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Time Restricted Eating Plus Exercise for Weight Management

Time Restricted Eating Plus Exercise for Weight Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05290233
Enrollment
36
Registered
2022-03-22
Start date
2023-09-21
Completion date
2024-07-18
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Intermittent Fasting, Pre Diabetes

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.

Interventions

BEHAVIORALTRE + Exercise

We will compare the effects of TRE combined with resistance exercise versus TRE combined with aerobic training. Other Names: resistance training endurance exercise

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

blood sample analysis will be blinded

Intervention model description

A 12-week randomized, parallel-arm pilot trial will compare the effects of 1) TRE combined with resistance training (TRE-RT) to 2) TRE combined with aerobic training (TRE-AT) in older adults with overweight or obesity and pre-diabetes

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Lean masschange from week 1 to week 12fat free mass will be measured via DXA

Secondary

MeasureTime frameDescription
fat masschange kg of body weight from week 1 to week 12fat mass will be measured via DXA
Visceral fat masschange kg of body weight from week 1 to week 12visceral fat mass will be measured via DXA
Insulinchange from week 1 to week 12measured by enzymatic kit (uIU/ml)\^4
glucosechange from week 1 to week 12measured by enzymatic kit (mg/dl)
body weightchange kg of body weight from week 1 to week 12Body 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).
AttentionChange from week 1 to week 12National Institutes of Health Toolbox Cognition Battery
executive functionChange from week 1 to week 12National Institutes of Health Toolbox Cognition Battery
processing speedChange from week 1 to week 12National Institutes of Health Toolbox Cognition Battery
HbA1cchange from week 1 to week 12measured by enzymatic kit (mmol/mol)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026