Time Restricted Eating Plus Exercise for Weight Management

Cognitive Decline Clinical Trial

Official title:

Time Restricted Eating Plus Exercise for Weight Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05290233
• Other study ID #: 2022-0279
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Intermittent Fasting
• Pre Diabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean mass	fat free mass will be measured via DXA	change from week 1 to week 12
Secondary	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).	change kg of body weight from week 1 to week 12
Secondary	fat mass	fat mass will be measured via DXA	change kg of body weight from week 1 to week 12
Secondary	Visceral fat mass	visceral fat mass will be measured via DXA	change kg of body weight from week 1 to week 12
Secondary	Insulin	measured by enzymatic kit (uIU/ml)^4	change from week 1 to week 12
Secondary	glucose	measured by enzymatic kit (mg/dl)	change from week 1 to week 12
Secondary	HbA1c	measured by enzymatic kit (mmol/mol)	change from week 1 to week 12
Secondary	Attention	National Institutes of Health Toolbox Cognition Battery	Change from week 1 to week 12
Secondary	executive function	National Institutes of Health Toolbox Cognition Battery	Change from week 1 to week 12
Secondary	processing speed	National Institutes of Health Toolbox Cognition Battery	Change from week 1 to week 12