FastingNCT03569852
Time Restricted Feeding in Male Runners
A study testing Time Restrictive Feeding and Traditional Eating Pattern in people with Fasting and Intermittent Fasting, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
This is a cross-over intervention study designed to evaluate how four weeks of time restricted feeding (16 hours fasting and 8 hours feeding), compared to four weeks of a more traditional eating pattern (12 hours fasting and 12 hours feeding), affects resting energy expenditure, subjective and biochemical markers of… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting, Intermittent Fasting, Athletic Performance
- What is being tested?
- Time Restrictive Feeding and Traditional Eating Pattern
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 24 Mar 2020
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Competitive runners who have been actively training for 3 or more years
- Weigh a minimum of 110 lbs
- Training 4-6 times per week and run a minimum of 20 miles per week
- Competed in a race within past 12 months at a distance of 5 - 26.1 km
- Willing to repeat same monthly training protocol during two 4-week interventions
- VO2max range of 40-70 ml/kg/min
Who cannot join
- Smoker
- Take medications that have cardiovascular or metabolic effects
- Taking dietary supplements
- Following a restrictive diet including restricting calories or carbohydrates
- Evidence of an eating disorder
- Major injuries in past 3 months
- Chronic disease that affects bone health, metabolism or the cardiorespiratory system
- Present with any contra-indication to exercise testing (cardiovascular abnormalities) as evaluated by study physician
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis, Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: The Effects of Four Weeks of Intermittent Fasting on Resting Energy Expenditure, Satiety Hormones, Body Composition, and Performance in Competitive Runners
This is a cross-over intervention study designed to evaluate how four weeks of time restricted feeding (16 hours fasting and 8 hours feeding), compared to four weeks of a more traditional eating pattern (12 hours fasting and 12 hours feeding), affects resting energy expenditure, subjective and biochemical markers of satiety and hunger, body composition, cardiovascular health, substrate utilization and fitness in male competitive runners.
Read the detailed description
Weight loss and improvements in body composition (increasing muscle mass and decreasing fat mass) are common goals for both dieters and athletes. Although a traditional method of achieving this has been accomplished through caloric restriction, an alternate method that is becoming increasingly popular is fasting. Fasting is described as the absence of food and/or calorie-containing beverage consumption for a period of time. The majority of people fast for 8-10 hours daily, which occurs during the overnight period when people are asleep Intermittent fasting, specifically time-restricted feeding (TRF), has recently gained popularity because it is a more sustainable means of practicing fasting and it has been shown to enhance the loss of fat mass with or without caloric restriction. It has also been shown to enhance overall health due to reports of reduced fasting glucose, insulin resistance, triglycerides, and reduced total and low-density lipoprotein (LDL) cholesterol levels in obese women. Despite its growing popularity among athletes, there is scarce research on how adhering to this type of diet pattern affects athletic performance and other biochemical markers related to health. The participants in this study will be randomly assigned to either a traditional (12/12) or a time restrictive (16/8) eating pattern in a crossover design. Each pattern will last for four weeks with a minimum two week washout in between, and the participants will consume the same calorie and macronutrient amounts based on recommendations made by the American College of Sports Medicine (ACSM) for both eating patterns. The 12/12 pattern will require subjects to consume 5 meals (breakfast, lunch, dinner, and two snacks) per day within a 12 hour period suggested to be around 8am, 10am, 12pm, 3pm, and 7pm. The 16/8 pattern will require subjects to consume 3 meals in an 8-hour period suggested to be around 12pm, 3pm, and 7pm. Subjects may only consume water, unsweetened coffee, or unsweetened tea (no artificial sweeteners) during their periods of fasting. Subjects will perform all exercise in the morning before 8 am in the fasted state. Subjects will visit the Western Human Nutrition Research Center (WHNRC) for test days at baseline (study day 1), after four weeks of the first dietary intervention (study day 28), and at the start (study day 43) and end of the second dietary intervention (study day 70), for a total of 4 test days over the duration of 10 weeks.
