Time-restricted feeding in overweight women
| ISRCTN | ISRCTN11777276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11777276 |
- Submission date
- 22/01/2024
- Registration date
- 24/01/2024
- Last edited
- 23/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
This study aimed to determine the effects of ad libitum time-restricted feeding (TRF) applied for six weeks on body weight, body composition, and metabolic health parameters in overweight women in Balıkesir, Turkiye. This study aims to show that an 8 h food deprivation approach in participants from a developing country with limited education and social vulnerability is effective, feasible, and adaptable for treating obesity.
Who can participate?
Women aged between 19 and 65 who are overweight (BMI: 25-29.99 kg/m2)
What does the study involve?
This clinical trial will be conducted with a six-week follow-up period. In the TRF diet, women are instructed to eat ad libitum only for 8 hours (10:00-18:00). A survey form containing socio-demographic information, general health information, nutritional habits, and 24 h retrospective dietary recall will be administered to the individuals by the researchers via face-to-face interview technique. Anthropometric measurements, body compositions, biochemical parameters, and vital signs are evaluated before and after TRF.
What are the possible benefits and risks of participating?
It does not require buying different foods and offers participants flexibility in starting their fasting period during the intervention.
Where is the study run from?
Balıkesir Atatürk City Hospital (Turkey)
When is the study starting and how long is it expected to run for?
November 2020 to February 2022
Who is funding the study?
This research received no specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Who is the main contact?
Saniye Bilici, sgbilici@gazi.edu.tr (Turkey)
Contact information
Prof Saniye Bilici
Public, Scientific, Principal Investigator
Public, Scientific, Principal Investigator
Gazi Üniversitesi, Sağlık Bilimleri Fakültesi, Beslenme ve Diyetetik Bölümü, Emek, Bişkek Cd. 6. sk D:No: 2
Ankara
06490
Türkiye
 ORCID ID |
0000-0002-1235-0329 |
|---|---|
| Phone | +903122162641 |
| sgbilici@gazi.edu.tr |
Study information
| Study design | Longitudinal case crossover study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case crossover study |
| Study setting(s) | Home, Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A clinical trial reveals the effects of time-restricted feeding in overweight women |
| Study hypothesis | This study hypothesized that optional time-restricted feeding (TRF) administered for six weeks in overweight women has an effect on body weight, body composition, and metabolic health parameters. |
| Ethics approval(s) |
Approved 26/01/2021, Ethics Committee of the Gazi University (Emniyet Mah. Bandırma Cad. No: 6/1, Ankara, 06560, Türkiye; +90 312 202 20 57; gaziuniversitesi@hs01.kep.tr), ref: 2021-134 |
| Condition | Overweight women |
| Intervention | 8-hour time-restricted ad libitum eating for six weeks intervention While the beneficial impacts of time-restricted eating (TRE) on health extend beyond weight loss; it's crucial to recognize the potential influence of aligning eating patterns with the circadian rhythm. Nevertheless, the current body of TRE research remains limited, with clinical trials often a control group subjected to an identical energy intake as the experimental group. This limitation hinders our ability to definitively attribute observed effects to changes in food selection or the fasting regimen to overlook the potential influence of the circadian rhythm. Since different individual parameters will come into play in shaping food preferences, in TRE studies where ad libitum diet is offered, intervening in the same individuals and evaluating before and after TRE will be beneficial in eliminating individual differences in food selection and other variations. For these reasons, this study was planned to determine the effects of ad libitum TRE applied for six weeks on body weight, body composition, and metabolic health parameters in overweight women. At the beginning of the study, the researchers administered a survey form containing socio-demographic information, general health information, nutritional habits, and 24-hour retrospective dietary recall via face-to-face interview. Six weeks after the beginning of the study, 24-hour dietary records for three consecutive days were taken