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The aim of the study is to determine if time-restricted feeding (TRF) is an effective dietary strategy to weight loss after 8 weeks intervention. TRF will be compared with an intervention without restriction in time for feeding. Both strategies will be with caloric restriction.
The participants of the study will be divided in two groups: (1) a group with caloric restriction and without restriction in time for feeding and (2) a group with caloric restriction and restriction in time for feeding. This second group will be subdivided according to the participant's preference: (2.1) first meal at 8 a.m. and last meal at 4 p.m. or (2.2) first meal at 12 p.m. and last meal at 8 p.m. The caloric restriction for all participants will be 513 to 770 kcal from estimated energy requirement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caloric restriction only | Active Comparator | Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy. |
|
| Caloric restriction plus TRF morning | Experimental | Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy. |
|
| Caloric restriction plus TRF night | Experimental | Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric restriction only | Behavioral | Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements), without restriction in time for feeding, for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Body weight will be assessed by mechanical scale | Baseline and weeks 2, 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition | Body composition will be assessed by electrical bioimpedance | Baseline and weeks 2, 4 and 8 |
| Change in resting energy expenditure | Resting energy expenditure will be assessed by indirect calorimetry |
| Measure | Description | Time Frame |
|---|---|---|
| High-sensitivity C-reactive protein | Change will be assessed in blood sample | Baseline and weeks 2, 4 and 8 |
| Insulin | Change will be assessed in blood sample |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adaliene VM Ferreira, PhD | Contact | +553134093680 | adaliene@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da Clínicas | Recruiting | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512717 | Derived | Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Caloric restriction plus TRF morning | Behavioral | Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 12 p.m. to 8 p.m.) and 16 hours of fasting, for 8 weeks. |
|
| Caloric restriction plus TRF night | Behavioral | Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 8 a.m. to 4 p.m.) and 16 hours of fasting, for 8 weeks. |
|
| Baseline and weeks 2, 4 and 8 |
| Change in self-reported energy intake | Dietary energy intake will be assessed with 3-days food records | Baseline and weeks 2, 4 and 8 |
| Change in self-reported diet composition | Dietary macronutrient intake will be assessed with 3-days food records | Baseline and weeks 2, 4 and 8 |
| Change in self-reported intervention adherence | Adherence will be assessed by daily record of feeding hours | Baseline and weeks 2, 4 and 8 |
| Change in metabolic profile | Fasting lipids, glucose and free fatty acids | Baseline and weeks 2, 4 and 8 |
| Change in self-reported stress | Self-reported stress will be assessed by a questionnaire (Perceived Stress Scale). The total of the scale is a sum of scores of 14 questions. Total score can range from zero to 56. The higher the score, the higher the level of stress. | Baseline and weeks 2, 4 and 8 |
| Change in self-reported anxiety | Self-reported anxiety will be assessed by a questionnaire (Beck Anxiety Inventory). The questionnaire consists of 21 items and the severity of each of them scored from 0 to 3. The degree of anxiety will be classified according to the final score obtained: 0-7 absent or minimum; 8-15 light; 16-25 moderate; 26-63 severe. | Baseline and weeks 2, 4 and 8 |
| Change in self-reported depression | Self-reported depression will be assessed by a questionnaire (Beck Depression Inventory). The questionnaire consists of 21 items and the severity of each one scored from 0 to 3. The volunteers will be classified according to the score obtained: BDI ≤ 15: without depression; 16 ≤ BDI ≤ 20: dysphoria; BDI> 20: depression. | Baseline and weeks 2, 4 and 8 |
| Baseline and weeks 2, 4 and 8 |
| Leptin | Change will be assessed in blood sample | Baseline and weeks 2, 4 and 8 |
| Ghrelin | Change will be assessed in blood sample | Baseline and weeks 2, 4 and 8 |
| Brain-Derived Neurotrophic Factor (BDNF) | Change will be assessed in blood sample | Baseline and weeks 2, 4 and 8 |
| Hospital das Clínicas | Recruiting | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |