Clinical trial NCT03574103: Chronic Effect of Fasting
Official title: Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: Obesity
Overweight
Weight loss
Fasting
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline and weeks 2, 4 and 8
Secondary outcomes:
measure: Change in body composition
timeFrame: Baseline and weeks 2, 4 and 8
measure: Change in resting energy expenditure
timeFrame: Baseline and weeks 2, 4 and 8
measure: Change in self-reported energy intake
timeFrame: Baseline and weeks 2, 4 and 8
measure: Change in self-reported diet composition
timeFrame: Baseline and weeks 2, 4 and 8
measure: Change in self-reported intervention adherence
timeFrame: Baseline and weeks 2, 4 and 8
measure: Change in metabolic profile
timeFrame: Baseline and weeks 2, 4 and 8
measure: Change in self-reported stress
timeFrame: Baseline and weeks 2, 4 and 8
measure: Change in self-reported anxiety
timeFrame: Baseline and weeks 2, 4 and 8
measure: Change in self-reported depression
timeFrame: Baseline and weeks 2, 4 and 8
Other outcomes:
measure: High-sensitivity C-reactive protein
timeFrame: Baseline and weeks 2, 4 and 8
measure: Insulin
timeFrame: Baseline and weeks 2, 4 and 8
measure: Leptin
timeFrame: Baseline and weeks 2, 4 and 8
measure: Ghrelin
timeFrame: Baseline and weeks 2, 4 and 8
measure: Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: Baseline and weeks 2, 4 and 8
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital da Clínicas
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas
state: Minas Gerais
Study officials:
References:
citation: 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.