ClinicalTrials.gg
RecruitingNCT07314658Updated Jan 2, 2026

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

An interventional study of TRE and ProtAM TRE in Generally Healthy Adults Over 60 Years Old, sponsored by University of Surrey. Recruiting at 1 site in United Kingdom. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by University of Surrey · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Generally Healthy Adults Over 60 Years Old
03

In context

Lead sponsor

University of Surrey is the lead sponsor of 91 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gender: male and female
  • Age range: 60 years or older
  • Fasting for 12 or less hours on a daily basis
  • 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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    TRE

    Participants undertaking the TRE intervention

    Other: TRE

  • Experimental
    ProtAM TRE

    Participants undertaking the ProtAM TRE intervention

    Other: ProtAM TRE

  • Experimental
    ProtPM TRE

    Participants undertaking the ProtPM TRE intervention

    Other: ProtPM TRE

  • No intervention
    Control

Interventions

  • OtherTRE

    * 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.

  • OtherProtAM 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).

    Also known as: TRE + morning protein 'snack'

  • OtherProtPM 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.

    Also known as: TRE + afternoon protein 'snack'

06

What researchers measure

Primary outcomes

  1. Change from baseline in body composition at 2 months using whole-body dual-energy x-ray absorptiometry (DEXA)

    Measured using whole-body dual-energy x-ray absorptiometry (DEXA) In addition to the above, body composition will also be assessed using Tanita Bioelectrical impedance analysis (BIA). Fat free and fat mass will be reported in kg.

    Time frame: For 8 weeks of the assigned study intervention

  2. Change from baseline in muscle function at 2 months

    Measured using grip strength

    Time frame: At the start and end of 8 weeks of the assigned study intervention

  3. Change from baseline in muscle function at 2 months

    Measured using 30-second sit-to-stand test.

    Time frame: At the start and end of 8 weeks of the assigned study intervention

Secondary outcomes

  1. Change in fasting glucose control indicators

    HbA1c

    Time frame: At the start and end of 8 weeks of the assigned study intervention

  2. Change from baseline in insulin sensitivity at 2 months

    HOMA-IR

    Time frame: At the start and end of 8 weeks of the assigned study intervention

  3. Change from baseline in lipid metabolism at 2 months

    fasting total, LDL- and HDL cholesterol and triglyerides

    Time frame: At the start and end of 8 weeks of the assigned study intervention

  4. Change from baseline in diet composition at 2 months

    Macro- and micronutrient analysis using the nutrition analysis platform Nutritics of 3-day food diaries administered at the start, mid-point and end of the assigned study intervention.

    Time frame: At the start, mid-point (week 4) and end of 8 weeks of the assigned study intervention

  5. Feasibility of the assigned TRE intervention

    semi-structured interviews

    Time frame: at the end of the 8 week intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Not required or applicable for this study protocol

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2025; primary completion for Jun 2027, 18 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2025
First posted
Jan 2, 2026
StartEst.
Dec 2025
Primary completionEst.
Jun 2027
CompletionEst.
Jul 2027
Last update
Jan 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07314658
Lead sponsor
University of Surrey
Responsible party
Sponsor
First posted
Jan 2, 2026
Start date
Dec 2025 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jan 2, 2026

Study contacts

Yana Petkova
Contact
yp00228@surrey.ac.uk
+44 7513 679 635
Dr Collins
Contact
a.collins@surrey.ac.uk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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