HealthyXONCT02701738
Impact of Exercise on the Metabolic Consequences of Overeating
A study testing Overeating Protocol in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
The primary purpose of this study is to examine the effects of 1-week of overeating on important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile, and blood pressure) and factors regulating the structure and metabolic function of fat tissue. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Overeating Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2016to 8 Dec 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40
- Body Mass Index: 20-30 kg/m2
- Exercise group: (≥5 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
- No Exercise group: no regularly planned exercise/physical activity
- Women must have regularly occurring menses and must be premenopausal
Who cannot join
- Pregnant or lactating
- Blood pressure > 140/90 mm Hg
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism
- Tobacco or electronic cigarette user
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to examine the effects of 1-week of overeating on important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile, and blood pressure) and factors regulating the structure and metabolic function of fat tissue. This study will determine how regular exercise during this overeating period impacts these responses.
Read the detailed description
If subjects are eligible and decide to participate, they will take part in two identical study trials. One is scheduled before and the other is scheduled after 1 week of overeating controlled by the study team. Subjects who exercise regularly will be instructed to exercise the day before their first study trial - and they will be required to exercise during 6 of the 7 days of the overeating period (including the day before their second study trial). Subjects who do not regularly exercise (no planned physical activity) will remain inactive until the completion of both study trials.
Before each study trial If a subject is a regular exerciser, they will be asked to come to the Substrate Metabolism Laboratory in the afternoon before each of the 2 study trials to exercise in the lab for 45 min at a moderate intensity. The evening before the study trial, all subjects will need to eat a standardized dinner meal and snack. They must eat the meal and snack at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight.
During each study trial Subjects will arrive at the Substrate Metabolism Laboratory at 7:00AM and will rest quietly for approximately 30 min. After which, the study team will measure their resting blood pressure and their resting metabolic rate. An intravenous catheter (IV) will then be placed in a vein of the subject's hand or forearm for blood sampling. The research team will then collect a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will drink a sweet sugar solution for an Oral Glucose Tolerance Test (OGTT) and the research team will collect blood samples every 15 min for 3 hours. After this 3 hour test, the IV catheter will be removed and subjects will be provided breakfast and discharged.
- Conditions
- Healthy
- Being tested
- Overeating Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overeating ProtocolDietary supplement
Subjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein.
| Study group | Role | What they receive |
|---|---|---|
| Overeating Protocol | Experimental | Subjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein. Receives: Dietary Supplement: Overeating Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Glucose Tolerance
An index of insulin sensitivity will be measured using the plasma insulin and glucose concentrations during the 3h OGTT
Measured: up to 1 week
Secondary outcomes (3)
Resting Metabolic Rate
Measured: baseline and 1 week
Total Cholesterol
Plasma concentrations of total- cholesterol will be measured
Measured: baseline and 1 week
PPARg mRNA expression
cytokine proteins will be measured in adipose tissue
Measured: baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start12 Jan 2016
- Primary completion8 Dec 2017
- Study completion8 Dec 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 HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey F Horowitz, University of Michigan
- Investigators
- Jeffrey F Horowitz, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701738
- Sponsor's protocol ID
- HUM00102772
- Acronym
- XO
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2016
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Ludzki AC, Krueger EM, Gillen JB, Taylor NM, Middlebrook DO, Baldwin TC, Karabetsos KC, Schleh MW, Horowitz JF. One week of overeating upregulates angiogenic and lipolytic gene expression in human subcutaneous adipose tissue from exercise trained and untrained adults. Appl Physiol Nutr Metab. 2022 Oct 1;47(10):992-1004. doi: 10.1139/apnm-2022-0078. Epub 2022 Jul 11.
PubMed 35816737
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise on the Metabolic Consequences of Overeating
- ClinicalTrials.gov ID
- NCT02701738
- Acronym / sponsor ID
- XO / HUM00102772
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Jan 2016
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 8 Mar 2016 (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.
The primary purpose of this study is to examine the effects of 1-week of overeating on important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile, and blood pressure) and factors regulating the structure and metabolic function of fat tissue. This study will determine how regular exercise during this overeating period impacts these responses.
Detailed description
If subjects are eligible and decide to participate, they will take part in two identical study trials. One is scheduled before and the other is scheduled after 1 week of overeating controlled by the study team. Subjects who exercise regularly will be instructed to exercise the day before their first study trial - and they will be required to exercise during 6 of the 7 days of the overeating period (including the day before their second study trial). Subjects who do not regularly exercise (no planned physical activity) will remain inactive until the completion of both study trials.
Before each study trial If a subject is a regular exerciser, they will be asked to come to the Substrate Metabolism Laboratory in the afternoon before each of the 2 study trials to exercise in the lab for 45 min at a moderate intensity. The evening before the study trial, all subjects will need to eat a standardized dinner meal and snack. They must eat the meal and snack at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight.
During each study trial Subjects will arrive at the Substrate Metabolism Laboratory at 7:00AM and will rest quietly for approximately 30 min. After which, the study team will measure their resting blood pressure and their resting metabolic rate. An intravenous catheter (IV) will then be placed in a vein of the subject's hand or forearm for blood sampling. The research team will then collect a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will drink a sweet sugar solution for an Oral Glucose Tolerance Test (OGTT) and the research team will collect blood samples every 15 min for 3 hours. After this 3 hour test, the IV catheter will be removed and subjects will be provided breakfast and discharged.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overeating Protocol | Experimental | Dietary Supplement: Overeating ProtocolSubjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18-40
- Body Mass Index: 20-30 kg/m2
- Exercise group: (≥5 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
- No Exercise group: no regularly planned exercise/physical activity
- Women must have regularly occurring menses and must be premenopausal
Key exclusion criteria (5 listed)
- Pregnant or lactating
- Blood pressure > 140/90 mm Hg
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism
- Tobacco or electronic cigarette user
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 |
|---|---|---|
| Overeating ProtocolSubjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein. | Dietary supplement | Overeating Protocol |
Primary outcome
Oral Glucose Tolerance
Time frame: up to 1 week
An index of insulin sensitivity will be measured using the plasma insulin and glucose concentrations during the 3h OGTT
3 secondary outcomes
Resting Metabolic Rate
Time frame: baseline and 1 week
Total Cholesterol
Time frame: baseline and 1 week
PPARg mRNA expression
Time frame: baseline and 1 week
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 21 Mar 2022.
- Derived from this study: PubMed 35816737Ludzki AC, Krueger EM, Gillen JB, Taylor NM, Middlebrook DO, Baldwin TC, Karabetsos KC, Schleh MW, Horowitz JF. One week of overeating upregulates angiogenic and lipolytic gene expression in human subcutaneous adipose tissue from exercise trained and untrained adults. Appl Physiol Nutr Metab. 2022 Oct 1;47(10):992-1004. doi: 10.1139/apnm-2022-0078. Epub 2022 Jul 11.
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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.
Jeffrey F Horowitz 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 Overeating Protocol in people with Healthy, 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 5 inclusion and 5 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 21 Mar 2022. 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?
Oral Glucose Tolerance (time frame: up to 1 week). 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 NCT02701738, 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 21 Mar 2022.