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Physical InactivityNCT03013764

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

A study testing normal protein diet and high protein intake in people with Physical Inactivity and Dietary Protein, run by University of Missouri-Columbia 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

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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Physical Inactivity, Dietary Protein
What is being tested?
normal protein diet and high protein intake
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited States
Study dates
Oct 2015to 30 Sep 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Missouri

    Columbia, Missouri, 65211

Other trials in United States

About this study

Official title: Interaction Between Diet Composition and Physical Inactivity on Insulin Sensitivity and β-cell Function

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 \&lt;5,000 steps/d while consuming either a HP or NP diet. Completion of the study will take 8-10 weeks.

Read the detailed description

It is well known that insulin resistance increases the risk of cardiovascular disease and type 2 diabetes, which substantially impact mortality and morbidity and presents a significant economic burden. Energy restriction with or without exercise has been demonstrated to attenuate/reverse the development of insulin resistance and reduce the risk of cardiovascular disease and type 2 diabetes. Indeed, accumulating evidence suggests that diets high in protein may possess additional protection against the development of insulin resistance during energy restriction. Layman et al. found that a high protein diet (HP) (PRO 125 g/d) compared with an isocaloric high carbohydrate diet (HCHO) (PRO 68 g/d) resulted in greater reductions in fasting glucose and 2 h postprandial insulin levels during 16 weeks of energy restriction in overweight women. Similarly, a hypocaloric high protein diet (PRO 45% vs 20%; 21 d diet treatment) increased glucose oxidation and improved insulin sensitivity compared to an isocaloric high carbohydrate diet during a euglycemic hyperinsulinemic clamp procedure. In addition, markers of inflammation, β-cell function, and postprandial glucose and insulin levels were improved in addition to increased resting energy expenditure after 6 months of hypocaloric HP compared with HCHO diet in premenopausal women independent of weight loss. The increase in REE and improvement in adipose tissue function may be a potential mechanism by which HP diet improves β-cell function since NEFAs are lower, which may reduce lipotoxicity on the pancreas.

It is evident that physical inactivity (highlighted from bed rest studies) impairs glucose tolerance, insulin sensitivity, vascular function, and muscle protein synthesis in both healthy and obese individuals. This model of inactivity, however, is extreme and does not recapitulate the physical inactivity paradigm seen in the natural human environment. Consequently, a less extreme reduction in daily physical activity (>10,000 steps/d to ~1,500 steps/d) results in significant reductions in insulin sensitivity, glucose tolerance, and insulin-stimulated muscle Akt phosphorylation, suggesting that the impairments in insulin sensitivity and glucose tolerance precede changes in body composition. A reduction in ambulatory activity is a highly valid and translatable model to study the role of inactivity on the development of metabolic disease, as most individuals go through periods of inactivity, and it has been shown that a reduction in daily steps decreases insulin sensitivity and increases visceral adiposity. To date, no study has tested the effects of diet composition on the perturbations of physical inactivity. It is important to know if increasing protein intake mitigates the negative perturbations of reduced ambulatory activity.

Thus, the overall objective of this project is to determine the extent to which short-term high protein (HP) feeding may protect against the metabolic perturbations of physical inactivity (i.e. PPG, hyperinsulinemia, and insulin sensitivity). The investigators will also examine measures of vascular function and free living blood pressure in addition to lipemic responses (i.e. FFAs, triglycerides, cholesterol, and lipoproteins) to determine if HP diet impacts vascular function and lipemic responses during short term physical inactivity.

Trial Objectives and Purpose

The specific aims of this project include the following:

Specific Aim 1: To determine if HP diet during a period of low physical activity will lower the insulin response to a meal, and help to maintain insulin sensitivity and β-cell function during a laboratory based mixed meal test (MMT) with stable isotope tracers.

Specific Aim 2: To determine if a HP diet during a period of low physical activity will maintain glycemic control measured by continuous glucose monitoring (CGM) in healthy, recreationally active, young individuals.

Being tested
normal protein diet, high protein intake
Medical subject headings
Sedentary Behavior

What participants receive

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

  • normal protein dietBehavioural

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

  • high protein intakeBehavioural

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

Study groups in NCT03013764
Study groupRoleWhat they receive
normal protein intakePlacebo comparatorsubjects will undergo 10 days of low physical activity while consuming a normal protein diet
Receives: Behavioral: normal protein diet
high protein intakeExperimentalsubjects will undergo 10 days of low physical activity while consuming a high protein diet
Receives: Behavioral: high protein intake

What is being measured

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

  1. glucose excursions

    Measured: change in from baseline

Secondary outcomes (5)
  1. insulin sensitivity

    Measured: change in from baseline

  2. blood lipids

    Measured: change in from baseline

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

    Measured: change in from baseline

  4. endothelial function

    Measured: change in from baseline

  5. beta cell function

    Measured: change in from baseline

Timeline

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

  1. First posted6 Jan 2017 (estimated)
  2. Study startOct 2015
  3. Primary completion30 Sep 2017
  4. Study completion30 Sep 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
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03013764
Sponsor's protocol ID
American Egg Board - 00050021
Status last verified
Oct 2018
First submitted
20 Dec 2016
Last updated
15 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30694977

Questions about this trial

What is this clinical trial studying?

A study testing normal protein diet and high protein intake in people with Physical Inactivity and Dietary Protein, run by University of Missouri-Columbia 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 6 inclusion and 8 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 Oct 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?

glucose excursions (time frame: change in from baseline). 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 NCT03013764, 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 15 Oct 2018.

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