Effect of Nutritional Supplements on Clinical Outcomes in Patients With Prediabetes and Obesity

NCT ID: NCT05273840

Last Updated: 2022-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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PreDiabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. life intervention group
2. nutritional supplement intervention group
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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life intervention group

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.

Group Type PLACEBO_COMPARATOR

lifestyle intervention

Intervention Type BEHAVIORAL

Patients will receive lifestyle interventions.

nutritional supplement intervention group

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.

Group Type EXPERIMENTAL

Ivital Control

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Ivital Control

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.

Intervention Type DIETARY_SUPPLEMENT

lifestyle intervention

Patients will receive lifestyle interventions.

Intervention Type BEHAVIORAL

Other Intervention Names

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Produced by Fresenius Kabi Chocolate flavor Product specifications: 460g (46g*10)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ningbo First Hospital

Ningbo, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Li, Bachelor of Medicine degree

Role: CONTACT

8613757426626

Facility Contacts

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Li Li

Role: primary

Other Identifiers

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2021-R037

Identifier Type: -

Identifier Source: org_study_id

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