Chronic Effect of Fasting
- Conditions
- Overweight and Obesity
- Interventions
- Behavioral: Caloric restriction onlyBehavioral: Caloric restriction plus TRF morningBehavioral: Caloric restriction plus TRF night
- Registration Number
- NCT03574103
- Lead Sponsor
- Federal University of Minas Gerais
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 45
- Females;
- Aged between 18 and 59 years old;
- Body mass index equal or greater 25 kg/m²;
- Agree to sign the informed consent.
- Any chronic health conditions (e.g. chronic renal failure, autoimmune, heart, and liver disease);
- Thyroid diseases or medications for its treatment;
- Medications known to affect total energy expenditure;
- Use of steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight-loss medications, oral hypoglycemic agents or insulin and any medications that influence metabolic and/or inflammatory parameters;
- Previous surgery for weight loss;
- Pregnancy or breast-feeding;
- Smoking;
- Alcohol use (>2 doses/day).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Caloric restriction only Caloric restriction only Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy. Caloric restriction plus TRF morning Caloric restriction plus TRF morning Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy. Caloric restriction plus TRF night Caloric restriction plus TRF night Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.
- Primary Outcome Measures
Name Time Method Change in body weight Baseline and weeks 2, 4 and 8 Body weight will be assessed by mechanical scale
- Secondary Outcome Measures
Name Time Method Change in resting energy expenditure Baseline and weeks 2, 4 and 8 Resting energy expenditure will be assessed by indirect calorimetry
Change in self-reported diet composition Baseline and weeks 2, 4 and 8 Dietary macronutrient intake will be assessed with 3-days food records
Change in self-reported intervention adherence Baseline and weeks 2, 4 and 8 Adherence will be assessed by daily record of feeding hours
Change in self-reported depression Baseline and weeks 2, 4 and 8 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.
Change in self-reported anxiety Baseline and weeks 2, 4 and 8 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.
Change in self-reported stress Baseline and weeks 2, 4 and 8 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.
Change in body composition Baseline and weeks 2, 4 and 8 Body composition will be assessed by electrical bioimpedance
Change in self-reported energy intake Baseline and weeks 2, 4 and 8 Dietary energy intake will be assessed with 3-days food records
Change in metabolic profile Baseline and weeks 2, 4 and 8 Fasting lipids, glucose and free fatty acids
Trial Locations
- Locations (2)
Hospital da Clínicas
🇧🇷Belo Horizonte, MG, Brazil
Hospital das Clínicas
🇧🇷Belo Horizonte, Minas Gerais, Brazil