Time-restricted Eating (TRE) and Protein in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Surrey
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TRE
Other intervention* 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
Other intervention* 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
Other intervention* 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.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: TREExperimental treatment 1 intervention
Group B: ProtAM TREExperimental treatment 1 intervention
Group C: ProtPM TREExperimental treatment 1 intervention
Group D: ControlNo intervention 0 interventions
Trial outcomes
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 intervention2
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 intervention3
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 interventionSecondary outcomes
1
Change in fasting glucose control indicators
HbA1c
Time frame
At the start and end of 8 weeks of the assigned study intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
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Source ClinicalTrials.gov