Caloric restriction only
BehavioralParticipants 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.
NCT Number: NCT03574103
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.
Interested in participating?
Request Info18 year–59 year
Female
Interventional
Not applicable
Hospital da Clínicas, Belo Horizonte, Minas Gerais, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Baseline and weeks 2, 4 and 8
Body weight will be assessed by mechanical scale
Time frame: Baseline and weeks 2, 4 and 8
Body composition will be assessed by electrical bioimpedance
Time frame: Baseline and weeks 2, 4 and 8
Resting energy expenditure will be assessed by indirect calorimetry
Time frame: Baseline and weeks 2, 4 and 8
Dietary energy intake will be assessed with 3-days food records
Time frame: Baseline and weeks 2, 4 and 8
Dietary macronutrient intake will be assessed with 3-days food records
Time frame: Baseline and weeks 2, 4 and 8
Adherence will be assessed by daily record of feeding hours
Time frame: Baseline and weeks 2, 4 and 8
Fasting lipids, glucose and free fatty acids
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and weeks 2, 4 and 8
Change will be assessed in blood sample
Time frame: Baseline and weeks 2, 4 and 8
Change will be assessed in blood sample
Time frame: Baseline and weeks 2, 4 and 8
Change will be assessed in blood sample
Time frame: Baseline and weeks 2, 4 and 8
Change will be assessed in blood sample
Time frame: Baseline and weeks 2, 4 and 8
Change will be assessed in blood sample
Contact information is provided by the study sponsor or research team.
Federal University of Minas Gerais
Other
Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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