Time Restricted Eating Plus Exercise for Weight Management

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05290233
Collaborator
(none)
40
1
2
11
3.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TRE + Exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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-diabetesA 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:
Single (Outcomes Assessor)
Masking Description:
blood sample analysis will be blinded
Primary Purpose:
Prevention
Official Title:
Time Restricted Eating Plus Exercise for Weight Management
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TRE+RT

Participants will confine eating between 12-8pm and fast from 8pm to 12pm daily combined with 3-4 days of supervised resistance 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

Active Comparator: TRE+AT

Participants will confine eating between 12-8pm and fast from 8pm to 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

Outcome Measures

Primary Outcome Measures

  1. Lean mass [change from week 1 to week 12]

    fat free mass will be measured via DXA

Secondary Outcome Measures

  1. body weight [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 [change kg of body weight from week 1 to week 12]

    fat mass will be measured via DXA

  3. Visceral fat mass [change kg of body weight from week 1 to week 12]

    visceral fat mass will be measured via DXA

  4. Insulin [change from week 1 to week 12]

    measured by enzymatic kit (uIU/ml)^4

  5. glucose [change from week 1 to week 12]

    measured by enzymatic kit (mg/dl)

  6. HbA1c [change from week 1 to week 12]

    measured by enzymatic kit (mmol/mol)

  7. Attention [Change from week 1 to week 12]

    National Institutes of Health Toolbox Cognition Battery

  8. executive function [Change from week 1 to week 12]

    National Institutes of Health Toolbox Cognition Battery

  9. processing speed [Change from week 1 to week 12]

    National Institutes of Health Toolbox Cognition Battery

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois at Chicago Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kelsey Nicole Dipman Gabel, Clinical Assistant Professor and Postdoctoral Researcher, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT05290233
Other Study ID Numbers:
  • 2022-0279
First Posted:
Mar 22, 2022
Last Update Posted:
Apr 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2022