MedPath

Time Restricted Eating Plus Exercise for Weight Management

Not Applicable
Active, not recruiting
Conditions
Cognitive Decline
Intermittent Fasting
Pre Diabetes
Interventions
Behavioral: TRE + Exercise
Registration Number
NCT05290233
Lead Sponsor
University of Illinois at Chicago
Brief Summary

Time restricted eating (TRE) is currently the most popular form of intermittent fasting which involves confining the eating window to 8-10 hours (h) and fasting for the remaining hours of the day. TRE is unique in that during the eating window, individuals are not required to count calories or monitor food intake in any way, resulting in high adherence. Accumulating evidence suggests that TRE produces a natural energy deficit of \~350-500 kcal/d. Physical activity in combination with a healthy diet pattern is recommended for older adults. While aerobic type exercise is the most commonly recommended, retention of lean mass via resistance training, especially in older adults, may be more effective at improving mobility, neurological and psychological function, executive and cognitive functioning, and processing speed. TRE combined with physical activity has not been examined in older adults or in people with overweight or obesity. This study holds the potential to 1) decrease body weight 2) improve lean mass 3) improve insulin sensitivity, and 4) improve attention, executive functioning, and processing speed in older adults. The aims of this study will examine the effect of TRE combined with either resistance training or aerobic training on body weight, body composition, metabolic disease risk, and cognition in adults over age 50. It is hypothesized that the TRE combined with resistance training group will see the most significant improvements in body composition, insulin sensitivity and cognition due to lean mass accretion.

Detailed Description

Time restricted eating (TRE) is currently the most popular form of intermittent fasting which involves confining the eating window to 8-10 hours (h) and fasting for the remaining hours of the day. TRE is unique in that during the eating window, individuals are not required to count calories or monitor food intake in any way, resulting in high adherence. Accumulating evidence suggests that TRE produces a natural energy deficit of \~350-500 kcal/d. Physical activity in combination with a healthy diet pattern is recommended for older adults. While aerobic type exercise is the most commonly recommended, retention of lean mass via resistance training, especially in older adults, may be more effective at improving mobility, neurological and psychological function, executive and cognitive functioning, and processing speed. T TRE combined with physical activity has not been examined in older adults or in people with overweight or obesity. This study holds the potential to 1) decrease body weight 2) improve lean mass 3) improve insulin sensitivity, and 4) improve attention, executive functioning, and processing speed in older adults. This study will examine the effect of TRE combined with either resistance training or aerobic training on body weight, body composition, metabolic disease risk, and cognition in adults over age 50. It is hypothesized that the TRE combined with resistance training group will see the most significant improvements in body composition, insulin sensitivity and cognition due to lean mass accretion.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Adults with obesity (BMI between 30-50kg/m2)
  • pre-diabetes (fasting glucose: 100-125 mg/dl or HBA1c 5.7%-6.4% or OGTT ≥ 200 mg/dl)
  • sedentary or lightly active (<7,500 steps/day)
  • between the ages of 50-80 years
Exclusion Criteria
  • diagnosed with T1DM or T2DM (fasting glucose: >126 mg/dl, 2-h glucose OGTT ≥ 200 mg/dl,
  • HbA1c: >6.5%)
  • Individuals with a history of eating disorders
  • shift workers
  • Individuals taking drugs to control body weight and glucose (including metformin)
  • individuals who are not weight stable (weight gain or loss > 4 kg) 3 months prior to the intervention
  • mobility disorders or individuals unable to exercise for 40-60 minutes 3-4 days/week
  • Individuals diagnosed with comorbidities impacting cognition, including major/mild neurocognitive disorder, cerebrovascular disease (e.g., stroke, aneurysm, arteriovenous malformation), traumatic brain injury, epilepsy, or major psychiatric disorder (e.g., schizophrenia, bipolar disorder, substance use disorder)
  • Individuals who are unable to adequately report dietary intake or physical activity
  • Smokers

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TRE+ATTRE + ExerciseParticipants will confine eating between either 10am-6pm or 12-8pm and fast from 6pm-10am or 8pm-12pm daily combined with 3-4 days of supervised aerobic training per week.
TRE+RTTRE + ExerciseParticipants will confine eating between either 10am-6pm or 12-8pm and fast from 6pm-10am or 8pm-12pm daily combined with 3-4 days of supervised resistance training per week.
Primary Outcome Measures
NameTimeMethod
Lean masschange from week 1 to week 12

fat free mass will be measured via DXA

Secondary Outcome Measures
NameTimeMethod
glucosechange from week 1 to week 12

measured by enzymatic kit (mg/dl)

processing speedChange from week 1 to week 12

National Institutes of Health Toolbox Cognition Battery

body weightchange kg of body weight from week 1 to week 12

Body weight assessed to the nearest 0.25 kg every week without shoes and in light clothing using a balance beam scale (HealthOMeter, Boca Raton, FL).

fat masschange kg of body weight from week 1 to week 12

fat mass will be measured via DXA

Visceral fat masschange kg of body weight from week 1 to week 12

visceral fat mass will be measured via DXA

Insulinchange from week 1 to week 12

measured by enzymatic kit (uIU/ml)\^4

executive functionChange from week 1 to week 12

National Institutes of Health Toolbox Cognition Battery

AttentionChange from week 1 to week 12

National Institutes of Health Toolbox Cognition Battery

HbA1cchange from week 1 to week 12

measured by enzymatic kit (mmol/mol)

Trial Locations

Locations (1)

University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

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