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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-Restricted Feeding | Other | Participants followed a four-week regimen of ad libitum food intake from 08:00 to 18:00, followed by a 14-hour fasting period until 08:00 the next day, while maintaining habitual physical activity and sleep patterns. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-Restricted Feeding | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harokopio University of Athens | Athens | Attica | 17676 | Greece |
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| 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 | Baseline and week 4 |
| Changes from Baseline in Glycemic and Lipidemic Profile, assessed by photometry. | Biochemical measurements in blood. | Baseline and Week 4 |