Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Effect of Fasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574103
Recruitment Status : Suspended (The study has been temporarily suspended due to the SARS-CoV-2 pandemic.)
First Posted : June 29, 2018
Last Update Posted : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
Adaliene Versiani M. Ferreira, Federal University of Minas Gerais

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Caloric restriction only Behavioral: Caloric restriction plus TRF morning Behavioral: Caloric restriction plus TRF night Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Weight Loss Induced by Daily Time-Restricted Feeding Versus Daily Caloric Restriction in Women With Overweight and Obesity
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Caloric restriction only
Participants in this group will receive a eating plan with caloric restriction as dietary weight loss strategy.
 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.
Experimental: Caloric restriction plus TRF morning
Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.
 Behavioral: 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.
Experimental: Caloric restriction plus TRF night
Participants in this group will receive a eating plan with caloric and time restriction as dietary weight loss strategy.
 Behavioral: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Body weight will be assessed by mechanical scale


Secondary Outcome Measures :
  1. Change in body composition [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Body composition will be assessed by electrical bioimpedance

  2. Change in resting energy expenditure [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Resting energy expenditure will be assessed by indirect calorimetry

  3. Change in self-reported energy intake [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Dietary energy intake will be assessed with 3-days food records

  4. Change in self-reported diet composition [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Dietary macronutrient intake will be assessed with 3-days food records

  5. Change in self-reported intervention adherence [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Adherence will be assessed by daily record of feeding hours

  6. Change in metabolic profile [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Fasting lipids, glucose and free fatty acids

  7. Change in self-reported stress [ 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.

  8. Change in self-reported anxiety [ 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.

  9. Change in self-reported depression [ 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.


Other Outcome Measures:
  1. High-sensitivity C-reactive protein [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Change will be assessed in blood sample

  2. Insulin [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Change will be assessed in blood sample

  3. Leptin [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Change will be assessed in blood sample

  4. Ghrelin [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Change will be assessed in blood sample

  5. Brain-Derived Neurotrophic Factor (BDNF) [ Time Frame: Baseline and weeks 2, 4 and 8 ]
    Change will be assessed in blood sample


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574103


Locations
Layout table for location information
Brazil
Hospital da Clínicas
Belo Horizonte, MG, Brazil, 30130-100
Hospital das Clínicas
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Sponsors and Collaborators
Federal University of Minas Gerais
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Adaliene Versiani M. Ferreira, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03574103    
Other Study ID Numbers: Chronic 72774617.6.0000.5149
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adaliene Versiani M. Ferreira, Federal University of Minas Gerais:
Obesity
Overweight
Weight loss
Fasting
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight