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

NCT02934425 | Completed

• 1 other identifier: MC-1601
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

Pork; Refined carbohydrates; Satiety; Glucose; Insulin; Breakfast; Lipoprotein lipids

Outcome Measures

Primary Outcomes (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)

  2 weeks

Secondary Outcomes (11)

• Net incremental AUC focus and energy VAS ratings

  2 weeks

• Total AUC VAS ratings

  2 weeks

• Individual time points for VAS ratings

  2 weeks

• Energy intake at lunch

  2 weeks

• Glucose total AUC and incremental AUC

  2 weeks

Study Arms (2)

Refined carbohydrate-rich breakfast

PLACEBO COMPARATOR

Refined carbohydrate-rich breakfast

Other: Refined carbohydrate-rich breakfast

High pork protein breakfast

EXPERIMENTAL

High pork protein breakfast

Other: High pork protein breakfast

Interventions

Refined carbohydrate-rich breakfast OTHER

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

Refined carbohydrate-rich breakfast

High pork protein breakfast OTHER

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

High pork protein breakfast

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• National Pork Board: collaborator

Study Sites (1)

Illinois Institute of Technology - Institute for Food Safety and Health

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Indika Edirisinghe, PhD

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

• Kevin C Maki, PhD

  Midwest Center for Metabolic and Cardiovascular Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 17, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)