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

NCT ID: NCT07314658

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Generally Healthy Adults Over 60 Years Old

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRE

Participants undertaking the TRE intervention

Group Type EXPERIMENTAL

TRE

Intervention Type OTHER

* 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 TRE

Participants undertaking the ProtAM TRE intervention

Group Type EXPERIMENTAL

ProtAM TRE

Intervention Type OTHER

* 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 TRE

Participants undertaking the ProtPM TRE intervention

Group Type EXPERIMENTAL

ProtPM TRE

Intervention Type OTHER

* 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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).

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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TRE + morning protein 'snack' TRE + afternoon protein 'snack'

Eligibility Criteria

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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

* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Surrey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Surrey

Guildford, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Yana Petkova

Role: CONTACT

+44 7513 679 635

Dr Collins

Role: CONTACT

Facility Contacts

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Yana Petkova

Role: primary

+44 7513 679 635

Dr Collins

Role: backup

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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361019

Identifier Type: -

Identifier Source: org_study_id

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