Time Restricted Eating Plus Exercise for Weight Management

NCT05290233 | Completed DMC

• 1 other identifier: 2022-0279
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting; Pre Diabetes; Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Lean mass

  fat free mass will be measured via DXA

  change from week 1 to week 12

Secondary Outcomes (9)

• body weight

  change kg of body weight from week 1 to week 12

• fat mass

  change kg of body weight from week 1 to week 12

• Visceral fat mass

  change kg of body weight from week 1 to week 12

• Insulin

  change from week 1 to week 12

• glucose

  change from week 1 to week 12

Study Arms (2)

TRE+RT

EXPERIMENTAL

Participants 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.

Behavioral: TRE + Exercise

TRE+AT

ACTIVE COMPARATOR

Participants 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.

Behavioral: TRE + Exercise

Interventions

TRE + Exercise BEHAVIORAL

We will compare the effects of TRE combined with resistance exercise versus TRE combined with aerobic training. Other Names: resistance training endurance exercise

TRE+AT; TRE+RT

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Intermittent Fasting; Glucose Intolerance; Cognitive Dysfunction

Interventions

Trehalase; Exercise

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Disaccharidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blood sample analysis will be blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor and Postdoctoral Researcher

Model Details: 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

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 22, 2022
• Study Start: September 21, 2023
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)