- Conditions
- Fasting, Intermittent Fasting, Athletic Performance, Cardiovascular Risk Factor, Resting Energy Expenditure
- Being tested
- Time Restrictive Feeding, Traditional Eating Pattern
- Medical subject headings
- Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restrictive FeedingBehavioural
Also called Intermittent Fasting
Volunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day.
Traditional Eating PatternBehavioural
Also called Normal Diet
Volunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Order of treatment, time restrictive feeding (16 hours fasting and 8 hours eating) followed by traditional eating pattern (12 hours fasted and 12 hours eating). Receives: Behavioral: Time Restrictive Feeding; Behavioral: Traditional Eating Pattern |
| Experimental Group 2 | Experimental | Order of treatment, traditional eating pattern (12 hours fasted and 12 hours eating) followed by time restrictive feeding (16 hours fasting and 8 hours eating). Receives: Behavioral: Time Restrictive Feeding; Behavioral: Traditional Eating Pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting energy expenditure
Resting energy expenditure will be measured using a metabolic cart
Measured: Study day 1, 28, 43 and 70
Secondary outcomes (16)
Change in body composition
Body composition, including fat mass and lean body mass, will be measured by dual-energy x-ray absorptiometry (DEXA) and expressed in kilograms (kg).
Measured: Study day 1, 28, 43 and 70
Change in substrate utilization during exercise
Carbohydrate and fat utilized for energy will be measured using a metabolic cart
Measured: Study day 1, 28, 43 and 70
Change in cardiovascular fitness
Time to run a 10 kilometer time trial on a treadmill expressed in minutes
Measured: Study day 1, 28, 43 and 70
Change in perceived feelings of hunger and fullness
Perceived hunger and fullness will be measured using a visual analog scale. Responses will be a mark on an unsegmented line from 0 or "not at all" to 5 or "extremely."
Measured: Study day 1, 28, 43 and 70
Change in glucagon, a biomarker of hunger and satiety
Fasting plasma will be analyzed for glucagon (pmol/L) as measured by enzyme-linked immunoabsorbant assay
Measured: Study day 1, 28, 43 and 70
Change in leptin, a biomarker of hunger and satiety
Fasting plasma will be analyzed for leptin (pmol/L) as measured by enzyme-linked immunoabsorbant assay
Measured: Study day 1, 28, 43 and 70
Change in ghrelin, a biomarker of hunger and satiety
Fasting plasma will be analyzed for ghrelin (pmol/L) as measured by enzyme-linked immunoabsorbant assay
Measured: Study day 1, 28, 43 and 70
Change in insulin
Fasting plasma will be analyzed for insulin (pmol/L) as measured by enzyme-linked immunoabsorbant assay
Measured: Study day 1, 28, 43 and 70
Change in total cholesterol, a biomarker of cardiovascular health
Fasting serum will be analyzed for total cholesterol (mmol/L) by Piccolo analyzer
Measured: Study day 1, 28, 43 and 70
Change in HDL cholesterol, a biomarker of cardiovascular health
Fasting serum will be analyzed for HDL cholesterol (mmol/L) by Piccolo analyzer
Measured: Study day 1, 28, 43 and 70
Change in LDL cholesterol, a biomarker of cardiovascular health
Fasting serum will be analyzed for LDL cholesterol (mmol/L) by Piccolo analyzer
Measured: Study day 1, 28, 43 and 70
Change in very low-density lipoprotein (VLDL), a biomarker of cardiovascular health
Fasting serum will be analyzed for very low-density lipoprotein (VLDL) cholesterol (mmol/L) by Piccolo analyzer
Measured: Study day 1, 28, 43 and 70
Change in triglycerides, a biomarker of cardiovascular health
Fasting serum will be analyzed for triglycerides (mmol/L) by Piccolo analyzer
Measured: Study day 1, 28, 43 and 70
Change in alanine aminotransferase, a biomarker of cardiovascular health
Fasting serum will be analyzed for alanine aminotransferase (IU/L) by Piccolo analyzer
Measured: Study day 1, 28, 43 and 70
Change in aspartate aminotransferase, a biomarker of cardiovascular health
Fasting serum will be analyzed for aspartate aminotransferase (IU/L) by Piccolo analyzer
Measured: Study day 1, 28, 43 and 70
Change in glucose
Fasting serum will be analyzed for glucose (mmol/L) by Piccolo analyzer
Measured: Study day 1, 28, 43 and 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start15 Jul 2018
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for FastingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Gretchen Casazza, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569852
- Sponsor's protocol ID
- TRF 1223350
- Status last verified
- Mar 2020
- First submitted
- 15 Jun 2018
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maughan RJ, Fallah J, Coyle EF. The effects of fasting on metabolism and performance. Br J Sports Med. 2010 Jun;44(7):490-4. doi: 10.1136/bjsm.2010.072181. Epub 2010 May 19.
