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Completed

NCT Number: NCT05290233

Time Restricted Eating Plus Exercise for Weight Management

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

TRE + Exercise

Behavioral

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

Other Names:

resistance training endurance exercise

Primary outcomes

  1. Lean mass

    Time frame: change from week 1 to week 12

    fat free mass will be measured via DXA

Secondary outcomes

  1. body weight

    Time frame: change 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).

  2. fat mass

    Time frame: change kg of body weight from week 1 to week 12

    fat mass will be measured via DXA

  3. Visceral fat mass

    Time frame: change kg of body weight from week 1 to week 12

    visceral fat mass will be measured via DXA

  4. Insulin

    Time frame: change from week 1 to week 12

    measured by enzymatic kit (uIU/ml)^4

  5. glucose

    Time frame: change from week 1 to week 12

    measured by enzymatic kit (mg/dl)

  6. HbA1c

    Time frame: change from week 1 to week 12

    measured by enzymatic kit (mmol/mol)

  7. Attention

    Time frame: Change from week 1 to week 12

    National Institutes of Health Toolbox Cognition Battery

  8. executive function

    Time frame: Change from week 1 to week 12

    National Institutes of Health Toolbox Cognition Battery

  9. processing speed

    Time frame: Change from week 1 to week 12

    National Institutes of Health Toolbox Cognition Battery

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2022
Registry last updated
Sep 26, 2024

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.

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