Overweight or ObesityNCT05104151
Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite
A study testing Nutritional bar and Healthy Habits Intervention in people with Overweight or Obesity, run by CES University at 1 site in Colombia.
Trial summary
The main objective of the trial is to measure the efficacy of a nutritive bar, in the reduction of weight, body fat and the control of appetite, in patients with overweight and obesity. It will be a randomized single-blind design conducted in 40 subjects. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Nutritional bar and Healthy Habits Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 20 Oct 2017to 27 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight or obesity (BMI range between 25.0 and 35 kg per m2 and
- Percentage of fat ≥28 for women and ≥20 for men
Who cannot join
- Pregnant
- People with gastrointestinal, thyroid, renal, hepatic or cardiovascular diseases.
- Diabetics or hypertensive.
- People with eating disorders.
- Use of anti-obesity drugs in the last 4 weeks.
- Use of nutritional or medicinal anti-obesity supplements in the last 4 weeks.
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- Celiac Disease.
- Allergies to peanuts, nines, eggs, milk or products derived from milk.
- Vegans.
- Physical or mental disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite, in Patients With Overweight or Obesity in the City of medellín, 2017
The main objective of the trial is to measure the efficacy of a nutritive bar, in the reduction of weight, body fat and the control of appetite, in patients with overweight and obesity. It will be a randomized single-blind design conducted in 40 subjects.
Read the detailed description
Primary objective and outcome: Difference in body fat percentage and summation of the absolute value of 7 body folds
Secondary objectives and outcomes:
- Characterize demographically and clinically the population participating in the research study.
- Determine the differences in body weight between the study groups.
- Determine the median of minutes of appetite onset in each of the groups. Design: The proposed study is a randomized, single-blind, paralell, single center study. Number of subjects: The number of subjects will be 40. At the start of the study, subjects will be randomly assigned to 2 different groups. All participants will have a evaluation with a nutritionist for an anthropometric assessment that includes the measurement of percentage of fat, sum of body folds, weight, height and Body Mass Index. All participants will receive a nutritional intervention providing a caloric deficit of 500 calories, depending on their daily requirements,and they will be prescribed moderate physical activity from 60 to 90 minutes daily. Participants will then be randomly assigned to gruop A: the nutritional bar group or group B: Control. Participants in group A will be instructed to consume the nutritional bar as an integral part of the previously established caloric regimen so as not to increase the number of prescribed calories and will be instructed to consume the product twice a day during the whole study, approximately 2 to 4 hours after breakfast and 2 to 4 hours after lunch, without additions of other foods or beverages, during consumption, may only be accompanied with water. Participants in group B will be instructed to consume a nutritious snack corresponding to the amount of calories provided by the bar, 2 to 4 hours after breakfast and 2 to 4 hours after lunch. The nutritional intervention will be carried out for 8 weeks for both groups, during the forth week and during the eight week of the intervention, a new nutritional assessment will be carried out with the same protocol of the first evaluation, by a nutritionist to all participants.
- Conditions
- Overweight or Obesity
- Being tested
- Nutritional bar, Healthy Habits Intervention
- Keywords
- protein, weight control, appetite, overweight and obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional barDietary supplement
Protein-based nutritional bar, providing 155 calories per bar
Healthy Habits InterventionBehavioural
The participants included, will receive a nutritional intervention providing a caloric deficit of 500 calories, depending on their daily requirements, these daily requirements calculated according to the formula BMR (Basic Metabolic Rate). Also prescription of moderate physical activity from 60 to 90 minutes daily will be made.
