The effects of fruit before meals on regulating fullness and changing body measurements
| ISRCTN | ISRCTN16542275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16542275 |
| Secondary identifying numbers | 01/02/05/65/ID.33720112P211142020020600002 |
- Submission date
- 20/02/2024
- Registration date
- 28/02/2024
- Last edited
- 26/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Overweight and obesity are impending major public health concerns. It is estimated that around 2.6 billion people were overweight or obese (body mass index [BMI] 25 kg/m² and over) in 2020, representing 38% of the world population. Currently, no definitive treatments are available and clinically recommended, even though overweight and obesity are the risk factors for multiple diseases. Here, the researchers aimed to conduct a study of the effects of fruit before meals and walking after meals in overweight and obese individuals.
Who can participate?
Healthy adults aged 20-29 years old with a BMI over 23 kg/m².
What does the study involve?
Participants are randomly allocated into four groups. The first group is a placebo group that does not receive any treatment. The second group consumed fruit before meals (breakfast, lunch and dinner) whilst the third group performed a 10-minute walk after meals. The fourth group is the combination of fruit before a meal and a 10-minute walk after a meal. Before the intervention, laboratory assistants took blood samples to measure fasting blood glucose levels and DPP4 enzyme activity.
What are the possible benefits and risks of participating?
All participants received free diet education and BMI, waist circumference, fasting blood glucose, and DPP4 enzyme activity measurements. The possible risks were allergy to fresh fruits and stomach and foot muscle cramps during walking after meals.
Where is the study run from?
Universitas Sebelas Maret (Indonesia)
When is the study starting, and how long is it expected to run for?
April 2020 to November 2021
Who is funding the study?
Ministry of Education, Culture, Research, and Technology (Indonesia)
Who is the main contact?
Dono Indarto, MD PhD, dono@staff.uns.ac.id
Contact information
Public, Scientific, Principal Investigator
Biomedical Laboratory
Faculty of Medicine
Universitas Sebelas Maret
Jl. Ir. Sutami 36A Kentingan
Jebres
Surakarta
57126
Indonesia
 ORCID ID |
0000-0001-7420-5816 |
|---|---|
| Phone | +62 (0)85601579139 |
| dono@staff.uns.ac.id |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Charity/Voluntary sector, Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Fruit before meals preserves satiety and affects anthropometric measurements in overweight and obese individuals: a randomized controlled trial of fruits before meals and physical exercise after meals |
| Study acronym | FBM |
| Study objectives | Fruit meal sequence with or without combination of postprandial exercise (PE) preserve satiety and reduce anthropometric measurements in the overweight and obese individuals. |
| Ethics approval(s) |
Approved 08/04/2020, Research Ethical Committee, Faculty of Medicine, Universitas Sebelas Maret (Jl. Ir. Sutami 36A Kentingan, Jebres, Surakarta, 57126, Indonesia; +62 (0)271664178; kepk@fk.uns.ac.id), ref: 042/UN27.06.6.1/KEPK/EC/2020 |
| Health condition(s) or problem(s) studied | Obese and overweight |
| Intervention | Participants were randomly allocated into four groups using folded paper. The first group is a placebo group that does not receive any treatment. The second group consumed fruit before meals (breakfast, lunch and dinner) whilst the third group performed a 10-minute walk after meals. The fourth group is the combination of fruit before a meal and a 10-minute walk after a meal. A total of 500 g of mixed fruits per day were consumed by participants in groups two and four which consisted of orange, banana, fuji apple (Cripps Pink), green apple (Granny Smith), snakefruit, papaya, pear, apple guava, water guava, and dragon fruit. The duration of the intervention was 30 days. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Nutritional intake: The daily food intake of all selected participants was assessed using the 24-hour food recall questionnaire on days 0, 15, and 30 and converted into daily intake values of nutrients using the free NutriSurvey software (https://www.nutrisurvey.de), translated into Indonesian. 2. Anthropometric measurements: body weight (kg) was measured after the participants emptied the bladder and was done without shoes. Height (cm) was measured using a stadiometer to calculate the distance between the top of the head (vertex) and the bottom of the foot. Body mass index (BMI) was calculated by dividing the weight in kilograms by the square of the height in meters with the cut-off points from the World Health Organization (WHO) classification for the Asian population. The anthropometric measurements were assessed on days 0, 15, and 30. 3. Waist circumference: Participants stood up straight and breathed normally. The waist circumference of all selected participants was measured midway between the top of the hip bone and the bottom rib bone using a metline on days 0, 15, and 30. 4. Fasting blood glucose levels: All selected participants were fasting for 8 hours before taking venous blood samples in the morning on days 0, 15, and 30. Labelled blood samples were collected into coagulant tubes and then sent to the clinical laboratory to measure fasting blood glucose levels using a routine hexokinase method. 5. Food satiety (fullness) indexes: food satiety indexes were measured using Satiety Labelled Intensity Magnitude (SLIM). The SLIM was a 100-mm bidirectional hunger-fullness scale for assessing food satiety in individuals after a meal. The measurement was performed 30, 60, 90, 120, and 150 minutes after meals on days 0 and 30. |
| Secondary outcome measures | Dipeptidyl peptidase (DPP4) activity assay: Serum blood samples were diluted with phosphate-buffered (PBS) pH 7.4. A DPP4 substrate, H-Gly-Prop-nitroanilide (Sigma-Aldrich, St. Louis, MO, USA) was dissolved with the PBS to achieve a 2 mM final concentration. Blood samples were mixed and homogenized with the substrate working solution in a 1:1 ratio. The DPP4 activity was read using a spectrophotometer at λ = 405 nm at 25°C every 10 min for 60 min. The Beer-Lambert formula was used to calculate the DPP4 activity. |
| Overall study start date | 08/04/2020 |
| Completion date | 24/11/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 29 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. Aged 20-29 years 2. Body mass index (BMI) >23 kg/cm2 |
| Key exclusion criteria | Individuals with chronic diseases such as heart, renal, and hepatic diseases |
| Date of first enrolment | 01/12/2020 |
| Date of final enrolment | 10/02/2021 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Jl. Ir. Sutami 36A Kentingan, Jebres
Surakarta
57126
Indonesia
Sponsor information
University/education
Jl. Ir. Sutami 36A Kentingan, Jebres
Surakarta
57126
Indonesia
| Phone | +62 (0)271632916 |
|---|---|
| lppm@uns.ac.id | |
| Website | https://www.lppm.uns.ac.id |
"ROR" |
https://ror.org/021hq5q33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Education, Culture, Research, and Technology, Ministry of Education, Culture, Research, and Technology, Republic of Indonesia, Kemdikbudristek, Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi, Republik Indonesia, Indonesia Ministry of Education, Culture, Research, and Technology, Indonesian Ministry of Education, Culture, Research, and Technology, Kementerian Pendidikan, Kebudayaan, Riset, dan Teknologi, MECRT, Kemdikbudristek
- Location
- Indonesia
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers plan to publish in an international peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dono Indarto, MD PhD, dono@staff.uns.ac.id. |
Editorial Notes
20/02/2024: Study's existence confirmed by the Research Ethical Committee, Faculty of Medicine, Universitas Sebelas Maret.
