HealthyNCT02809482
White Adipose Tissue Clocks and High Calorie Feeding
A study testing Eucaloric feeding and Overfeeding in people with Healthy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is highly sensitive to feeding-fasting signals across the sleep-wake transition. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Eucaloric feeding and Overfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males and females aged 20-35 yr;
- BMI 25-35 kg/m2 and weight stable (±2kg in past 2mo);
- non-smoker;
- sedentary to moderately active (≤3 days of exercise per week ≤30 min of exercise per session);
- sleeping pattern of >7 hours to 9.25 hrs of sleep/night.
- subjects will be asked to identify themselves as regular consumers of 3 balanced meals per day by answering the question: "Do you eat breakfast, lunch, and dinner on ≥ 5 days per week?"
Who cannot join
- Smoker (current or within the previous 3 months);
- Use any medication that could affect lipid metabolism, insulin signaling, or sleep;
- Pregnant women will not be enrolled in the study;
- Have a job that involves shift work;
- Dwelling below Denver altitude (1,600 m) a year prior to testing;
- Travel across more than one time zone 3 wk before a study;
Show all 16Show fewer
- chronic health conditions such as diabetes, hyper or hypothyroidism, renal or liver disease, anemia, or cancer;
- Regularly go to sleep after midnight;
- o Subjects will be excluded if they are identified as having night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
- Allergy to lidocaine or similar compound;
- Have one or more of the following out-of-range values measured on a fasting blood sample:
- glucose > 110 mg/dl,
- thyroid stimulating hormone <0.5 or >5.0 µU/ml.
- Subjects who may be:
- anemic (hemoglobin < 14.5 g/dl men, <12.3 g/dl women ),
- have abnormal liver function tests (alanine amino transferase > 47 U/l, aspartate aminotransferase, > 47 U/l, alkaline phosphatase <39 or >117 U/l) or creatinine (>1.1 mg/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Examine the Impact of Overfeeding on Peripheral Clock Gene Expression in Humans
Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene expression in peripheral tissues resulting in a deleterious re-programming of the circadian metabolome. Studies in humans have only superficially investigated how the circadian clock machinery is impacted by nutritional signals. The overall goal of this pilot project is to take the first steps toward developing translational methods to investigate links between changes in energy flux and the circadian system in human tissues. Using an innovative ex vivo cell culture approach the investigators will examine the impact of 3-days of HF-OF compared to eucaloric (EU) feeding on the expression of core clock genes in human subcutaneous adipose tissue (SAT). The Investigators hypothesize that compared to EU, the amplitude of clock gene expression in SAT measured over 24hrs will be attenuated following short-term HF-OF. This pilot project will serve as a launch point for designing future studies into the effects of diet and exercise on the circadian control of metabolism in adipose tissue depots as well as other tissues (e.g. muscle).
- Conditions
- Healthy
- Being tested
- Eucaloric feeding, Overfeeding
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eucaloric feedingOther
3 days of a diet designed to maintain energy balance
OverfeedingOther
3 days of a diet designed to induce a 40% positive energy balance
| Study group | Role | What they receive |
|---|---|---|
| Eucaloric Feeding | Other | Not described Receives: Other: Eucaloric feeding |
| Overfeeding | Other | Not described Receives: Other: Overfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of clock genes in adipose tissue.
Gene expression measured at two time points from abdominal fat.
Measured: Measured through study completion, an average of 4 weeks.
Secondary outcomes (2)
Gene expression of key cellular fuel sensors thought to be controlled. and/or influenced by peripheral clocks
Gene expression measured at two time points from abdominal fat.
Measured: Measured through study completion, an average of 4 weeks.
Expression of clock genes in blood monocytes.
Gene expression measured at two time points from abdominal fat.
Measured: Measured through study completion, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Colorado, DenverThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Bessesen, MD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809482
- Sponsor's protocol ID
- 15-1570
- Other IDs
- UL1TR001082
- Status last verified
- Jun 2019
- First submitted
- 7 Dec 2015
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yoo SH, Yamazaki S, Lowrey PL, Shimomura K, Ko CH, Buhr ED, Siepka SM, Hong HK, Oh WJ, Yoo OJ, Menaker M, Takahashi JS. PERIOD2::LUCIFERASE real-time reporting of circadian dynamics reveals persistent circadian oscillations in mouse peripheral tissues. Proc Natl Acad Sci U S A. 2004 Apr 13;101(15):5339-46. doi: 10.1073/pnas.0308709101. Epub 2004 Feb 12.
PubMed 14963227Oosterman JE, Kalsbeek A, la Fleur SE, Belsham DD. Impact of nutrients on circadian rhythmicity. Am J Physiol Regul Integr Comp Physiol. 2015 Mar 1;308(5):R337-50. doi: 10.1152/ajpregu.00322.2014. Epub 2014 Dec 17.
PubMed 25519730Eckel-Mahan KL, Patel VR, de Mateo S, Orozco-Solis R, Ceglia NJ, Sahar S, Dilag-Penilla SA, Dyar KA, Baldi P, Sassone-Corsi P. Reprogramming of the circadian clock by nutritional challenge. Cell. 2013 Dec 19;155(7):1464-78. doi: 10.1016/j.cell.2013.11.034.
PubMed 24360271Pivovarova O, Jurchott K, Rudovich N, Hornemann S, Ye L, Mockel S, Murahovschi V, Kessler K, Seltmann AC, Maser-Gluth C, Mazuch J, Kruse M, Busjahn A, Kramer A, Pfeiffer AF. Changes of Dietary Fat and Carbohydrate Content Alter Central and Peripheral Clock in Humans. J Clin Endocrinol Metab. 2015 Jun;100(6):2291-302. doi: 10.1210/jc.2014-3868. Epub 2015 Mar 30.
