Overweight and Obesity, Pre Diabetes
Conditions
Keywords
Intermittent Fasting
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.
Interventions
BEHAVIORALTime restricted eating
We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
Sponsors
University of Illinois at Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Changes Between Week 1 to Week 10 | Change from week 1 to week 10 | 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
| Measure | Time frame | Description |
|---|---|---|
| Body Composition Changes From Week 1 to Week 10 | Change from week 1 to week 10 | Change in lean mass from week 1 to week 10 by DEXA |
| Change in Insulin From Week 1 to Week 10 | Change from week 1 to week 10 | insulin will be measured by enzymatic kit (uIU/ml)\^4 |
| Glucose | Change from week 1 to week 10 | measured by enzymatic kit (mg/dl) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Time Restricted Eating ad-libitum eating between 12:00-20:00
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group. | 4 |
| TRE With Endurance Training ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group. | 4 |
| TRE With Resistance Training ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week
Time restricted eating: We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group. | 5 |
| Control no change in diet or physical activity | 4 |
| Total | 17 |
Baseline characteristics
| Characteristic | Time Restricted Eating | TRE With Endurance Training | TRE With Resistance Training | Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 15 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 4 | 61 years STANDARD_DEVIATION 6 | 57 years STANDARD_DEVIATION 6 | 52 years STANDARD_DEVIATION 5 | 57 years STANDARD_DEVIATION 5 |
| BMI | 36 kg/m^2 STANDARD_DEVIATION 4 | 34 kg/m^2 STANDARD_DEVIATION 3 | 36 kg/m^2 STANDARD_DEVIATION 4 | 35 kg/m^2 STANDARD_DEVIATION 5 | 35 kg/m^2 STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 5 Participants | 2 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 5 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 5 participants | 4 participants | 17 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Weight | 97 kilograms STANDARD_DEVIATION 10 | 98 kilograms STANDARD_DEVIATION 20 | 97 kilograms STANDARD_DEVIATION 13 | 89 kilograms STANDARD_DEVIATION 16 | 95 kilograms STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 |
Outcome results
Primary
Body Weight Changes Between Week 1 to Week 10
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Eating | Body Weight Changes Between Week 1 to Week 10 | -2.1 Percent body weight loss | Standard Error 0.8 |
| TRE With Endurance Training | Body Weight Changes Between Week 1 to Week 10 | -4.2 Percent body weight loss | Standard Error 0.8 |
| TRE With Resistance Training | Body Weight Changes Between Week 1 to Week 10 | -1.3 Percent body weight loss | Standard Error 1.1 |
| Control | Body Weight Changes Between Week 1 to Week 10 | .1 Percent body weight loss | Standard Error 0.5 |
Secondary
Body Composition Changes From Week 1 to Week 10
Change in lean mass from week 1 to week 10 by DEXA
Time frame: Change from week 1 to week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Eating | Body Composition Changes From Week 1 to Week 10 | -3.5 percent lean mass change | Standard Error 0.9 |
| TRE With Endurance Training | Body Composition Changes From Week 1 to Week 10 | -1.4 percent lean mass change | Standard Error 0.8 |
| TRE With Resistance Training | Body Composition Changes From Week 1 to Week 10 | .7 percent lean mass change | Standard Error 0.9 |
| Control | Body Composition Changes From Week 1 to Week 10 | -.3 percent lean mass change | Standard Error 5.1 |
Secondary
Change in Insulin From Week 1 to Week 10
insulin will be measured by enzymatic kit (uIU/ml)\^4
Time frame: Change from week 1 to week 10
Population: t-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Eating | Change in Insulin From Week 1 to Week 10 | -.9 (uIU/ml)^4 | Standard Error 0.1 |
| TRE With Endurance Training | Change in Insulin From Week 1 to Week 10 | .6 (uIU/ml)^4 | Standard Error 0.7 |
| TRE With Resistance Training | Change in Insulin From Week 1 to Week 10 | .3 (uIU/ml)^4 | Standard Error 2.5 |
| Control | Change in Insulin From Week 1 to Week 10 | 2 (uIU/ml)^4 | Standard Error 1.3 |
Secondary
Glucose
measured by enzymatic kit (mg/dl)
Time frame: Change from week 1 to week 10
Population: t-test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Eating | Glucose | -.5 mg/dl | Standard Deviation 2.2 |
| TRE With Endurance Training | Glucose | 1.5 mg/dl | Standard Deviation 10.5 |
| TRE With Resistance Training | Glucose | -5 mg/dl | Standard Deviation 1.8 |
| Control | Glucose | 1.7 mg/dl | Standard Deviation 8.8 |