Impact of Time Restricted Feeding on Daily Protein Requirements

Nutrition Disorders in Old Age Clinical Trial

Official title:

Impact of Time Restricted Feeding on Daily Protein Requirements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05610644
• Other study ID #: 275081
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: University of Arkansas
• Contact: David Church
• Phone: 501-526-5769
• Email: dchurch[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults.

Description:

The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults. Individuals in the TRF pattern will only consume food during a 6-hour eating period and fast for the remaining 18 hours. Individuals in the TRAD pattern will consume isocaloric and isonitrogenous (RDA or 2RDA) diet but consume an all-beef-breakfast. Participants will consume oral stable isotopes to measure muscle protein synthesis (MPS), whole-body muscle protein breakdown (MPB), and whole-body protein balance (WBPB). Appropriate muscle, blood samples, and urine will be collected throughout a 24-hour metabolic trial following a 2-day controlled diet.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Men and women ages 50-75 years.

2. BMI 20-30 kg/m2 inclusive.

3. Capable of providing informed consent.

4. COVID-19 negative and/or asymptomatic

Exclusion Criteria:

1. Subject who does not/will not eat animal protein sources.

2. Body mass index <20 or >30.

3. Hemoglobin <10g/dL at screening.

4. Platelets <150,000/uL at screening.

5. History of diabetes.

6. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.

7. History of gastrointestinal bypass/reduction surgery.

8. History of a chronic inflammatory disease (e.g. what?)

9. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.

10. Currently using prescription blood thinning medications.

11. Currently using corticosteroid medications.

12. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.

13. Unwilling to avoid using protein or amino-acid supplements during participation.

14. Subjects who are unwilling to fast overnight.

15. Participating in >200 minutes/week of vigorous exercise and/or >4 days/week of resistance training.

Related Conditions & MeSH terms

• Nutrition Disorders
• Nutrition Disorders in Old Age

Intervention

Other:
• isocaloric, isonitrogenous meals
Participants will eat prepared study meals for 3 days that have either the RDA of protein per day or twice the RDA of protein per day.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole-body protein balance	Volume of net protein produced per unit of time	24 hours