PubMed 25822100Rynders CA, Morton SJ, Bessesen DH, Wright KP Jr, Broussard JL. Circadian Rhythm of Substrate Oxidation and Hormonal Regulators of Energy Balance. Obesity (Silver Spring). 2020 Jul;28 Suppl 1(Suppl 1):S104-S113. doi: 10.1002/oby.22816. Epub 2020 May 28.
PubMed 32463976
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Examine the Impact of Overfeeding on Peripheral Clock Gene Expression in Humans
- ClinicalTrials.gov ID
- NCT02809482
- Acronym / sponsor ID
- 15-1570
- Conditions
- Healthy
- Keywords
- Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Jun 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.
Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene expression in peripheral tissues resulting in a deleterious re-programming of the circadian metabolome. Studies in humans have only superficially investigated how the circadian clock machinery is impacted by nutritional signals. The overall goal of this pilot project is to take the first steps toward developing translational methods to investigate links between changes in energy flux and the circadian system in human tissues. Using an innovative ex vivo cell culture approach the investigators will examine the impact of 3-days of HF-OF compared to eucaloric (EU) feeding on the expression of core clock genes in human subcutaneous adipose tissue (SAT). The Investigators hypothesize that compared to EU, the amplitude of clock gene expression in SAT measured over 24hrs will be attenuated following short-term HF-OF. This pilot project will serve as a launch point for designing future studies into the effects of diet and exercise on the circadian control of metabolism in adipose tissue depots as well as other tissues (e.g. muscle).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eucaloric Feeding | Other | Other: Eucaloric feeding |
| Overfeeding | Other | Other: Overfeeding |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- males and females aged 20-35 yr;
- BMI 25-35 kg/m2 and weight stable (±2kg in past 2mo);
- non-smoker;
- sedentary to moderately active (≤3 days of exercise per week ≤30 min of exercise per session);
- sleeping pattern of >7 hours to 9.25 hrs of sleep/night.
Key exclusion criteria (16 listed)
- Smoker (current or within the previous 3 months);
- Use any medication that could affect lipid metabolism, insulin signaling, or sleep;
- Pregnant women will not be enrolled in the study;
- Have a job that involves shift work;
- Dwelling below Denver altitude (1,600 m) a year prior to testing;
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 |
|---|---|---|
| Eucaloric feeding3 days of a diet designed to maintain energy balance | Other | Eucaloric Feeding |
| Overfeeding3 days of a diet designed to induce a 40% positive energy balance | Other | Overfeeding |
Primary outcome
Expression of clock genes in adipose tissue.
Time frame: Measured through study completion, an average of 4 weeks.
Gene expression measured at two time points from abdominal fat.
2 secondary outcomes
Gene expression of key cellular fuel sensors thought to be controlled. and/or influenced by peripheral clocks
Time frame: Measured through study completion, an average of 4 weeks.
Expression of clock genes in blood monocytes.
Time frame: Measured through study completion, an average of 4 weeks.
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 1 Jul 2019.
- Background: PubMed 14963227Yoo SH, Yamazaki S, Lowrey PL, Shimomura K, Ko CH, Buhr ED, Siepka SM, Hong HK, Oh WJ, Yoo OJ, Menaker M, Takahashi JS. PERIOD2::LUCIFERASE real-time reporting of circadian dynamics reveals persistent circadian oscillations in mouse peripheral tissues. Proc Natl Acad Sci U S A. 2004 Apr 13;101(15):5339-46. doi: 10.1073/pnas.0308709101. Epub 2004 Feb 12.
- Background: PubMed 25519730Oosterman JE, Kalsbeek A, la Fleur SE, Belsham DD. Impact of nutrients on circadian rhythmicity. Am J Physiol Regul Integr Comp Physiol. 2015 Mar 1;308(5):R337-50. doi: 10.1152/ajpregu.00322.2014. Epub 2014 Dec 17.
- Background: PubMed 24360271Eckel-Mahan KL, Patel VR, de Mateo S, Orozco-Solis R, Ceglia NJ, Sahar S, Dilag-Penilla SA, Dyar KA, Baldi P, Sassone-Corsi P. Reprogramming of the circadian clock by nutritional challenge. Cell. 2013 Dec 19;155(7):1464-78. doi: 10.1016/j.cell.2013.11.034.
- Background: PubMed 25822100Pivovarova O, Jurchott K, Rudovich N, Hornemann S, Ye L, Mockel S, Murahovschi V, Kessler K, Seltmann AC, Maser-Gluth C, Mazuch J, Kruse M, Busjahn A, Kramer A, Pfeiffer AF. Changes of Dietary Fat and Carbohydrate Content Alter Central and Peripheral Clock in Humans. J Clin Endocrinol Metab. 2015 Jun;100(6):2291-302. doi: 10.1210/jc.2014-3868. Epub 2015 Mar 30.
- Derived from this study: PubMed 32463976Rynders CA, Morton SJ, Bessesen DH, Wright KP Jr, Broussard JL. Circadian Rhythm of Substrate Oxidation and Hormonal Regulators of Energy Balance. Obesity (Silver Spring). 2020 Jul;28 Suppl 1(Suppl 1):S104-S113. doi: 10.1002/oby.22816. Epub 2020 May 28.
- 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.
Daniel Bessesen, MD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eucaloric feeding and Overfeeding in people with Healthy, run by University of Colorado, Denver 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 16 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 1 Jul 2019. 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?
Expression of clock genes in adipose tissue. (time frame: Measured through study completion, an average of 4 weeks.). 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 NCT02809482, which also lists 5 linked publications.
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 1 Jul 2019.