Pre DiabetesNCT04978376
TRE With Physical Activity for Weight Management
A study testing Time restricted eating in people with Pre Diabetes and Overweight and Obesity, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Pre Diabetes, Overweight and Obesity
- What is being tested?
- Time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Time Restricted Eating With Physical Activity for Weight Management
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.
Read the 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.
- Conditions
- Pre Diabetes, Overweight and Obesity
- Being tested
- Time restricted eating
- Keywords
- Intermittent Fasting
- Medical subject headings
- Glucose Intolerance, Overweight, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Also called resistance training, endurance exercise
We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating | Experimental | ad-libitum eating between 12:00-20:00 Receives: Behavioral: Time restricted eating |
| TRE with endurance training | Experimental | ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week Receives: Behavioral: Time restricted eating |
| TRE with resistance training | Experimental | ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week Receives: Behavioral: Time restricted eating |
| Control | No intervention | no change in diet or physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from week 1 to week 10
Secondary outcomes (3)
Body Composition Changes From Week 1 to Week 10
Change in lean mass from week 1 to week 10 by DEXA
Measured: Change from week 1 to week 10
Change in Insulin From Week 1 to Week 10
insulin will be measured by enzymatic kit (uIU/ml)^4
Measured: Change from week 1 to week 10
Glucose
measured by enzymatic kit (mg/dl)
Measured: Change from week 1 to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsey Nicole Dipman Gabel, University of Illinois at Chicago
- Investigators
- Kelsey Gabel, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978376
- Sponsor's protocol ID
- 2021-0575
- Status last verified
- Sep 2024
- First submitted
- 22 Jul 2021
- Last updated
- 18 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating With Physical Activity for Weight Management
- ClinicalTrials.gov ID
- NCT04978376
- Acronym / sponsor ID
- 2021-0575
- Conditions
- Pre Diabetes, Overweight and Obesity
- Keywords
- Intermittent Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 18 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Experimental | Behavioral: Time restricted eatingad-libitum eating between 12:00-20:00 |
| TRE with endurance training | Experimental | Behavioral: Time restricted eatingad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week |
| TRE with resistance training | Experimental | Behavioral: Time restricted eatingad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week |
| Control | No intervention | –no change in diet or physical activity |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingAlso: resistance training, endurance exerciseWe will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group. | Behavioural | TRE with endurance training, TRE with resistance training, Time restricted eating |
Primary outcome
Body Weight Changes Between Week 1 to Week 10
Time frame: 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).
3 secondary outcomes
Body Composition Changes From Week 1 to Week 10
Time frame: Change from week 1 to week 10
Change in Insulin From Week 1 to Week 10
Time frame: Change from week 1 to week 10
Glucose
Time frame: Change from week 1 to week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pre Diabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
RecruitingPhase 2
PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC
Lung Adenocarcinoma
RecruitingObservational study
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Diabetic Retinopathy, Diabetes Mellitus, Type 2
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelsey Gabel, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with Pre Diabetes and Overweight and Obesity, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight Changes Between Week 1 to Week 10 (time frame: Change from week 1 to week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.