Time to Eat Study - Pilot

NCT03590847 | Completed Results DMC

• 1 other identifier: IRB201801293
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population.

Conditions

Overweight

Keywords

Intermittent fasting; Inflammation; Diet; Lifestyle; Eating habits; Time Restricted Feeding

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability

  At each follow-up contact (either by phone or in person), participants are asked about any changes to their health or physical function since the previous contact. The changes are documented on the adverse event log.

  Week 4

• Adherence

  Adherence to the study intervention is measured using food intake time diary. Participants are considered compliant to the study intervention if he/she fasts between 14 - 18 hours per day for the duration of the 4 week study.

  Week 4

• Retention

  Number of Participants who dropped out before the Week 4 clinic visit was completed.

  Week 4

• Recruitment Yields

  Recruitment yields is measured by the number of individuals who were assessed at phone screening.

  Baseline

Secondary Outcomes (16)

• Body Weight

  Week 4

• Body Mass Index (BMI)

  Week 4

• Waist Circumference

  Week 4

• Blood Glucose

  Week 4

• Systolic Blood Pressure

  Week 4

Study Arms (1)

Intermittent fasting

EXPERIMENTAL

Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks.

Behavioral: Intermittent Fasting

Interventions

Intermittent Fasting BEHAVIORAL

Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Participants will be allowed to consume calorie-free beverages, water, tea, black coffee or sugar-free gum during the fasting period. Participants will be asked to record the time of first and final food/drink consumption each day.

Also known as: Time Restricted Feeding

Intermittent fasting

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Consent to participate in the study
• Men and women ≥ 65 years old
• Self-reported difficulty walking ¼ mile or climbing a flight of stairs
• Self-reported sedentariness (\<30 minutes structured exercise per week)
• Walking speed \<1 m/sec on the 4 m walk test
• Able to walk unassisted (cane allowed)
• Have a body mass index between 25 - 40 kg/m2 (inclusive)

You may not qualify if:

• Current dietary habits
• Fasting \>12 hours per day
• Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
• Weight loss \> 5 lbs in the past month
• Medical history or conditions
• Resting heart rate of \>120 beats per minute, systolic blood pressure \> 180 mmHg or diastolic blood pressure of \> 100 mmHg
• Unstable angina, heart attack or stroke in the past 3 months
• Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
• Rheumatoid arthritis, Parkinson's disease or currently on dialysis
• Active treatment for cancer in the past year
• Insulin dependent diabetes mellitus
• Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
• Any condition that in the opinion of the investigator would impair ability to participate in the trial

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Institute on Aging

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Overweight; Intermittent Fasting; Inflammation; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Behavior; Pathologic Processes; Behavior, Animal

Results Point of Contact

• Title: Dr. Stephen Anton
• Organization: University of Florida

santon@ufl.edu

(352) 273-7514

Study Officials

• Stephen Anton, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 18, 2018
• Study Start: June 28, 2018
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-12

Locations

US (1)