Generally Healthy Adults Over 60 Years OldNCT07314658
Time-restricted Eating (TRE) and Protein in Older Adults
A study testing TRE, ProtAM TRE and ProtPM TRE in people with Generally Healthy Adults Over 60 Years Old, run by University of Surrey at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Generally Healthy Adults Over 60 Years Old
- What is being tested?
- TRE, ProtAM TRE and ProtPM TRE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Collins contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Surrey
Guildford, GU2 7XH
Yana Petkova, +44 7513 679 635, yp00228@surrey.ac.uk
Dr Collins, a.collins@surrey.ac.uk
About this study
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
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.
Read more
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.
- Being tested
- TRE, ProtAM TRE, ProtPM TRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREOther
- 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.
ProtAM TREOther
Also called TRE + morning protein 'snack'
- 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).
ProtPM TREOther
Also called TRE + afternoon protein 'snack'
- 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.
| Study group | Role | What they receive |
|---|---|---|
| TRE | Experimental | Participants undertaking the TRE intervention Receives: Other: TRE |
| ProtAM TRE | Experimental | Participants undertaking the ProtAM TRE intervention Receives: Other: ProtAM TRE |
| ProtPM TRE | Experimental | Participants undertaking the ProtPM TRE intervention Receives: Other: ProtPM TRE |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 8 weeks of the assigned study intervention
Change from baseline in muscle function at 2 months
Measured using grip strength
Measured: At the start and end of 8 weeks of the assigned study intervention
Change from baseline in muscle function at 2 months
Measured using 30-second sit-to-stand test.
Measured: At the start and end of 8 weeks of the assigned study intervention
Secondary outcomes (5)
Change in fasting glucose control indicators
HbA1c
Measured: At the start and end of 8 weeks of the assigned study intervention
Change from baseline in insulin sensitivity at 2 months
HOMA-IR
Measured: At the start and end of 8 weeks of the assigned study intervention
Change from baseline in lipid metabolism at 2 months
fasting total, LDL- and HDL cholesterol and triglyerides
Measured: At the start and end of 8 weeks of the assigned study intervention
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.
Measured: At the start, mid-point (week 4) and end of 8 weeks of the assigned study intervention
Feasibility of the assigned TRE intervention
semi-structured interviews
Measured: at the end of the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study startDec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generally Healthy Adults Over 60 Years OldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314658
- Sponsor's protocol ID
- 361019
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not required or applicable for this study protocol
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07314658
- Acronym / sponsor ID
- 361019
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TRE | Experimental | Other: TREParticipants undertaking the TRE intervention |
| ProtAM TRE | Experimental | Other: ProtAM TREParticipants undertaking the ProtAM TRE intervention |
| ProtPM TRE | Experimental | Other: ProtPM TREParticipants undertaking the ProtPM TRE intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- Any of the following present (in line with exclusion criteria used in previous TRE research in older adults):
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | TRE |
| ProtAM TREAlso: TRE + morning protein 'snack'* 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 | ProtAM TRE |
| ProtPM TREAlso: TRE + afternoon protein 'snack'* 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. | Other | ProtPM TRE |
Primary outcome
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
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.
Change from baseline in muscle function at 2 months
Time frame: At the start and end of 8 weeks of the assigned study intervention
Measured using grip strength
Change from baseline in muscle function at 2 months
Time frame: At the start and end of 8 weeks of the assigned study intervention
Measured using 30-second sit-to-stand test.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No. Not required or applicable for this study protocol
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Collins contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRE, ProtAM TRE and ProtPM TRE in people with Generally Healthy Adults Over 60 Years Old, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yana Petkova (+44 7513 679 635, yp00228@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.