Skip to main content
OpenTrials
Completed

NCT Number: NCT03569852

Time Restricted Feeding in Male 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis, Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time Restrictive Feeding

Behavioral

Volunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day.

Other names: Intermittent Fasting

Traditional Eating Pattern

Behavioral

Volunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day.

Other names: Normal Diet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • University of California, Davis

Registry information

Official study title

The Effects of Four Weeks of Intermittent Fasting on Resting Energy Expenditure, Satiety Hormones, Body Composition, and Performance in Competitive Runners

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2018
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.