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TRE With Physical Activity for Weight Management

Primary Purpose

Pre Diabetes, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restricted eating
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre Diabetes focused on measuring Intermittent Fasting

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 50 to 70 years old
  • BMI between 25 and 50 kg/m2
  • Pre-diabetic or insulin resistant (fasting glucose: 100-125 mg/dl, HBA1c 5.7%-6.4%, or HOMA-IR >2.5)
  • Sedentary or lightly active 24
  • Are post menopausal (absence of menstrual cycle for 1 year)

Exclusion Criteria:

  • Diabetic (fasting glucose: >126 mg/dl or HBA1c >6.5%)
  • Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
  • Have uncontrolled hypertension, any other cardiovascular disease, or history of aneurysm
  • History of alcohol dependance (score >20 from Alcohol and Health Questionnaire)25
  • Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg)
  • Are not able to keep a food diary or activity log for 7 consecutive days during screening
  • Are taking drugs that influence study outcomes (weight loss, glucose-lowering medications)
  • Are premenopausal, perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
  • Mobility disability (unable to exercise for 40-60 minutes 3-5 days/week)
  • Diagnosed comorbidities including systemic diseases (Parkinson's cirrhosis, renal disease or systemic rheumatic conditions), cancer, or cognitive impairment
  • Are night shift workers
  • Are smokers

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Time restricted eating

TRE with endurance training

TRE with resistance training

Control

Arm Description

ad-libitum eating between 12:00-20:00

ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week

ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week

no change in diet or physical activity

Outcomes

Primary 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).

Secondary Outcome Measures

Body composition
fat free mass and fat mass via DXA
Insulin
measured by enzymatic kit (uIU/ml)^4
Glucose
measured by enzymatic kit (mg/dl)
HbA1c
measured by enzymatic kit (mmol/mol)

Full Information

First Posted
July 22, 2021
Last Updated
April 10, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04978376
Brief Title
TRE With Physical Activity for Weight Management
Official Title
Time Restricted Eating With Physical Activity for Weight Management
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

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
No

5. Study Description

Brief Summary
Approximately 24 million older adults have prediabetes. Obesity, age related decreases in lean mass and increases in fat mass, and sedentary lifestyle have been associated with functional and cognitive decline in older adults. Innovative lifestyle strategies to treat obesity and pre-diabetes are critically needed. The proposed research will demonstrate that time restricted eating combined with resistance training is an effective non-pharmacological therapy to help obese prediabetic individuals reduce body fat, maintain lean mass, prevent progression of prediabetes to diabetes, and improve cognition.
Detailed Description
Obesity, age related decreases in lean mass and increases in fat mass, and sedentary lifestyle have been associated with functional and cognitive decline in older adults. It is expected that the proportion of the population of over 65 will continue to increase as will the number of older adults with pre-diabetes. Treatment of pre-diabetes and improved functionality and cognition in older adults include maintaining a healthy weight and regular exercise. While daily calorie restriction is the most common prescription for weight loss, intermittent fasting is an alternative to daily calorie restriction producing significant weight loss. Currently, the most popular form of intermittent fasting is time restricted eating (TRE). TRE typically involves confining the eating window to 6-10 h and fasting for the remaining hours of the day. During the eating window, individuals are not required to count calories or monitor food intake in any way. Current TRE data shows promising results for diet alone including natural calorie restriction, weight loss, decreased blood pressure and increased insulin sensitivity all while maintaining a high adherence. To our knowledge, TRE combined with resistance training (RT) or endurance training (EN)has only been examined in lean resistance trained young adults, never in older adults or adults with overweight or obesity. Hypothesis: The present proposal will test the following hypothesis: (1) Both combination groups will lose significantly more weight than TRE alone or the control. The TRE + RT group will significantly decrease fat mass and increase lean mass more than the TRE + EN, TRE alone or control group. The TRE + RT will lose the same amount of body weight but maintain more lean mass than the TRE+EN group; (2a) The TRE+RT group will experience greater improvements in insulin sensitivity, insulin resistance, HbA1c and other metabolic disease variables (fasting insulin, triglycerides, LDL cholesterol, and blood pressure) versus the TRE+EN group after the 8-week trial due to reductions in body weight and greater retention of lean mass; (2b) TRE combined with both EN and RT will be safe in older adults with no significant intervention related adverse events; (3) TRE combined with both EN and RT will improve attention and executive function and working memory in the physical activity groups more than diet alone or the control group. Methods: To test these objectives, a 10-week parallel-arm pilot trial will be implemented. Older adults with overweight or obesity and pre-diabetes will be assigned to one of four groups: (1) TRE group, ad-libitum eating between 12:00-20:00 (n=50) (2) TRE + EN ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week (n=50) (3)TRE + RT group, ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week (n=50) or (4) Control group, no change in diet or physical activity (n=50). Significance: If the aims of this application are achieved, this study will be the first to show that TRE with physical activity is safe in older adults and can be implemented as an alternative to traditional dieting (i.e. daily calorie restriction) for weight management and lean mass retention. This study will also show that TRE can be used as an effective non-pharmacological therapy to improve insulin sensitivity, decrease metabolic risk factors, and improve cognition in older individuals with obesity and pre-diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Overweight and Obesity
Keywords
Intermittent Fasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time restricted eating
Arm Type
Experimental
Arm Description
ad-libitum eating between 12:00-20:00
Arm Title
TRE with endurance training
Arm Type
Experimental
Arm Description
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week
Arm Title
TRE with resistance training
Arm Type
Experimental
Arm Description
ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week
Arm Title
Control
Arm Type
No Intervention
Arm Description
no change in diet or physical activity
Intervention Type
Behavioral
Intervention Name(s)
Time restricted eating
Other Intervention Name(s)
resistance training, endurance exercise
Intervention Description
We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
Primary 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 from week 1 to week 10
Secondary Outcome Measure Information:
Title
Body composition
Description
fat free mass and fat mass via DXA
Time Frame
Change from week 1 to week 10
Title
Insulin
Description
measured by enzymatic kit (uIU/ml)^4
Time Frame
Change from week 1 to week 10
Title
Glucose
Description
measured by enzymatic kit (mg/dl)
Time Frame
Change from week 1 to week 10
Title
HbA1c
Description
measured by enzymatic kit (mmol/mol)
Time Frame
Change from week 1 to week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 50 to 70 years old BMI between 25 and 50 kg/m2 Pre-diabetic or insulin resistant (fasting glucose: 100-125 mg/dl, HBA1c 5.7%-6.4%, or HOMA-IR >2.5) Sedentary or lightly active 24 Are post menopausal (absence of menstrual cycle for 1 year) Exclusion Criteria: Diabetic (fasting glucose: >126 mg/dl or HBA1c >6.5%) Have a history of eating disorders (anorexia, bulimia, or binge eating disorder) Have uncontrolled hypertension, any other cardiovascular disease, or history of aneurysm History of alcohol dependance (score >20 from Alcohol and Health Questionnaire)25 Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg) Are not able to keep a food diary or activity log for 7 consecutive days during screening Are taking drugs that influence study outcomes (weight loss, glucose-lowering medications) Are premenopausal, perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days) Mobility disability (unable to exercise for 40-60 minutes 3-5 days/week) Diagnosed comorbidities including systemic diseases (Parkinson's cirrhosis, renal disease or systemic rheumatic conditions), cancer, or cognitive impairment Are night shift workers Are smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelsey Gabel, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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TRE With Physical Activity for Weight Management

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