Diet Composition and Physical Inactivity on Insulin Sensitivity and β-cell Function

NCT03013764 | Completed

• 1 other identifier: American Egg Board - 00050021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Physical inactivity results in reductions in glucose tolerance and less sensitivity to insulin. If this inactivity lasts long enough it can result in insulin resistance and type 2 diabetes. A high protein diet can reduce elevated glucose levels in individuals with type 2 diabetes. Thus the investigators are interested in establishing if during a period of inactivity if a diet modification can minimize the glucose changes normally observed with inactivity. The objective of this project is to determine if short-term high protein (HP) feeding protects against the changes in glucose levels normally observed with physical inactivity. The investigators will also examine measures of blood vessel function, blood lipid and blood pressure. Twelve subjects will complete two 10 day study periods of reduced physical activity and will be studied before and after each of these study periods. For their testing subjects will have the following measurements: postprandial glucose responses to a mixed meal, 24 h free living blood pressure control during acute physical inactivity, blood lipids, changes in body composition, changes in circadian rhythm using skin temperature (ibutton), measurement of aerobic capacity (VO2 max), blood vessel responsiveness (flow mediated dilation -FMD) and changes in free living glucose levels (continuous glucose monitoring system (CGMS). Subjects will complete two conditions (high protein -HP vs normal protein - NP diets) in a randomized cross-over design. In the inactive phase subjects will reduce there steps to \<5,000 steps/d while consuming either a HP or NP diet. Completion of the study will take 8-10 weeks.

Conditions

Physical Inactivity; Dietary Protein

Outcome Measures

Primary Outcomes (1)

• glucose excursions

  change in from baseline

Secondary Outcomes (5)

• insulin sensitivity

  change in from baseline

• blood lipids

  change in from baseline

• insulin, FFA and other hormones (e.g. glucagon, adropin, etc)

  change in from baseline

• endothelial function

  change in from baseline

• beta cell function

  change in from baseline

Study Arms (2)

normal protein intake

PLACEBO COMPARATOR

subjects will undergo 10 days of low physical activity while consuming a normal protein diet

Behavioral: normal protein diet

high protein intake

EXPERIMENTAL

subjects will undergo 10 days of low physical activity while consuming a high protein diet

Behavioral: high protein intake

Interventions

normal protein diet BEHAVIORAL

subjects will undergo 10 days of low physical activity while consuming a normal protein diet

normal protein intake

high protein intake BEHAVIORAL

subjects will undergo 10 days of low physical activity while consuming a high protein diet

high protein intake

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \<28 kg/m2
• No known cardiovascular, kidney, or liver disease.
• No history of surgery for weight loss and weight stable for prior 3 months (weight change \< 3 kg).
• Physically active individual (90 minutes of primarily whole body aerobic physical activity \<3 days per week and taking greater than 10,000 steps per day)
• Between 18-45 yr of age.
• Participants who consume on average less than 18% of total calories as protein

You may not qualify if:

• History of alcohol use (\< 20 g/day for males and \> 10 g/day for females)
• Smoker.
• BMI \< 28 kg/m2
• Kidney or liver disease.
• Physically inactive (completing \< 75 min of whole body aerobic activity \<3 times per week or obtaining \<10,000 steps/day)
• Pregnant or lactating
• \<18 or \>45 yr of age
• High protein consumers (\>20% of total daily calories as protein)

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• American Egg Board: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

• Winn NC, Pettit-Mee R, Walsh LK, Restaino RM, Ready ST, Padilla J, Kanaley JA. Metabolic Implications of Diet and Energy Intake during Physical Inactivity. Med Sci Sports Exerc. 2019 May;51(5):995-1005. doi: 10.1249/MSS.0000000000001892.

  PMID: 30694977 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• jill kanaley, Phd

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 6, 2017
• Study Start: October 1, 2015
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)