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Fasting Time Effects in Time-Restricted Eating (FaTE-TRE)

Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04503005
Acronym
FaTE-TRE
Enrollment
40
Registered
2020-08-06
Start date
2021-03-08
Completion date
2022-08-31
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting, Intermittent, Healthy Diet

Keywords

time restricted eating, intermitted fasting, body composition, metabolism, inflammation

Brief summary

Over the past century, lifestyles and eating habits have rapidly changed, helping to increase the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular and metabolic diseases such as diabetes. Recently, dietary regimens such as calorie restriction and intermittent fasting have been promoted as new strategies for reducing obesity and related co-morbidities. These strategies have proven effective in reducing body fat, improving blood pressure, lipid profile and insulin resistance in overweight individuals. However, due to the rigidity of these food protocols, the adherence of subjects to the diet is often limited or maintained only for short periods. Time-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the subject's daily calorie intake is consumed only in a certain period of time during the day (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin, HDL, TG). The literature offers numerous versions of intermittent fasting, and the role of fasting duration is not yet fully clear. Thus. the aim of the present study is to investigate the effect od different duration of fasting in a TRE protocol on body composition and lipid and inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on long term maintenance of diet habits, body composition, lipid and inflammatory profile.

Interventions

OTHERTime Restricted Eating

Effect of 16, 14 or 12 hours of daily fasting

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI between 18-30 kg/m2 * Stable body weight for at least 3 months

Exclusion criteria

* type 2 Diabetes or pre-diabetes for ADA guidelines * Significant Chronic disease * recent and acute inflammatory status * Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen. * regular exercise training (≥ 2 sessions/week) or ≥ 10,000 steps/day

Design outcomes

Primary

MeasureTime frameDescription
Body composition2 monthschange of body fat percentage measured via DEXA

Secondary

MeasureTime frameDescription
Blood cholesterol (total, HDL, LDL)2 monthsChange in blood lipid profile
Blood cytokines (IL-6; IL-1, TNF-a)2 monthsChange in blood inflammatory markers
Morningness-Eveningness Questionnaire (MEQ) on chronotype6 montheffect od diet in eating behaviours. Minimum value is 16, maximum value is 86 Morningness-Eveningness Questionnaire (MEQ) scale is 0-41, evening type; 42-58 Neither-type; 58-68 Morning-type

Countries

Italy

Contacts

Primary ContactTatiana Moro, Ph.D
tatiana.moro@unipd.it0498275306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026