from the individuals. The dietary records’ energy, macronutrient, and micronutrient contents were analyzed using the BeBiS (Nutrition Information System) program (version 8.2). Body weight (kg), body fat mass (kg), body fat percentages (%), lean body mass (kg), and total body water (%) measurements were obtained by Tanita BC 545 N bioelectric impedance device-BIA. Height measurements of the participants were collected. The waist circumference measurement protocol used in the study was based on bony landmarks (the midpoint of the iliac crest and the last rib). The neck circumference was measured at mid-neck, between the mid-cervical spine and the mid-anterior neck, on women standing upright and facing forwards, with shoulders relaxed. After 12 h fasting, a 10-mL venous blood specimen was collected from the women, using a venous container, at baseline and after the sixth week of the research. Blood glucose, insulin, HOMA-IR, total cholesterol, LDL-C, HDL-C, triglyceride, AST, and ALT values of the women were measured and calculated by biochemistry technicians in the biochemistry laboratory of Balıkesir Atatürk City Hospital. The researchers measured the participants’ blood pressure using an Omron M2 Basic HEM-7121J-E upper arm digital blood pressure monitor. In the study, a single TRE intervention was performed, and the parameters to be evaluated in individuals were compared before and after the TRE. In the TRE diet, women were instructed to eat ad libitum only during an 8 h period (10:00-18:00) and fasted during the other 16 hours, from the last meal for a total duration of six weeks. The participants were not given any particular nutritional instructions, making the trial conditions resemble real-life scenarios. While fasting, the participants were encouraged to drink large amounts of water, tea with no sugar added, black coffee, or no-calorie sparkling water. At the beginning of the study, the researchers administered a survey form containing socio-demographic information, general health information, nutritional habits, and 24-hour retrospective dietary recall via face-to-face interview. Six weeks after the beginning of the study, 24-hour dietary records for three consecutive days were taken from the individuals. In the study, during the 6-week follow-up period, routine control interviews were held with individuals via social media, online, and by phone, and their compliance with feeding hours was closely monitored. Participants kept 24-hour dietary records of their food consumption, noting meal items and quantities, or they captured photos of their meals and instantly shared them with the dietitian to maintain a more accurate food log. The dietitians maintained ongoing communication with the participants, offering information and words of encouragement. The dietary records’ energy, macronutrient, and micronutrient contents were analyzed using the BeBiS (Nutrition Information System) program (version 8.2). At the beginning of the study, the researchers administered a survey form containing socio-demographic information, general health information, nutritional habits, and 24-hour retrospective dietary recall via face-to-face interview. Six weeks after the beginning of the study, 24-hour dietary records for three consecutive days were taken from the individuals. The dietary records’ energy, macronutrient, and micronutrient contents were analyzed using the BeBiS (Nutrition Information System) program (version 8.2). Body weight (kg), body fat mass (kg), body fat percentages (%), lean body mass (kg), and total body water (%) measurements were obtained by Tanita BC 545 N bioelectric impedance device-BIA. Height measurements of the participants were collected. The waist circumference measurement protocol used in the study was based on bony landmarks (the midpoint of the iliac crest and the last rib). The neck circumference was measured at mid-neck, between the mid-cervical spine and the mid-anterior neck, on women standing upright and facing forwards, with shoulders relaxed. After 12 h fasting, a 10-mL venous blood specimen was collected from the women, using a venous container, at baseline and after the sixth week of the research. Blood glucose, insulin, HOMA-IR, total cholesterol, LDL-C, HDL-C, triglyceride, AST, and ALT values of the women were measured and calculated by biochemistry technicians in the biochemistry laboratory of Balıkesir Atatürk City Hospital. The researchers measured the participants’ blood