Time Restricted Eating Plus Exercise for Weight Management

NCT ID: NCT05290233

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2024-07-18

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.

Conditions

Intermittent Fasting; Pre Diabetes; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TRE+RT

Participants 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.

Group Type: EXPERIMENTAL

TRE + Exercise

Intervention Type: BEHAVIORAL

We will compare the effects of TRE combined with resistance exercise versus TRE combined with aerobic training.

Other Names:

resistance training endurance exercise

TRE+AT

Participants 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.

Group Type: ACTIVE_COMPARATOR

TRE + Exercise

Intervention Type: BEHAVIORAL

We will compare the effects of TRE combined with resistance exercise versus TRE combined with aerobic training.

Other Names:

resistance training endurance exercise

Interventions

TRE + Exercise

We will compare the effects of TRE combined with resistance exercise versus TRE combined with aerobic training.

Other Names:

resistance training endurance exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Kelsey Nicole Dipman Gabel

Clinical Assistant Professor and Postdoctoral Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2022-0279

Identifier Type: -

Identifier Source: org_study_id