasis model assessment of insulin sensitivity (HOMA-%S)
Description
Difference between test conditions in HOMA-%S calculated from glucose and insulin values in samples collected at the end of each test period
Time Frame
2 weeks
Title
Homeostasis model assessment of pancreatic beta-cell function (HOMA-%B)
Description
Difference between test conditions in HOMA-%B calculated from glucose and insulin values in samples collected at the end of each test period
Time Frame
2 weeks
Title
Lipoprotein lipids
Description
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
Time Frame
2 weeks
Title
Triglyceride postprandial total AUC and incremental AUC
Description
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)
Time Frame
2 weeks
Title
Composite daily hunger and fullness VAS ratings
Description
Difference between test conditions in the composite hunger and fullness VAS ratings from the daily Appetite VAS Dairy
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indika Edirisinghe, PhD
Organizational Affiliation
Illinois Institute of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin C Maki, PhD
Organizational Affiliation
Midwest Center for Metabolic and Cardiovascular Research
Official's Role
Study Director
Facility Information:
Facility Name
Illinois Institute of Technology - Institute for Food Safety and Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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