Time-restricted Feeding and Health

Harokopio University16 enrolled

Overview

The purpose of this pilot, single-arm clinical trial is to assess the effects of time-restricted feeding on overall health, including body composition, glycemic and lipidemic profile, as well as appetite-regulating hormones, including glucagon-like peptides 1(GLP-1) oxyntomodulin, glucagon. Additionally, the study aims to evaluate the impact of this dietary pattern on circadian rhythm parameters, including acrophase, mesor, and amplitude.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Appetite Circadian Rhythm Metabolic Health Body Weight Control Glycemic and Insulinemic Response

Interventions

Time-Restricted FeedingOTHER

Ad libitum food intake from 08:00 to 18:00, followed by fasting from 18:00 to 08:00 for four weeks. Outside the eating window, water and limited amounts (1-2 servings) of very low-calorie items (e.g., tea, diet soft drinks, coffee, chewing gum \<4 kcal/serving) were permitted. The intervention focused exclusively on the timing of food intake and did not impose restrictions on the quantity or type of foods consumed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men or women aged 18-35 years * Habitual daily eating window \>10 hours * Stable body weight over the past 3 months (\< ±10% change) * Able to provide informed consent independently Exclusion Criteria: * Night shift work more than once per week * Presence of chronic diseases (e.g., cancer, renal or hepatic disease, inflammatory bowel disease, hypertension, diabetes, cognitive or psychiatric disorders) * Eating disorders * Use of medications affecting the intervention (e.g., corticosteroids, antidiabetics) * Pregnancy or planning pregnancy within the next 12 months * Diagnosis of insomnia

Locations (1)

Harokopio University of Athens

Athens, Attica, Greece

Outcomes

Primary Outcomes

Changes from baseline in appetite-regulating hormones , including GLP-1 in pg/mL, oxyntomodulin in pg/mL, and glucagon in pg/mL at week 4, measured by ELISA kits.

Participants arrived at the laboratory between 08:30 and 09:00. An antecubital catheter was placed, and five blood samples were collected at fasting (0 min) and at 30, 60, 90, and 120 minutes after consuming the test meal. The test meal consisted of 100 g of S-Core FLEX Compact Protein powder (40 g carbohydrate, 29 g protein, 19 g fat) dissolved in 250 mL of water, providing 475 kcal.

Time frame: Baseline and Week 4

Secondary Outcomes

Changes from baseline in circadian rhythm parameters (acrophase in degrees of Celcious, mesor in time units, amplitude in degrees of Celcious) at week 4, measured through continouous measurements in skin termperature by a thermistor.

Participants wore a wireless skin temperature sensor (Thermochron iButton® DS1921-F5) on the palmar surface of the wrist of the non-dominant hand for 2 consecutive days. Circadian rhythmicity was analyzed using Cosinor analysis, which applies the least-squares method to fit the chronobiological data to cosine functions with predetermined periods of 12 and 24 hours.

Time frame: Baseline and Week 4

Changes from baseline in Body Composition, namely fat free mass in kg and fat mass in kg

Participant's body composition measurement pre/post time restricted feeding protocol

Time frame: Baseline and week 4

Changes from Baseline in Glycemic and Lipidemic Profile, assessed by photometry.

Biochemical measurements in blood.

Time frame: Baseline and Week 4

Data from ClinicalTrials.gov

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