Impact of Time Restricted Feeding on Daily Protein Requirements

University of Arkansas

Status: Completed

Conditions: Nutrition Disorders in Old Age

Treatments: Other: isocaloric, isonitrogenous meals

Study type: Interventional

Funder types: Other

Identifiers

NCT05610644

275081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 4 patient groups

TRF of RDA

Active Comparator group

Description:

A time-restricted model of consumption of the RDA of protein/day.

Treatment:

Other: isocaloric, isonitrogenous meals

TRAD of RDA

Active Comparator group

Description:

A typical American dietary ingestion pattern of the RDA of protein/day.

Treatment:

Other: isocaloric, isonitrogenous meals

TRF of 2RDA

Experimental group

Description:

A time-restricted model of consumption of twice the RDA of protein/day.

Treatment:

Other: isocaloric, isonitrogenous meals

TRAD of 2RDA

Experimental group

Description:

A typical American dietary ingestion pattern of twice the RDA of protein/day.

Treatment:

Other: isocaloric, isonitrogenous meals