PubMed 20484315Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
PubMed 28715993Roy AS, Bandyopadhyay A. Effect of Ramadan intermittent fasting on selective fitness profile parameters in young untrained Muslim men. BMJ Open Sport Exerc Med. 2015 Sep 30;1(1):e000020. doi: 10.1136/bmjsem-2015-000020. eCollection 2015.
PubMed 27900122Tinsley GM, La Bounty PM. Effects of intermittent fasting on body composition and clinical health markers in humans. Nutr Rev. 2015 Oct;73(10):661-74. doi: 10.1093/nutrit/nuv041. Epub 2015 Sep 15.
PubMed 26374764Klempel MC, Kroeger CM, Bhutani S, Trepanowski JF, Varady KA. Intermittent fasting combined with calorie restriction is effective for weight loss and cardio-protection in obese women. Nutr J. 2012 Nov 21;11:98. doi: 10.1186/1475-2891-11-98.
PubMed 23171320Chaouachi A, Coutts AJ, Chamari K, Wong del P, Chaouachi M, Chtara M, Roky R, Amri M. Effect of Ramadan intermittent fasting on aerobic and anaerobic performance and perception of fatigue in male elite judo athletes. J Strength Cond Res. 2009 Dec;23(9):2702-9. doi: 10.1519/JSC.0b013e3181bc17fc.
PubMed 19910805Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.
PubMed 27737674Tinsley GM, Forsse JS, Butler NK, Paoli A, Bane AA, La Bounty PM, Morgan GB, Grandjean PW. Time-restricted feeding in young men performing resistance training: A randomized controlled trial. Eur J Sport Sci. 2017 Mar;17(2):200-207. doi: 10.1080/17461391.2016.1223173. Epub 2016 Aug 22.
PubMed 27550719Weigle DS, Duell PB, Connor WE, Steiner RA, Soules MR, Kuijper JL. Effect of fasting, refeeding, and dietary fat restriction on plasma leptin levels. J Clin Endocrinol Metab. 1997 Feb;82(2):561-5. doi: 10.1210/jcem.82.2.3757.
PubMed 9024254Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Four Weeks of Intermittent Fasting on Resting Energy Expenditure, Satiety Hormones, Body Composition, and Performance in Competitive Runners
- ClinicalTrials.gov ID
- NCT03569852
- Acronym / sponsor ID
- TRF 1223350
- Conditions
- Fasting, Intermittent Fasting, Athletic Performance, Cardiovascular Risk Factor, Resting Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- University of California, Davis
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- 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.
This is a cross-over intervention study designed to evaluate how four weeks of time restricted feeding (16 hours fasting and 8 hours feeding), compared to four weeks of a more traditional eating pattern (12 hours fasting and 12 hours feeding), affects resting energy expenditure, subjective and biochemical markers of satiety and hunger, body composition, cardiovascular health, substrate utilization and fitness in male competitive runners.
