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Time Restricted Eating Plus Exercise for Weight Management

Primary Purpose

Intermittent Fasting, Pre Diabetes, Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRE + Exercise
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intermittent Fasting

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Overweight and obese adults (BMI between 25-50kg/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 50-85 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

Sites / Locations

  • University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRE+RT

TRE+AT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Lean mass
fat free mass will be measured via DXA

Secondary Outcome Measures

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).
fat mass
fat mass will be measured via DXA
Visceral fat mass
visceral fat mass will be measured via DXA
Insulin
measured by enzymatic kit (uIU/ml)^4
glucose
measured by enzymatic kit (mg/dl)
HbA1c
measured by enzymatic kit (mmol/mol)
Attention
National Institutes of Health Toolbox Cognition Battery
executive function
National Institutes of Health Toolbox Cognition Battery
processing speed
National Institutes of Health Toolbox Cognition Battery

Full Information

First Posted
March 11, 2022
Last Updated
April 10, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05290233
Brief Title
Time Restricted Eating Plus Exercise for Weight Management
Official Title
Time Restricted Eating Plus Exercise for Weight Management
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Anticipated)
Primary Completion Date
January 2, 2024 (Anticipated)
Study Completion Date
January 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Fasting, Pre Diabetes, Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Outcomes Assessor
Masking Description
blood sample analysis will be blinded
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRE+RT
Arm Type
Experimental
Arm Description
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.
Arm Title
TRE+AT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TRE + Exercise
Intervention Description
We will compare the effects of TRE combined with resistance exercise versus TRE combined with aerobic training. Other Names: resistance training endurance exercise
Primary Outcome Measure Information:
Title
Lean mass
Description
fat free mass will be measured via DXA
Time Frame
change from week 1 to week 12
Secondary Outcome Measure Information:
Title
body weight
Description
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
Title
fat mass
Description
fat mass will be measured via DXA
Time Frame
change kg of body weight from week 1 to week 12
Title
Visceral fat mass
Description
visceral fat mass will be measured via DXA
Time Frame
change kg of body weight from week 1 to week 12
Title
Insulin
Description
measured by enzymatic kit (uIU/ml)^4
Time Frame
change from week 1 to week 12
Title
glucose
Description
measured by enzymatic kit (mg/dl)
Time Frame
change from week 1 to week 12
Title
HbA1c
Description
measured by enzymatic kit (mmol/mol)
Time Frame
change from week 1 to week 12
Title
Attention
Description
National Institutes of Health Toolbox Cognition Battery
Time Frame
Change from week 1 to week 12
Title
executive function
Description
National Institutes of Health Toolbox Cognition Battery
Time Frame
Change from week 1 to week 12
Title
processing speed
Description
National Institutes of Health Toolbox Cognition Battery
Time Frame
Change from week 1 to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 50-85 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
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Gabel, PhD
Phone
312-413-8911
Email
kdipma2@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Time Restricted Eating Plus Exercise for Weight Management

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