| Study group | Role | What they receive |
|---|---|---|
| Group with nutritional bar | Experimental | Participants will recieve two nutritional bars per day during eight weeks, and will receive a healthy habits intervention wich includes: nutritional intervention providing a caloric deficit of 500 calories, and a prescription of moderate physical activity from 60 to 90 minutes daily. Receives: Dietary Supplement: Nutritional bar; Behavioral: Healthy Habits Intervention |
| Group without nutritional bar | Active comparator | Participants will receive a healthy habits intervention wich includes nutritional intervention providing a caloric deficit of 500 calories, and a prescription of moderate physical activity from 60 to 90 minutes daily during eight weeks. Receives: Behavioral: Healthy Habits Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in body fat percentage
The difference in changes of corporal body fat will be measured by calculating the percentage of body fat and the summation of the absolute value of 7 body folds. The percentage of body fat will be determined by using the Siri equation (% Fat = 4.95 / Dc) - 4.50 x 100), the calculation of the body density by the Jackson and Pollock anthropometric equation Dc = 1.10938 - 0.0008267 (sum of three folds) + 0.0000016 (sum of three folds) 2 - 0.0002574 years), the body folds for this outcome will be performed according to the International Society for the Advancement of Cineanthropometry (ISAK) protocol, with the body adipometer Harpenden (In women: Triceps, supraspinal and anterior thigh) (in men: pectoral, abdomen and thigh).
Measured: These measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant
Secondary outcomes (3)
Difference in body weight
The subjects will be weighed by means of a balance SECA 813
Measured: This measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant
Determine the median of minutes of appetite onset in each of the groups.
The level of appetite after consumption of the food will be evaluated using an analogue visual scale (AVE). The AVE for appetite ranges from "0" (least appetite) to 10 (maximum appetite or hunger) and will be printed on sheets that will be delivered to the participants on the day of their nutritional evaluation and also by email, in case the lose Participants will be asked to either consume the product for group A or the isocaloric food recommended by the nutritionist for group B for two moments in the day (mid-morning or second feeding of the day and during the mid-afternoon or the fourth meal of the day), the subjects will be asked to write in the format the time of food intake, then the subjects must complete the EVA appetite scale every half hour for 2 hours. write by text message to the researchers the time of food consumption, so that they remind participants to fill out the form every 30 minutes.
Measured: These levels will be measured over two days over the course of week one of the study for both groups
Difference in summation of the absolute value of 7 body folds
The body folds for this outcome will be performed according to the International Society for the Advancement of Cineanthropometry (ISAK) protocol, with the body adipometer Harpenden, the 7 body folds will be (triceps, biceps, subscapular, abdominal, supraspinal, anterior thigh and middle leg), and then will be made the summation of the absolute value of these 7 body folds
Measured: This measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start20 Oct 2017
- Primary completion13 Jun 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a randomized, single-blind, single center, parallel study.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uriel Palacios, CES University
- Investigators
- Uriel Palacios, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104151
- Sponsor's protocol ID
- 668
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will not be shared because the privacy of the participants will be guaranteed by not divulging their names in the scientific study process, or publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite, in Patients With Overweight or Obesity in the City of medellín, 2017
- ClinicalTrials.gov ID
- NCT05104151
- Acronym / sponsor ID
- 668
- Conditions
- Overweight or Obesity
- Keywords
- protein, weight control, appetite, overweight and obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 13 Jun 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the trial is to measure the efficacy of a nutritive bar, in the reduction of weight, body fat and the control of appetite, in patients with overweight and obesity. It will be a randomized single-blind design conducted in 40 subjects.
Detailed description
Primary objective and outcome: Difference in body fat percentage and summation of the absolute value of 7 body folds
Secondary objectives and outcomes:
- Characterize demographically and clinically the population participating in the research study.
- Determine the differences in body weight between the study groups.