pressure using an Omron M2 Basic HEM-7121J-E upper arm digital blood pressure monitor. The intervention was provided by 2 nutritionists and 1 dietician. The data was provided individually by a face-to-face mechanism at Balıkesir Atatürk City Hospital Diet Polyclinic, Bursa, Türkiye and Gazi University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Ankara, Türkiye. In the study, a single TRE intervention was performed, and the parameters to be evaluated in individuals were compared before and after the TRE. In the TRE diet, women were instructed to eat ad libitum only during an 8 h period (10:00-18:00) and fasted during the other 16 hours, from the last meal for a total duration of six weeks. The participants were not given any particular nutritional instructions, making the trial conditions resemble real-life scenarios. While fasting, the participants were encouraged to drink large amounts of water, tea with no sugar added, black coffee, or no-calorie sparkling water. Intervention adherence or fidelity was not assessed. In the study, during the 6-week follow-up period, routine control interviews were held with individuals via social media, online, and by phone, and their compliance with feeding hours was closely monitored. Intervention adherence or fidelity was not assessed. |
| Intervention type | Behavioural |
| Primary outcome measure | The following primary outcome variables were assessed before the intervention and after the six-week follow-up period: 1. Body weight was measured using Tanita BC 545 N bioelectric impedance device-BIA 2. Body fat mass was measured using Tanita BC 545 N bioelectric impedance device-BIA 3. Waist circumference was measured using a non-stretching measuring tape ruler 4. Neck circumference was non-stretching measuring tape ruler 5. Blood glucose concentration was measured and calculated by biochemistry technicians in the biochemistry laboratory of Balıkesir Atatürk City Hospital 6. Levels of insulin, HOMA-IR, LDL-C, HDL-C, triglyceride, and ALT were measured and calculated by biochemistry technicians in the biochemistry laboratory of Balıkesir Atatürk City Hospital. |
| Secondary outcome measures | 1. Dietary energy content was measured from the 24-hour dietary records of their food consumption using the BeBiS (Nutrition Information System) program (version 8.2). 2. Macronutrient levels were measured from the 24-hour dietary records of their food consumption using the BeBiS (Nutrition Information System) program (version 8.2). |
| Overall study start date | 01/11/2020 |
| Overall study end date | 15/02/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 43 |
| Total final enrolment | 43 |
| Participant inclusion criteria | 1. Female 2. Aged between 19 and 65 years old 3. BMI: 25-29.99 kg/m2 4. Stable body weight for at least one month 5. Non-smoking 6. Consumption of < 140 g/wk of alcohol 7. Light exercise (<60 min/week of moderate exercise) 8. Consent, is indicated by signing the human-subject research agreement form |
| Participant exclusion criteria | 1. Women on chronic medication use 2. Those with a pacemaker or platinum in their body 3. Individuals in the postmenopausal state 4. Pregnant or breastfeeding women 5. Individuals working shift work 6. Those with a history of cancer 7. Individuals with obsessive-compulsive disorder |
| Recruitment start date | 01/02/2021 |
| Recruitment end date | 01/02/2022 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Balıkesir Atatürk City Hospital
Balıkesir Atatürk City Hospital Diet Polyclinic
Balıkesir
10020
Türkiye
Balıkesir
10020
Türkiye
Sponsor information
Gazi University
University/education
University/education
Emek mah. Bişkek Cad. 6. Cad. (eski 81. sokak) No:2
Gazi Univertsiy, Faculty of Health Sciences, Department of Nutrition and Dietetics
Ankara
06490
Türkiye
| Phone | +90 312 216 2641 |
|---|---|
| sgbilici@gmail.com | |
| Website | https://gazi.edu.tr/ |
"ROR" |
https://ror.org/054xkpr46 |
Funders
Funder type
Other
Investigator intiated and funded
No information available
Results and Publications
| Intention to publish date | 01/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Saniye Bilici, sgbilici@gazi.edu.tr. The type of data that will be shared is raw data as an SPPS file. Requests can be made for 1 year. Consent from participants was obtained. Data will be anonymized. There are no ethical or legal restrictions. |
Editorial Notes
23/01/2024: Study's existence confirmed by the Gazi University Ethics Commission.
