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Recruiting NCT07314658

Time-restricted Eating (TRE) and Protein in Older Adults

No phase Interventional Generally Healthy Adults Over 60 Years Old

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRE, ProtAM TRE, ProtPM TRE.
Who it may be relevant to
Registry conditions: Generally Healthy Adults Over 60 Years Old. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effects of Time-restricted Eating (TRE) With and Without Additional Protein on Body Composition, Muscle Function and Markers of Metabolic Health in Older Adults

Overview

The aim this study is to investigate the effects of time-restricted eating (TRE) on body composition, muscle function and markers of metabolic health of adults over 60 years old. This study will compare different variations of TRE - with and without an additional protein. This study involves attending two study days at the University of Surrey for baseline and end-of-intervention measurement of body composition using a gold-standard dual energy x-ray absorptiometry (DEXA) scan; muscle function using hand grip strength and 30-second sit-to-stand tests; weight. A blood sample will be taken at each study visit to measure markers of lipid and glucose control, and insulin sensitivity. Participants will be randomly allocated to one of four study groups: * control group: maintain habitual dietary patterns * TRE group: fast for 16 hours overnight, eat between 12-8pm * TRE + Protein (AM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the morning * TRE + Protein (PM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the afternoon Participants will be asked to follow the intervention according to their allocated group for 8 weeks.

Interventions

  • Other TRE
    * Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight. * Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea/coffee, 0-calorie soft drinks.
  • Other ProtAM TRE
    * Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight. * Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea/coffee, 0-calorie soft drinks. * In addition, they will be asked to consume a protein drink containing 30g protein in the morning, 2 hours before the 8-hour eating window opens at 12pm (i.e. at 10am).
  • Other ProtPM TRE
    * Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight. * Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea/coffee, 0-calorie soft drinks. * In addition, they will be asked to consume a protein drink containing 30g protein in the afternoon, either 2 hours after their first meal or 2 hours before their last meal of the day.

Primary outcome measures

  • Change from baseline in body composition at 2 months using whole-body dual-energy x-ray absorptiometry (DEXA) [Time frame: For 8 weeks of the assigned study intervention]
  • Change from baseline in muscle function at 2 months [Time frame: At the start and end of 8 weeks of the assigned study intervention]
  • Change from baseline in muscle function at 2 months [Time frame: At the start and end of 8 weeks of the assigned study intervention]
Secondary outcome measures (5)
  • Change in fasting glucose control indicators [Time frame: At the start and end of 8 weeks of the assigned study intervention]
  • Change from baseline in insulin sensitivity at 2 months [Time frame: At the start and end of 8 weeks of the assigned study intervention]
  • Change from baseline in lipid metabolism at 2 months [Time frame: At the start and end of 8 weeks of the assigned study intervention]
  • Change from baseline in diet composition at 2 months [Time frame: At the start, mid-point (week 4) and end of 8 weeks of the assigned study intervention]
  • Feasibility of the assigned TRE intervention [Time frame: at the end of the 8 week intervention]

Eligibility criteria

Inclusion criteria

  • Gender: male and female
  • Age range: 60 years or older
  • Fasting for 12 or less hours on a daily basis
  • BMI range: 23-30 kg/m2
  • Weight stability: no more than 3kg weight gain or loss in the past 3 months
  • Regular eating pattern, i.e. 3 meals a day
  • Able to prepare the protein supplement

Exclusion criteria

  • Any of the following present (in line with exclusion criteria used in previous TRE research in older adults):
  • known renal impairment
  • heart attack or stroke in the past three months
  • continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
  • rheumatoid arthritis
  • Parkinson's disease
  • active treatment for cancer in the past year
  • insulin dependent diabetes mellitus
  • taking medications that preclude fasting for 16 h
  • actively trying or planning to lose weight
  • history of an eating disorder
  • outside of stated age or BMI range
  • fasting for longer than 12 hours on a daily basis
  • unable to prepare the protein supplement
  • extreme morning/evening chronotype
  • sleep disorders
  • regular meal skipping
  • history of difficulty having a blood sample taken
  • Recent exposure to high-dose radiation
  • Vigorous exercise on more than 3 occasions a week

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • University of Surrey — Guildford

Identifiers

NCT: NCT07314658 · 361019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