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

NCT04503005 | Unknown DMC

• 1 other identifier: FaTE-TRE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Diet; Fasting, Intermittent

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Body composition

  change of body fat percentage measured via DEXA

  2 months

Secondary Outcomes (3)

• Blood cholesterol (total, HDL, LDL)

  2 months

• Blood cytokines (IL-6; IL-1, TNF-a)

  2 months

• Morningness-Eveningness Questionnaire (MEQ) on chronotype

  6 month

Study Arms (2)

Effect of fasting duration

ACTIVE COMPARATOR

study the effect of different daily fasting duration on body composition and blood lipid and inflammatory markers in healthy adults.

Other: Time Restricted Eating

Effect of time restricted eating protocol on chronotype

OTHER

study the effect of 2 month of time restricted eating on the chronotype profile of healthy adults.

Other: Time Restricted Eating

Interventions

Time Restricted Eating OTHER

Effect of 16, 14 or 12 hours of daily fasting

Effect of fasting duration; Effect of time restricted eating protocol on chronotype

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

RECRUITING

Related Publications (1)

• Sampieri A, Paoli A, Spinello G, Santinello E, Moro T. Impact of daily fasting duration on body composition and cardiometabolic risk factors during a time-restricted eating protocol: a randomized controlled trial. J Transl Med. 2024 Nov 29;22(1):1086. doi: 10.1186/s12967-024-05849-6.

  PMID: 39614235 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Inflammation

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tatiana Moro, Ph.D

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Moro, Ph.D

CONTACT

0498275306; tatiana.moro@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 6, 2020
• Study Start: March 8, 2021
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2022
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)