PreDiabetesNCT05273840
Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity
A study testing lifestyle intervention in people with PreDiabetes and Obesity, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
This study aims to improve blood glucose and weight in patients with prediabetes and obesity through health education, nutritional supplement interventions, clinical evaluation, and close clinical follow-up.100 patients with prediabetes with obesity were randomly divided into 2 groups: life intervention group… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PreDiabetes, Obesity
- What is being tested?
- lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2021to Nov 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the American Diabetes Society (ADA) 2010 standard: meet one of the following (1) fasting blood glucose at 100 mg/dl to 125 mg/dl; (2) sugar load 2h blood glucose at 140 mg/dl to 199 mg/dl; (3) glycosylated hemoglobin in 5.7% to 6.4%
- Body mass index (BMI) ≥ 25 and ≤ 35kg/m2
- Have lived locally for at least half a year and have a fixed residence
- No other clinical trials were participated in in the 3 months prior to the trial
- Mental health, being able to take care of oneself in life
Who cannot join
- People with confirmed diabetes
- Weight change of more than 10% over the past 3 months
- Pregnant or lactating women, men and women planning to become pregnant within two years, or unwilling and unable to use contraception during the study period (women only)
- People who are allergic to the ingredients of nutritional supplements
- Those who have lost weight by any medication (including appetite suppressants such as fluprophenylpropanine, progesterone, laxatives, etc., and diet pills with various Traditional Chinese medicine ingredients) or surgery in the past 3 months
- Patients who have received medical treatment for the following diseases in the past 3 months: diabetes, cholecystitis, peptic ulcer, inflammatory bowel disease, acute urinary tract infection, hyperthyroidism, etc., or patients with chronic gastrointestinal diseases with symptoms of nausea, vomiting and diarrhea in the past month
- Suffer from severe organic diseases such as cancer, coronary heart disease, myocardial infarction and stroke
- Presence of pituitary-adrenal axis dysfunction; secondary obesity due to other diseases (e.g., Cushing syndrome, hypothyroidism, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nutritional Supplements (Ivital Control) on Clinical Outcomes in Patients With Prediabetes and Obesity：a Randomized Controlled Study
This study aims to improve blood glucose and weight in patients with prediabetes and obesity through health education, nutritional supplement interventions, clinical evaluation, and close clinical follow-up.100 patients with prediabetes with obesity were randomly divided into 2 groups: life intervention group, nutritional supplement intervention group. All enrolled participants were recommended for routine diabetes lifestyle education according to the "Expert Consensus on Prediabetes Intervention in Adults in China". The duration of the intervention was 3 months. The investigators aimed to compare the differences in weight, glycosylated hemoglobin, lipids and other indicators of the two groups of included populations before and after the intervention. In addition, the investigators are to explore the effects of nutritional supplement interventions on glycolipid metabolism and body weight in prediabetes with obesity.
- Conditions
- PreDiabetes, Obesity
- Being tested
- Ivital Control, lifestyle intervention
- Keywords
- PreDiabetes, Obesity, Glycosylated hemoglobin, weight
- Medical subject headings
- Prediabetic State, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivital ControlDietary supplement
Also called Produced by Fresenius Kabi, Chocolate flavor, Product specifications: 460g (46g*10)
Patients in the intervention group will take 2 sachets of nutritional supplements(Ivital Control) once a day in lieu of one meal, besides receiving lifestyle interventions.
lifestyle interventionBehavioural
Patients will receive lifestyle interventions.
| Study group | Role | What they receive |
|---|---|---|
| life intervention group | Placebo comparator | On the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given to the patients until the end of the visit. Receives: Behavioral: lifestyle intervention |
| nutritional supplement intervention group | Experimental | On the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given, and at the same time, nutritional supplements(Ivital Control) are given to instead a meal per day. 2 bags once a day until the end of the visit. Receives: Dietary Supplement: Ivital Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportions of participants regressing back to normal glucose level
The normal glucose level was defined as FPG < 6.1 mmol/L and 2hPG < 7.8 mmol/L during the OGTT.
Measured: 3 months
Secondary outcomes (2)
change in HbA1c
change in HbA1c
Measured: 3 months
body weight
changes in body weight
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start11 Jun 2021
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. life intervention group 2. nutritional supplement intervention group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273840
- Sponsor's protocol ID
- 2021-R037
- Status last verified
- Jun 2022
- First submitted
- 10 Feb 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Jin L, Zhang P, Li Y, Jin Y, Xu M, Song Q, Li L. Meal Replacement Provides Additional Benefits for Weight and Visceral Fat Reduction in Prediabetic Individuals: A Randomized Clinical Trial. J Nutr Metab. 2026 Aug 24;2026:7109903. doi: 10.1155/jnme/7109903. eCollection 2026.
