Back to resultsChronic Effect of Fasting
Primary Purpose
Overweight and Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Caloric restriction only
Caloric restriction plus TRF morning
Caloric restriction plus TRF night
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Obesity, Overweight, Weight loss, Fasting
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).
Sites / Locations
- Hospital da ClínicasRecruiting
- Hospital das ClínicasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Caloric restriction only
Caloric restriction plus TRF morning
Caloric restriction plus TRF night
Arm Description
Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy.
Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.
Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.
Outcomes
Primary Outcome Measures
Change in body weight
Body weight will be assessed by mechanical scale
Secondary Outcome Measures
Change in body composition
Body composition will be assessed by electrical bioimpedance
Change in resting energy expenditure
Resting energy expenditure will be assessed by indirect calorimetry
Change in self-reported energy intake
Dietary energy intake will be assessed with 3-days food records
Change in self-reported diet composition
Dietary macronutrient intake will be assessed with 3-days food records
Change in self-reported intervention adherence
Adherence will be assessed by daily record of feeding hours
Change in metabolic profile
Fasting lipids, glucose and free fatty acids
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.
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.
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.
Full Information
NCT ID
NCT03574103
First Posted
June 19, 2018
Last Updated
September 11, 2023
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT03574103
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Obesity, Overweight, Weight loss, Fasting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caloric restriction only
Arm Type
Active Comparator
Arm Description
Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy.
Arm Title
Caloric restriction plus TRF morning
Arm Type
Experimental
Arm Description
Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.
Arm Title
Caloric restriction plus TRF night
Arm Type
Experimental
Arm Description
Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.
Intervention Type
Behavioral
Intervention Name(s)
Caloric restriction only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caloric restriction plus TRF morning
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caloric restriction plus TRF night
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight
Description
Body weight will be assessed by mechanical scale
Time Frame
Baseline and weeks 2, 4 and 8
Secondary Outcome Measure Information:
Title
Change in body composition
Description
Body composition will be assessed by electrical bioimpedance
Time Frame
Baseline and weeks 2, 4 and 8
Title
Change in resting energy expenditure
Description
Resting energy expenditure will be assessed by indirect calorimetry
Time Frame
Baseline and weeks 2, 4 and 8
Title
Change in self-reported energy intake
Description
Dietary energy intake will be assessed with 3-days food records
Time Frame
Baseline and weeks 2, 4 and 8
Title
Change in self-reported diet composition
Description
Dietary macronutrient intake will be assessed with 3-days food records
Time Frame
Baseline and weeks 2, 4 and 8
Title
Change in self-reported intervention adherence
Description
Adherence will be assessed by daily record of feeding hours
Time Frame
Baseline and weeks 2, 4 and 8
Title
Change in metabolic profile
Description
Fasting lipids, glucose and free fatty acids
Time Frame
Baseline and weeks 2, 4 and 8
Title
Change in self-reported stress
Description
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
Title
Change in self-reported anxiety
Description
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
Title
Change in self-reported depression
Description
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
Other Pre-specified Outcome Measures:
Title
High-sensitivity C-reactive protein
Description
Change will be assessed in blood sample
Time Frame
Baseline and weeks 2, 4 and 8
Title
Insulin
Description
Change will be assessed in blood sample
Time Frame
Baseline and weeks 2, 4 and 8
Title
Leptin
Description
Change will be assessed in blood sample
Time Frame
Baseline and weeks 2, 4 and 8
Title
Ghrelin
Description
Change will be assessed in blood sample
Time Frame
Baseline and weeks 2, 4 and 8
Title
Brain-Derived Neurotrophic Factor (BDNF)
Description
Change will be assessed in blood sample
Time Frame
Baseline and weeks 2, 4 and 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adaliene VM Ferreira, PhD
Phone
+553134093680
Email
adaliene@gmail.com
Facility Information:
Facility Name
Hospital da Clínicas
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adaliene VM Ferreira, PhD
Phone
+553134093680
Email
adaliene@gmail.com
Facility Name
Hospital das Clínicas
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adaliene VM Ferreira, PhD
Phone
+553134093680
Email
adaliene@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33512717
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.
Results Reference
derived
Learn more about this trial
Chronic Effect of Fasting
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