Detailed description
Weight loss and improvements in body composition (increasing muscle mass and decreasing fat mass) are common goals for both dieters and athletes. Although a traditional method of achieving this has been accomplished through caloric restriction, an alternate method that is becoming increasingly popular is fasting. Fasting is described as the absence of food and/or calorie-containing beverage consumption for a period of time. The majority of people fast for 8-10 hours daily, which occurs during the overnight period when people are asleep Intermittent fasting, specifically time-restricted feeding (TRF), has recently gained popularity because it is a more sustainable means of practicing fasting and it has been shown to enhance the loss of fat mass with or without caloric restriction. It has also been shown to enhance overall health due to reports of reduced fasting glucose, insulin resistance, triglycerides, and reduced total and low-density lipoprotein (LDL) cholesterol levels in obese women. Despite its growing popularity among athletes, there is scarce research on how adhering to this type of diet pattern affects athletic performance and other biochemical markers related to health. The participants in this study will be randomly assigned to either a traditional (12/12) or a time restrictive (16/8) eating pattern in a crossover design. Each pattern will last for four weeks with a minimum two week washout in between, and the participants will consume the same calorie and macronutrient amounts based on recommendations made by the American College of Sports Medicine (ACSM) for both eating patterns. The 12/12 pattern will require subjects to consume 5 meals (breakfast, lunch, dinner, and two snacks) per day within a 12 hour period suggested to be around 8am, 10am, 12pm, 3pm, and 7pm. The 16/8 pattern will require subjects to consume 3 meals in an 8-hour period suggested to be around 12pm, 3pm, and 7pm. Subjects may only consume water, unsweetened coffee, or unsweetened tea (no artificial sweeteners) during their periods of fasting. Subjects will perform all exercise in the morning before 8 am in the fasted state. Subjects will visit the Western Human Nutrition Research Center (WHNRC) for test days at baseline (study day 1), after four weeks of the first dietary intervention (study day 28), and at the start (study day 43) and end of the second dietary intervention (study day 70), for a total of 4 test days over the duration of 10 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Behavioral: Time Restrictive Feeding, Behavioral: Traditional Eating PatternOrder of treatment, time restrictive feeding (16 hours fasting and 8 hours eating) followed by traditional eating pattern (12 hours fasted and 12 hours eating). |
| Experimental Group 2 | Experimental | Behavioral: Time Restrictive Feeding, Behavioral: Traditional Eating PatternOrder of treatment, traditional eating pattern (12 hours fasted and 12 hours eating) followed by time restrictive feeding (16 hours fasting and 8 hours eating). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Competitive runners who have been actively training for 3 or more years
- Weigh a minimum of 110 lbs
- Training 4-6 times per week and run a minimum of 20 miles per week
- Competed in a race within past 12 months at a distance of 5 - 26.1 km
- Willing to repeat same monthly training protocol during two 4-week interventions
Key exclusion criteria (8 listed)
- Smoker
- Take medications that have cardiovascular or metabolic effects
- Taking dietary supplements
- Following a restrictive diet including restricting calories or carbohydrates
- Evidence of an eating disorder
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 |
|---|---|---|
| Time Restrictive FeedingAlso: Intermittent FastingVolunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day. | Behavioural | Experimental Group 1, Experimental Group 2 |
| Traditional Eating PatternAlso: Normal DietVolunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day. | Behavioural | Experimental Group 1, Experimental Group 2 |
Primary outcome
Change in resting energy expenditure
Time frame: Study day 1, 28, 43 and 70
Resting energy expenditure will be measured using a metabolic cart
16 secondary outcomes
Change in body composition
Time frame: Study day 1, 28, 43 and 70
Change in substrate utilization during exercise
Time frame: Study day 1, 28, 43 and 70
Change in cardiovascular fitness
Time frame: Study day 1, 28, 43 and 70
Change in perceived feelings of hunger and fullness
Time frame: Study day 1, 28, 43 and 70
Change in glucagon, a biomarker of hunger and satiety
Time frame: Study day 1, 28, 43 and 70
Change in leptin, a biomarker of hunger and satiety
Time frame: Study day 1, 28, 43 and 70
Change in ghrelin, a biomarker of hunger and satiety
Time frame: Study day 1, 28, 43 and 70
Change in insulin
Time frame: Study day 1, 28, 43 and 70
Change in total cholesterol, a biomarker of cardiovascular health
Time frame: Study day 1, 28, 43 and 70
Change in HDL cholesterol, a biomarker of cardiovascular health
Time frame: Study day 1, 28, 43 and 70
Change in LDL cholesterol, a biomarker of cardiovascular health
Time frame: Study day 1, 28, 43 and 70
Change in very low-density lipoprotein (VLDL), a biomarker of cardiovascular health
Time frame: Study day 1, 28, 43 and 70
Change in triglycerides, a biomarker of cardiovascular health
Time frame: Study day 1, 28, 43 and 70
Change in alanine aminotransferase, a biomarker of cardiovascular health
Time frame: Study day 1, 28, 43 and 70
Change in aspartate aminotransferase, a biomarker of cardiovascular health
Time frame: Study day 1, 28, 43 and 70
Change in glucose
Time frame: Study day 1, 28, 43 and 70
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 Apr 2020.