PubMed 42639295
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Supplements (Ivital Control) on Clinical Outcomes in Patients With Prediabetes and Obesity：a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05273840
- Acronym / sponsor ID
- 2021-R037
- Conditions
- PreDiabetes, Obesity
- Keywords
- PreDiabetes, Obesity, Glycosylated hemoglobin, weight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 10 Mar 2022 (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.
This study aims to improve blood glucose and weight in patients with prediabetes and obesity through health education, nutritional supplement interventions, clinical evaluation, and close clinical follow-up.100 patients with prediabetes with obesity were randomly divided into 2 groups: life intervention group, nutritional supplement intervention group. All enrolled participants were recommended for routine diabetes lifestyle education according to the "Expert Consensus on Prediabetes Intervention in Adults in China". The duration of the intervention was 3 months. The investigators aimed to compare the differences in weight, glycosylated hemoglobin, lipids and other indicators of the two groups of included populations before and after the intervention. In addition, the investigators are to explore the effects of nutritional supplement interventions on glycolipid metabolism and body weight in prediabetes with obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. life intervention group 2. nutritional supplement intervention group
| Arm | Type | Receives |
|---|---|---|
| life intervention group | Placebo comparator | Behavioral: lifestyle interventionOn the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given to the patients until the end of the visit. |
| nutritional supplement intervention group | Experimental | Dietary Supplement: Ivital ControlOn the basis of the patient's original eating habits, basic dietary and lifestyle guidance is given, and at the same time, nutritional supplements(Ivital Control) are given to instead a meal per day. 2 bags once a day until the end of the visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- According to the American Diabetes Society (ADA) 2010 standard: meet one of the following (1) fasting blood glucose at 100 mg/dl to 125 mg/dl; (2) sugar load 2h blood glucose at 140 mg/dl to 199 mg/dl; (3) glycosylated hemoglobin in 5.7% to 6.4%
- Body mass index (BMI) ≥ 25 and ≤ 35kg/m2
- Have lived locally for at least half a year and have a fixed residence
- No other clinical trials were participated in in the 3 months prior to the trial
- Mental health, being able to take care of oneself in life
Key exclusion criteria (8 listed)
- People with confirmed diabetes
- Weight change of more than 10% over the past 3 months
- Pregnant or lactating women, men and women planning to become pregnant within two years, or unwilling and unable to use contraception during the study period (women only)
- People who are allergic to the ingredients of nutritional supplements
- Those who have lost weight by any medication (including appetite suppressants such as fluprophenylpropanine, progesterone, laxatives, etc., and diet pills with various Traditional Chinese medicine ingredients) or surgery in the past 3 months
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 |
|---|---|---|
| Ivital ControlAlso: Produced by Fresenius Kabi, Chocolate flavor, Product specifications: 460g (46g*10)Patients in the intervention group will take 2 sachets of nutritional supplements(Ivital Control) once a day in lieu of one meal, besides receiving lifestyle interventions. | Dietary supplement | nutritional supplement intervention group |
| lifestyle interventionPatients will receive lifestyle interventions. | Behavioural | life intervention group |
Primary outcome
the proportions of participants regressing back to normal glucose level
Time frame: 3 months
The normal glucose level was defined as FPG < 6.1 mmol/L and 2hPG < 7.8 mmol/L during the OGTT.
2 secondary outcomes
change in HbA1c
Time frame: 3 months
body weight
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Derived from this study: PubMed 42639295Zhou Y, Jin L, Zhang P, Li Y, Jin Y, Xu M, Song Q, Li L. Meal Replacement Provides Additional Benefits for Weight and Visceral Fat Reduction in Prediabetic Individuals: A Randomized Clinical Trial. J Nutr Metab. 2026 Aug 24;2026:7109903. doi: 10.1155/jnme/7109903. eCollection 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention in people with PreDiabetes and Obesity, run by Ningbo No. 1 Hospital at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Jun 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Li, Bachelor of Medicine degree (8613757426626, lilyningbo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportions of participants regressing back to normal glucose level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273840, which also lists 1 linked publication.
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 9 Jun 2022.