Chronic Effect of Fasting

Overweight and Obesity Clinical Trial

Official title:

Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03574103
• Other study ID #: Chronic 72774617.6.0000.5149
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: Federal University of Minas Gerais
• Contact: Adaliene VM Ferreira, PhD
• Phone: +553134093680
• Email: adaliene[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Females;
• Aged between 18 and 59 years old;
• Body mass index equal or greater 25 kg/m²;
• Agree to sign the informed consent.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Caloric restriction only
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.
• Caloric restriction plus TRF morning
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
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.

Locations

Country	Name	City	State
Brazil	Hospital da Clínicas	Belo Horizonte	MG
Brazil	Hospital das Clínicas	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High-sensitivity C-reactive protein	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Other	Insulin	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Other	Leptin	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Other	Ghrelin	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Other	Brain-Derived Neurotrophic Factor (BDNF)	Change will be assessed in blood sample	Baseline and weeks 2, 4 and 8
Primary	Change in body weight	Body weight will be assessed by mechanical scale	Baseline and weeks 2, 4 and 8
Secondary	Change in body composition	Body composition will be assessed by electrical bioimpedance	Baseline and weeks 2, 4 and 8
Secondary	Change in resting energy expenditure	Resting energy expenditure will be assessed by indirect calorimetry	Baseline and weeks 2, 4 and 8
Secondary	Change in self-reported energy intake	Dietary energy intake will be assessed with 3-days food records	Baseline and weeks 2, 4 and 8
Secondary	Change in self-reported diet composition	Dietary macronutrient intake will be assessed with 3-days food records	Baseline and weeks 2, 4 and 8
Secondary	Change in self-reported intervention adherence	Adherence will be assessed by daily record of feeding hours	Baseline and weeks 2, 4 and 8
Secondary	Change in metabolic profile	Fasting lipids, glucose and free fatty acids	Baseline and weeks 2, 4 and 8
Secondary	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
Secondary	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
Secondary	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