- Determine the median of minutes of appetite onset in each of the groups. Design: The proposed study is a randomized, single-blind, paralell, single center study. Number of subjects: The number of subjects will be 40. At the start of the study, subjects will be randomly assigned to 2 different groups. All participants will have a evaluation with a nutritionist for an anthropometric assessment that includes the measurement of percentage of fat, sum of body folds, weight, height and Body Mass Index. All participants will receive a nutritional intervention providing a caloric deficit of 500 calories, depending on their daily requirements,and they will be prescribed moderate physical activity from 60 to 90 minutes daily. Participants will then be randomly assigned to gruop A: the nutritional bar group or group B: Control. Participants in group A will be instructed to consume the nutritional bar as an integral part of the previously established caloric regimen so as not to increase the number of prescribed calories and will be instructed to consume the product twice a day during the whole study, approximately 2 to 4 hours after breakfast and 2 to 4 hours after lunch, without additions of other foods or beverages, during consumption, may only be accompanied with water. Participants in group B will be instructed to consume a nutritious snack corresponding to the amount of calories provided by the bar, 2 to 4 hours after breakfast and 2 to 4 hours after lunch. The nutritional intervention will be carried out for 8 weeks for both groups, during the forth week and during the eight week of the intervention, a new nutritional assessment will be carried out with the same protocol of the first evaluation, by a nutritionist to all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study is a randomized, single-blind, single center, parallel study.
| Arm | Type | Receives |
|---|---|---|
| Group with nutritional bar | Experimental | Dietary Supplement: Nutritional bar, Behavioral: Healthy Habits InterventionParticipants will recieve two nutritional bars per day during eight weeks, and will receive a healthy habits intervention wich includes: nutritional intervention providing a caloric deficit of 500 calories, and a prescription of moderate physical activity from 60 to 90 minutes daily. |
| Group without nutritional bar | Active comparator | Behavioral: Healthy Habits InterventionParticipants will receive a healthy habits intervention wich includes nutritional intervention providing a caloric deficit of 500 calories, and a prescription of moderate physical activity from 60 to 90 minutes daily during eight weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Overweight or obesity (BMI range between 25.0 and 35 kg per m2 and
- Percentage of fat ≥28 for women and ≥20 for men
Key exclusion criteria (10 listed)
- Pregnant
- People with gastrointestinal, thyroid, renal, hepatic or cardiovascular diseases.
- Diabetics or hypertensive.
- People with eating disorders.
- Use of anti-obesity drugs in the last 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional barProtein-based nutritional bar, providing 155 calories per bar | Dietary supplement | Group with nutritional bar |
| Healthy Habits InterventionThe participants included, will receive a nutritional intervention providing a caloric deficit of 500 calories, depending on their daily requirements, these daily requirements calculated according to the formula BMR (Basic Metabolic Rate). Also prescription of moderate physical activity from 60 to 90 minutes daily will be made. | Behavioural | Group with nutritional bar, Group without nutritional bar |
Primary outcome
Difference in body fat percentage
Time frame: These measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant
The difference in changes of corporal body fat will be measured by calculating the percentage of body fat and the summation of the absolute value of 7 body folds. The percentage of body fat will be determined by using the Siri equation (% Fat = 4.95 / Dc) - 4.50 x 100), the calculation of the body density by the Jackson and Pollock anthropometric equation Dc = 1.10938 - 0.0008267 (sum of three folds) + 0.0000016 (sum of three folds) 2 - 0.0002574 years), the body folds for this outcome will be performed according to the International Society for the Advancement of Cineanthropometry (ISAK) protocol, with the body adipometer Harpenden (In women: Triceps, supraspinal and anterior thigh) (in men: pectoral, abdomen and thigh).
3 secondary outcomes
Difference in body weight
Time frame: This measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant
Determine the median of minutes of appetite onset in each of the groups.
Time frame: These levels will be measured over two days over the course of week one of the study for both groups
Difference in summation of the absolute value of 7 body folds
Time frame: This measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: Undecided. IPD will not be shared because the privacy of the participants will be guaranteed by not divulging their names in the scientific study process, or publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uriel Palacios, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional bar and Healthy Habits Intervention in people with Overweight or Obesity, run by CES University at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in body fat percentage (time frame: These measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.