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Time Restricted Feeding in Male Runners

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569852
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center

Brief 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 satiety and hunger, body composition, cardiovascular health, substrate utilization and fitness in male competitive runners.

Condition or disease Intervention/treatment Phase
Fasting Intermittent Fasting Athletic Performance Cardiovascular Risk Factor Resting Energy Expenditure Behavioral: Time Restrictive Feeding Behavioral: Traditional Eating Pattern Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Four Weeks of Intermittent Fasting on Resting Energy Expenditure, Satiety Hormones, Body Composition, and Performance in Competitive Runners
Actual Study Start Date : July 15, 2018
Actual Primary Completion Date : March 24, 2020
Actual Study Completion Date : March 24, 2020

Arm Intervention/treatment
Experimental: Experimental Group 1
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).
Behavioral: Time Restrictive Feeding
Volunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day.
Other Name: Intermittent Fasting

Behavioral: Traditional Eating Pattern
Volunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day.
Other Name: Normal Diet

Experimental: Experimental Group 2
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).
Behavioral: Time Restrictive Feeding
Volunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day.
Other Name: Intermittent Fasting

Behavioral: Traditional Eating Pattern
Volunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day.
Other Name: Normal Diet




Primary Outcome Measures :
  1. Change in resting energy expenditure [ Time Frame: Study day 1, 28, 43 and 70 ]
    Resting energy expenditure will be measured using a metabolic cart


Secondary Outcome Measures :
  1. Change in body composition [ Time Frame: Study day 1, 28, 43 and 70 ]
    Body composition, including fat mass and lean body mass, will be measured by dual-energy x-ray absorptiometry (DEXA) and expressed in kilograms (kg).

  2. Change in substrate utilization during exercise [ Time Frame: Study day 1, 28, 43 and 70 ]
    Carbohydrate and fat utilized for energy will be measured using a metabolic cart

  3. Change in cardiovascular fitness [ Time Frame: Study day 1, 28, 43 and 70 ]
    Time to run a 10 kilometer time trial on a treadmill expressed in minutes

  4. Change in perceived feelings of hunger and fullness [ Time Frame: Study day 1, 28, 43 and 70 ]
    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."

  5. Change in glucagon, a biomarker of hunger and satiety [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting plasma will be analyzed for glucagon (pmol/L) as measured by enzyme-linked immunoabsorbant assay

  6. Change in leptin, a biomarker of hunger and satiety [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting plasma will be analyzed for leptin (pmol/L) as measured by enzyme-linked immunoabsorbant assay

  7. Change in ghrelin, a biomarker of hunger and satiety [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting plasma will be analyzed for ghrelin (pmol/L) as measured by enzyme-linked immunoabsorbant assay

  8. Change in insulin [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting plasma will be analyzed for insulin (pmol/L) as measured by enzyme-linked immunoabsorbant assay

  9. Change in total cholesterol, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting serum will be analyzed for total cholesterol (mmol/L) by Piccolo analyzer

  10. Change in HDL cholesterol, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting serum will be analyzed for HDL cholesterol (mmol/L) by Piccolo analyzer

  11. Change in LDL cholesterol, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting serum will be analyzed for LDL cholesterol (mmol/L) by Piccolo analyzer

  12. Change in very low-density lipoprotein (VLDL), a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting serum will be analyzed for very low-density lipoprotein (VLDL) cholesterol (mmol/L) by Piccolo analyzer

  13. Change in triglycerides, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting serum will be analyzed for triglycerides (mmol/L) by Piccolo analyzer

  14. Change in alanine aminotransferase, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting serum will be analyzed for alanine aminotransferase (IU/L) by Piccolo analyzer

  15. Change in aspartate aminotransferase, a biomarker of cardiovascular health [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting serum will be analyzed for aspartate aminotransferase (IU/L) by Piccolo analyzer

  16. Change in glucose [ Time Frame: Study day 1, 28, 43 and 70 ]
    Fasting serum will be analyzed for glucose (mmol/L) by Piccolo analyzer



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569852


Locations
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United States, California
UC Davis, Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
University of California, Davis
Investigators
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Principal Investigator: Gretchen Casazza, PhD University of California, Davis
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT03569852    
Other Study ID Numbers: TRF 1223350
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No