Endocrine and Metabolic Responses to Exercise and DietsXFGNCT01891617
Exercise Effects on Insulin, Gut Peptides, and Appetite
A study testing Exercise and diets in people with Endocrine and Metabolic Responses to Exercise and Diets, run by University of Michigan at 1 site in United States.
Trial summary
Determine whether the mid-day suppression of hunger and amplified increase in the release of glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) following morning exercise is due to increased fat content of the diet per se or a combination of high fat diet after morning exercise. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endocrine and Metabolic Responses to Exercise and Diets
- What is being tested?
- Exercise and diets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2013
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal status
- Age 50 to 65 years
- BMI between 20 and 30 kg/m2.
- Good health status (normotensive, fasting glucose < 100 mg/dl, , hematocrit > 32%, hemoglobin >12 mg/dl)
- Absence of restricted food intake
- Absence of endocrine and metabolic disorders requiring medication other than hormonally corrected hypothyroidism
- Absence of musculoskeletal disabilities that would prevent walking
Who cannot join
- Presence of endocrine and metabolic disease requiring medication, other than hormonally corrected hypothyroidism
- Presence of musculoskeletal disabilities that would prevent walking
- Smoking
- Active dieting
- Absence of listed inclusion criteria
- Unwillingness to follow study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Clinical Research Unit
Ann Arbor, Michigan, 48109
About this study
Official title: The Exercise Effects on Appetite and Gut Peptides While on High-fat Diet
Determine whether the mid-day suppression of hunger and amplified increase in the release of glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) following morning exercise is due to increased fat content of the diet per se or a combination of high fat diet after morning exercise. The action of gut peptides, particularly GLP-1, on gastric emptying is likely to be important in mediating its effects on postprandial appetite and glycemia (Nauck et al. 1997). Our hypothesis is that exercise amplifies gut peptide secretion when diet is enriched with fat, and that this stimulus suppresses the hunger sensation.
Read the detailed description
Specific aim: Determine whether a change in macronutrient composition from 60% carbohydrate and 25% fat to 30% carbohydrate and 45% fat is responsible by itself for suppression of hunger and increased secretory response of glucose-dependent insulinotropic hormone (GIP) and glucagon-like peptide-1 (GLP-1), or whether these changes depend on preceding exercise. We will measure (a) concentrations of plasma GIP and GLP-1 by chemiluminescent multiplex assay, (b) concentrations of plasma ancetaminophen to assess the gastric emptying rate, (c) concentrations of plasma insulin, and glucagon by radioimmunoassay, and glucose, ketone bodies, and free fatty acids with appropriate spectrophotometric methods, (d) hourly appetite responses with visual analog scale under two conditions: sedentary (SED) and exercise (EX).
Hypothesis: Hunger suppression and secretion of GIP and GLP-1 after the morning meal will be greater with slower gastric emptying rate when a meal consisting of 45% fat and 30% carbohydrate follows three hours after a 2-hour bout of moderate-intensity exercise than in the absence of exercise.
- Being tested
- Exercise and diets
- Keywords
- exercise, high carbohydrate and high fat diets, insulin, gut peptides, appetite, metabolism, glucose
- Medical subject headings
- Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and dietsOther
Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
| Study group | Role | What they receive |
|---|---|---|
| Exercise-high-fat diet | Experimental | Two bouts of exercise followed by a high-fat meal Receives: Other: Exercise and diets |
| Exercise-high-carbohydrate diet | Experimental | Two bouts of exercise followed by a high-carbohydrate meal Receives: Other: Exercise and diets |
| Sedentary-high-fat diet | Experimental | Sedentary trial with two high-fat meals Receives: Other: Exercise and diets |
| Sedentary-high-carbohydrate diet | Experimental | Sedentary trial with two high-carbohydrate meals Receives: Other: Exercise and diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma insulin concentration
Change in plasma insulin to two bouts of exercise followed by a high-carbohydrate or a high fat diet
Measured: 36 hours
Plasma glucagon concentration
Changes in plasma glucagon concentration to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Measured: 36 hours
Plasma concentration of glucose-dependent insulinotropic peptide (GIP)
Changes in plasma concentration of glucose-dependent insulinotropic peptide (GIP)to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Measured: 36 hours
Plasma concentration of free fatty acids
Changes in plasma concentration of free fatty acidsto two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Measured: 36 hours
Plasma concentration of beta-hydroxybutyrate
Changes in plasma concentration of beta-hydroxybutyrate to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Measured: 36 hours
Plasma glucose concentration
Changes in plasma glucose concentration to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Measured: 36 hours
daytime hourly appetite ratings
Changes in daytime hourly appetite ratings to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Measured: 36 hours
Secondary outcomes (2)
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
Changes in plasma concentrations of glucagon-like peptide-1 (GLP-1)to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Measured: 36 hours
Plasma concentrations of peptide tyrosine tyrosine (PYY)
Changes in plasma concentrations of peptide tyrosine tyrosine (PYY) to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startNov 2010
- Primary completionJul 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine and Metabolic Responses to Exercise and DietsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Katarina Borer, University of Michigan
- Investigators
- Katarina Borer, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891617
- Sponsor's protocol ID
- R15DK082800-XFG
- Other IDs
- R15DK082800
- Acronym
- XFG
- Status last verified
- Jun 2016
- First submitted
- 26 Jun 2013
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exercise Effects on Appetite and Gut Peptides While on High-fat Diet
- ClinicalTrials.gov ID
- NCT01891617
- Acronym / sponsor ID
- XFG / R15DK082800-XFG
- Keywords
- exercise, high carbohydrate and high fat diets, insulin, gut peptides, appetite, metabolism, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Jul 2013 (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.
