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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 \<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.
- Conditions
- Physical Inactivity, Dietary Protein
- 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 group | Role | What they receive |
|---|---|---|
| normal protein intake | Placebo comparator | subjects will undergo 10 days of low physical activity while consuming a normal protein diet Receives: Behavioral: normal protein diet |
| high protein intake | Experimental | subjects 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.
glucose excursions
Measured: change in from baseline
Secondary outcomes (5)
insulin sensitivity
Measured: change in from baseline
blood lipids
Measured: change in from baseline
insulin, FFA and other hormones (e.g. glucagon, adropin, etc)
Measured: change in from baseline
endothelial function
Measured: change in from baseline
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.
- First posted6 Jan 2017 (estimated)
- Study startOct 2015
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
- Investigators
- jill kanaley, Phd, Principal investigator, University of Missouri-Columbia
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Diet Composition and Physical Inactivity on Insulin Sensitivity and β-cell Function
- ClinicalTrials.gov ID
- NCT03013764
- Acronym / sponsor ID
- American Egg Board - 00050021
- Conditions
- Physical Inactivity, Dietary Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- Oct 2015
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal protein intake | Placebo comparator | Behavioral: normal protein dietsubjects will undergo 10 days of low physical activity while consuming a normal protein diet |
| high protein intake | Experimental | Behavioral: high protein intakesubjects will undergo 10 days of low physical activity while consuming a high protein diet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal protein dietsubjects will undergo 10 days of low physical activity while consuming a normal protein diet | Behavioural | normal protein intake |
| high protein intakesubjects will undergo 10 days of low physical activity while consuming a high protein diet | Behavioural | high protein intake |
Primary outcome
glucose excursions
Time frame: change in from baseline
5 secondary outcomes
insulin sensitivity
Time frame: change in from baseline
blood lipids
Time frame: change in from baseline
insulin, FFA and other hormones (e.g. glucagon, adropin, etc)
Time frame: change in from baseline
endothelial function
Time frame: change in from baseline
beta cell function
Time frame: change in from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 30694977Winn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jill kanaley, Phd principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
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.