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Intermittent FastingNCT05290233

Time Restricted Eating Plus Exercise for Weight Management

A study testing TRE + Exercise in people with Intermittent Fasting and Pre Diabetes, run by University of Illinois at Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
What is being tested?
TRE + Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
21 Sep 2023to 18 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 50-80 years

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

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.

Read the 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.

Being tested
TRE + Exercise
Medical subject headings
Intermittent Fasting, Glucose Intolerance, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRE + ExerciseBehavioural

    We will compare the effects of TRE combined with resistance exercise versus TRE combined with aerobic training.

    Other Names:

    resistance training endurance exercise

Study groups in NCT05290233
Study groupRoleWhat they receive
TRE+RTExperimentalParticipants 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.
Receives: Behavioral: TRE + Exercise
TRE+ATActive comparatorParticipants 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.
Receives: Behavioral: TRE + Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lean mass

    fat free mass will be measured via DXA

    Measured: change from week 1 to week 12

Secondary outcomes (9)

  1. 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).

    Measured: change kg of body weight from week 1 to week 12

  2. fat mass

    fat mass will be measured via DXA

    Measured: change kg of body weight from week 1 to week 12

  3. Visceral fat mass

    visceral fat mass will be measured via DXA

    Measured: change kg of body weight from week 1 to week 12

  4. Insulin

    measured by enzymatic kit (uIU/ml)^4

    Measured: change from week 1 to week 12

  5. glucose

    measured by enzymatic kit (mg/dl)

    Measured: change from week 1 to week 12

  6. HbA1c

    measured by enzymatic kit (mmol/mol)

    Measured: change from week 1 to week 12

  7. Attention

    National Institutes of Health Toolbox Cognition Battery

    Measured: Change from week 1 to week 12

  8. executive function

    National Institutes of Health Toolbox Cognition Battery

    Measured: Change from week 1 to week 12

  9. processing speed

    National Institutes of Health Toolbox Cognition Battery

    Measured: Change from week 1 to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2022
  2. Study start21 Sep 2023
  3. Primary completion18 Jul 2024
  4. Study completion18 Jul 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05290233
Sponsor's protocol ID
2022-0279
Status last verified
Sep 2024
First submitted
11 Mar 2022
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sanchez Perez J, Czyzewski O, Hamm A, Fought-Boudaia A, Cares K, Motl RW, Gabel K. Feasibility and acceptability of 8-h time-restricted eating combined with aerobic or resistance training in older adults with prediabetes and obesity. Ann Behav Med. 2026 Jan 7;60(1):kaag060. doi: 10.1093/abm/kaag060.

    PubMed 42847405

Questions about this trial

What is this clinical trial studying?

A study testing TRE + Exercise in people with Intermittent Fasting and Pre Diabetes, 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 4 inclusion and 10 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 26 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Lean mass (time frame: change from week 1 to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05290233, which also lists 1 linked publication.

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 26 Sep 2024.

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