Determine whether the mid-day suppression of hunger and amplified increase in the release of glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) following morning exercise is due to increased fat content of the diet per se or a combination of high fat diet after morning exercise. The action of gut peptides, particularly GLP-1, on gastric emptying is likely to be important in mediating its effects on postprandial appetite and glycemia (Nauck et al. 1997). Our hypothesis is that exercise amplifies gut peptide secretion when diet is enriched with fat, and that this stimulus suppresses the hunger sensation.
Detailed description
Specific aim: Determine whether a change in macronutrient composition from 60% carbohydrate and 25% fat to 30% carbohydrate and 45% fat is responsible by itself for suppression of hunger and increased secretory response of glucose-dependent insulinotropic hormone (GIP) and glucagon-like peptide-1 (GLP-1), or whether these changes depend on preceding exercise. We will measure (a) concentrations of plasma GIP and GLP-1 by chemiluminescent multiplex assay, (b) concentrations of plasma ancetaminophen to assess the gastric emptying rate, (c) concentrations of plasma insulin, and glucagon by radioimmunoassay, and glucose, ketone bodies, and free fatty acids with appropriate spectrophotometric methods, (d) hourly appetite responses with visual analog scale under two conditions: sedentary (SED) and exercise (EX).
Hypothesis: Hunger suppression and secretion of GIP and GLP-1 after the morning meal will be greater with slower gastric emptying rate when a meal consisting of 45% fat and 30% carbohydrate follows three hours after a 2-hour bout of moderate-intensity exercise than in the absence of exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise-high-fat diet | Experimental | Other: Exercise and dietsTwo bouts of exercise followed by a high-fat meal |
| Exercise-high-carbohydrate diet | Experimental | Other: Exercise and dietsTwo bouts of exercise followed by a high-carbohydrate meal |
| Sedentary-high-fat diet | Experimental | Other: Exercise and dietsSedentary trial with two high-fat meals |
| Sedentary-high-carbohydrate diet | Experimental | Other: Exercise and dietsSedentary trial with two high-carbohydrate meals |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal status
- Age 50 to 65 years
- BMI between 20 and 30 kg/m2.
- Good health status (normotensive, fasting glucose < 100 mg/dl, , hematocrit > 32%, hemoglobin >12 mg/dl)
- Absence of restricted food intake
Key exclusion criteria (6 listed)
- Presence of endocrine and metabolic disease requiring medication, other than hormonally corrected hypothyroidism
- Presence of musculoskeletal disabilities that would prevent walking
- Smoking
- Active dieting
- Absence of listed inclusion criteria
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 |
|---|---|---|
| Exercise and dietsExercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet | Other | Exercise-high-carbohydrate diet, Exercise-high-fat diet, Sedentary-high-carbohydrate diet, Sedentary-high-fat diet |
Primary outcome
Plasma insulin concentration
Time frame: 36 hours
Change in plasma insulin to two bouts of exercise followed by a high-carbohydrate or a high fat diet
Plasma glucagon concentration
Time frame: 36 hours
Changes in plasma glucagon concentration to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Plasma concentration of glucose-dependent insulinotropic peptide (GIP)
Time frame: 36 hours
Changes in plasma concentration of glucose-dependent insulinotropic peptide (GIP)to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Plasma concentration of free fatty acids
Time frame: 36 hours
Changes in plasma concentration of free fatty acidsto two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Plasma concentration of beta-hydroxybutyrate
Time frame: 36 hours
Changes in plasma concentration of beta-hydroxybutyrate to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
Plasma glucose concentration
Time frame: 36 hours
Changes in plasma glucose concentration to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
daytime hourly appetite ratings
Time frame: 36 hours
Changes in daytime hourly appetite ratings to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
2 secondary outcomes
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
Time frame: 36 hours
Plasma concentrations of peptide tyrosine tyrosine (PYY)
Time frame: 36 hours
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 13 Jun 2016.
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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.
Katarina Borer, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and diets in people with Endocrine and Metabolic Responses to Exercise and Diets, run by University of Michigan 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 7 inclusion and 6 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 13 Jun 2016. 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. 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?
Plasma insulin concentration (time frame: 36 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2016.