Clinical trial NCT03569852: Time Restricted Feeding in Male Runners
Official title: The Effects of Four Weeks of Intermittent Fasting on Resting Energy Expenditure, Satiety Hormones, Body Composition, and Performance in Competitive Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Intermittent Fasting
Athletic Performance
Cardiovascular Risk Factor
Resting Energy Expenditure
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: University of California, Davis
First posted: 2018-06-26
Enrollment: 21
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in resting energy expenditure
timeFrame: Study day 1, 28, 43 and 70
Secondary outcomes:
measure: Change in body composition
timeFrame: Study day 1, 28, 43 and 70
measure: Change in substrate utilization during exercise
timeFrame: Study day 1, 28, 43 and 70
measure: Change in cardiovascular fitness
timeFrame: Study day 1, 28, 43 and 70
measure: Change in perceived feelings of hunger and fullness
timeFrame: Study day 1, 28, 43 and 70
measure: Change in glucagon, a biomarker of hunger and satiety
timeFrame: Study day 1, 28, 43 and 70
measure: Change in leptin, a biomarker of hunger and satiety
timeFrame: Study day 1, 28, 43 and 70
measure: Change in ghrelin, a biomarker of hunger and satiety
timeFrame: Study day 1, 28, 43 and 70
measure: Change in insulin
timeFrame: Study day 1, 28, 43 and 70
measure: Change in total cholesterol, a biomarker of cardiovascular health
timeFrame: Study day 1, 28, 43 and 70
measure: Change in HDL cholesterol, a biomarker of cardiovascular health
timeFrame: Study day 1, 28, 43 and 70
measure: Change in LDL cholesterol, a biomarker of cardiovascular health
timeFrame: Study day 1, 28, 43 and 70
measure: Change in very low-density lipoprotein (VLDL), a biomarker of cardiovascular health
timeFrame: Study day 1, 28, 43 and 70
measure: Change in triglycerides, a biomarker of cardiovascular health
timeFrame: Study day 1, 28, 43 and 70
measure: Change in alanine aminotransferase, a biomarker of cardiovascular health
timeFrame: Study day 1, 28, 43 and 70
measure: Change in aspartate aminotransferase, a biomarker of cardiovascular health
timeFrame: Study day 1, 28, 43 and 70
measure: Change in glucose
timeFrame: Study day 1, 28, 43 and 70
Other outcomes:
Locations:
city: Davis
country: United States
facility: UC Davis, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: University of California, Davis
name: Gretchen Casazza, PhD
role: PRINCIPAL_INVESTIGATOR
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