Chronic Effect of Fasting

Federal University of Minas Gerais

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Behavioral: Caloric restriction plus TRF night; Behavioral: Caloric restriction plus TRF morning; Behavioral: Caloric restriction only

Study type: Interventional

Funder types: Other

Identifiers

NCT03574103

Chronic 72774617.6.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Caloric restriction only

Active Comparator group

Description:

Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy.

Treatment:

Behavioral: Caloric restriction only

Caloric restriction plus TRF morning

Experimental group

Description:

Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.

Treatment:

Behavioral: Caloric restriction plus TRF morning

Caloric restriction plus TRF night

Experimental group

Description:

Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.

Treatment:

Behavioral: Caloric restriction plus TRF night