- Background: PubMed 20484315Maughan RJ, Fallah J, Coyle EF. The effects of fasting on metabolism and performance. Br J Sports Med. 2010 Jun;44(7):490-4. doi: 10.1136/bjsm.2010.072181. Epub 2010 May 19.
- Background: PubMed 28715993Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
- Background: PubMed 27900122Roy AS, Bandyopadhyay A. Effect of Ramadan intermittent fasting on selective fitness profile parameters in young untrained Muslim men. BMJ Open Sport Exerc Med. 2015 Sep 30;1(1):e000020. doi: 10.1136/bmjsem-2015-000020. eCollection 2015.
- Background: PubMed 26374764Tinsley GM, La Bounty PM. Effects of intermittent fasting on body composition and clinical health markers in humans. Nutr Rev. 2015 Oct;73(10):661-74. doi: 10.1093/nutrit/nuv041. Epub 2015 Sep 15.
- Background: PubMed 23171320Klempel MC, Kroeger CM, Bhutani S, Trepanowski JF, Varady KA. Intermittent fasting combined with calorie restriction is effective for weight loss and cardio-protection in obese women. Nutr J. 2012 Nov 21;11:98. doi: 10.1186/1475-2891-11-98.
- Background: PubMed 19910805Chaouachi A, Coutts AJ, Chamari K, Wong del P, Chaouachi M, Chtara M, Roky R, Amri M. Effect of Ramadan intermittent fasting on aerobic and anaerobic performance and perception of fatigue in male elite judo athletes. J Strength Cond Res. 2009 Dec;23(9):2702-9. doi: 10.1519/JSC.0b013e3181bc17fc.
- Background: PubMed 27737674Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.
- Background: PubMed 27550719Tinsley GM, Forsse JS, Butler NK, Paoli A, Bane AA, La Bounty PM, Morgan GB, Grandjean PW. Time-restricted feeding in young men performing resistance training: A randomized controlled trial. Eur J Sport Sci. 2017 Mar;17(2):200-207. doi: 10.1080/17461391.2016.1223173. Epub 2016 Aug 22.
- Background: PubMed 9024254Weigle DS, Duell PB, Connor WE, Steiner RA, Soules MR, Kuijper JL. Effect of fasting, refeeding, and dietary fat restriction on plasma leptin levels. J Clin Endocrinol Metab. 1997 Feb;82(2):561-5. doi: 10.1210/jcem.82.2.3757.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Gretchen Casazza, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restrictive Feeding and Traditional Eating Pattern in people with Fasting and Intermittent Fasting, run by USDA, Western Human Nutrition Research Center 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 1 Apr 2020. 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?
Change in resting energy expenditure (time frame: Study day 1, 28, 43 and 70). 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 NCT03569852, which also lists 10 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 Apr 2020.