An interventional study of TRE + Exercise in Intermittent Fasting, Pre Diabetes and Cognitive Decline, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Prevention
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.
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.
155 studies on the registry are indexed under Intermittent Fasting; 68 are open to participants now.
This study's enrollment of 36 is below the median of 58 across 151 interventional studies indexed under Intermittent Fasting.
Browse Intermittent Fasting studies →University of Illinois at Chicago is the lead sponsor of 523 studies on the registry; 132 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
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.
Behavioral: TRE + Exercise
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.
Behavioral: 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
Lean mass
fat free mass will be measured via DXA
Time frame: change from week 1 to week 12
body weight
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).
Time frame: change kg of body weight from week 1 to week 12
fat mass
fat mass will be measured via DXA
Time frame: change kg of body weight from week 1 to week 12
Visceral fat mass
visceral fat mass will be measured via DXA
Time frame: change kg of body weight from week 1 to week 12
Insulin
measured by enzymatic kit (uIU/ml)\^4
Time frame: change from week 1 to week 12
glucose
measured by enzymatic kit (mg/dl)
Time frame: change from week 1 to week 12
HbA1c
measured by enzymatic kit (mmol/mol)
Time frame: change from week 1 to week 12
Attention
National Institutes of Health Toolbox Cognition Battery
Time frame: Change from week 1 to week 12
executive function
National Institutes of Health Toolbox Cognition Battery
Time frame: Change from week 1 to week 12
processing speed
National Institutes of Health Toolbox Cognition Battery
Time frame: Change from week 1 to week 12
Plan to share: No
Ran from Sep 2023 to primary completion in Jul 2024, 9 months.
Of 127 non-industry interventional studies with no phase under Intermittent Fasting, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's 9 months is below that.
Counting every sponsor, half of 128 studies reached it within 20 months; a quarter within 11 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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