ObesitynutritionNCT03642925
Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control
A study testing Meal replacement diet in people with Obesity and Diet Modification, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in Taiwanese obese subjects. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diet Modification, Nutrient; Excess
- What is being tested?
- Meal replacement diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Nov 2015to 1 Mar 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy obese subject (BMI >27)
- Aged between 20 to 80 of both genders with a desire to lose weight.
Who cannot join
- Subjects with cancer
- Hyperglycemic (diabetic)
- Hypertension,
- Stroke
- Renal dysfunction
- Cardiac or hepatic dysfunctio
- allergic to the dairy product and eating disorders
- Pregnancy, nursing (lactating), chain smokers and heavy alcoholic subjects
Trial locations and contacts
1 site in 1 country.
About this study
The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in Taiwanese obese subjects. Various parameters like anthropometric (body weight, body fat, waist circumference), lipid profile (TC, LDL-c and TG), cardiovascular risk factors, glycemic and oxidative markers as well as renal and hepatic markers were evaluated.
Read the detailed description
The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects. Obese subjects (BMI>27; n=50, male 23, female 27) were recruited and requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.
- Conditions
- Obesity, Diet Modification, Nutrient; Excess
- Being tested
- Meal replacement diet
- Keywords
- Meal replacement, calorie restriction, body weight
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal replacement dietDietary supplement
Obese subjects were requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.
| Study group | Role | What they receive |
|---|---|---|
| Meal replacement diet | Experimental | Obese subjects (BMI>27; n=50, male 23, female 27) were requested to replace (intervention) two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks Receives: Dietary Supplement: Meal replacement diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calorie intake in obese subjects
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal)
Measured: 8 weeks
Anthropometric parameter
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg)
Measured: 8 weeks
Anthropometric parameter
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2)
Measured: 8 Weeks
Cardiovascular (CV) risk factors
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in CV risk factor like Homocysteine (umol/L)
Measured: 8 Weeks
Glycemic markers
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in Glycemic marker like FBG (mg/dL)
Measured: 8 Weeks
Lipid profile
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start21 Nov 2015
- Primary completion21 Jan 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Kun Wang, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642925
- Sponsor's protocol ID
- CS15124
- Acronym
- nutrition
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control
- ClinicalTrials.gov ID
- NCT03642925
- Acronym / sponsor ID
- nutrition / CS15124
- Conditions
- Obesity, Diet Modification, Nutrient; Excess
- Keywords
- Meal replacement, calorie restriction, body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 21 Nov 2015 (actual)
- Primary completion
- 21 Jan 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 22 Aug 2018 (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 present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in Taiwanese obese subjects. Various parameters like anthropometric (body weight, body fat, waist circumference), lipid profile (TC, LDL-c and TG), cardiovascular risk factors, glycemic and oxidative markers as well as renal and hepatic markers were evaluated.
Detailed description
The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects. Obese subjects (BMI>27; n=50, male 23, female 27) were recruited and requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects.
| Arm | Type | Receives |
|---|---|---|
| Meal replacement diet | Experimental | Dietary Supplement: Meal replacement dietObese subjects (BMI>27; n=50, male 23, female 27) were requested to replace (intervention) two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy obese subject (BMI >27)
- Aged between 20 to 80 of both genders with a desire to lose weight.
Key exclusion criteria (8 listed)
- Subjects with cancer
- Hyperglycemic (diabetic)
- Hypertension,
- Stroke
- Renal dysfunction
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 |
|---|---|---|
| Meal replacement dietObese subjects were requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women. | Dietary supplement | Meal replacement diet |
Primary outcome
Calorie intake in obese subjects
Time frame: 8 weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in calories (Kcal)
Anthropometric parameter
Time frame: 8 weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in body weight (kg)
Anthropometric parameter
Time frame: 8 Weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the change in BMI (Kg/m2)
Cardiovascular (CV) risk factors
Time frame: 8 Weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in CV risk factor like Homocysteine (umol/L)
Glycemic markers
Time frame: 8 Weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in Glycemic marker like FBG (mg/dL)
Lipid profile
Time frame: 8 weeks
Intervention with calorie restricted meal replacement diet for 8 weeks to check the changes in total cholesterol (mg/dl)
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 22 Aug 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal replacement diet in people with Obesity and Diet Modification, run by Chung Shan Medical University at 1 site in Taiwan.
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 8 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 22 Aug 2018. 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 Taiwan. 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?
Calorie intake in obese subjects (time frame: 8 weeks). The study lists 6 primary outcomes in all. 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 22 Aug 2018.