Impaired Glucose RegulationNCT06475573
Fermented Dietary Fiber and Probiotics on Overweight/Obese Patients
A study testing dietary fiber probiotic beverages and whole grain porridge in people with Impaired Glucose Regulation and Overweight and Obesity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Impaired Glucose Regulation, Overweight and Obesity
- What is being tested?
- dietary fiber probiotic beverages and whole grain porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Oct 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old
- Meet the criteria for impaired glucose regulation according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)":
- IFG: Fasting blood glucose ≥ 6.1 mmol/L and < 7.0 mmol/L IGT: 2-hour postprandial glucose ≥ 7.8 mmol/L and < 11.1 mmol/L
- Meet the Asia-Pacific criteria for overweight and obesity: 23 kg/m2 ≤ BMI
- Signed informed consent
Who cannot join
- Patients diagnosed with diabetes or currently undergoing diabetes treatment
- Patients who have received weight loss medication or surgery in the past 3 months
- Patients who are taking corticosteroids or thyroid hormones
- Patients with secondary obesity caused by endocrine, genetic, metabolic, or central nervous system diseases
- Patients with severe liver function or abnormal kidney function
- Patients with diseases that affect food digestion and absorption
Show all 10Show fewer
- Patients with cardiovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy, etc.
- Patients with active tuberculosis, AIDS, and other infectious diseases
- Pregnant or breastfeeding women
- Patients with limb disabilities or other conditions that the clinical investigator deems inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Effect of Fermented Dietary Fiber and Probiotics on the Intervention of Overweight/Obese Patients With Impaired Glucose Regulation
This study aims to investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals.
Read the detailed description
Impaired glucose regulation (IGR), encompassing impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), represents a crucial stage in the progression to type 2 diabetes. Characterized by a state of compensatory glucose dysmetabolism, IGR is closely linked to overweight/obesity and can be reversed through lifestyle interventions. Timely intervention during this stage can promote weight loss, delay or prevent the onset and development of diabetes, and reduce the risk of cardiovascular diseases, chronic kidney disease, and all-cause mortality.
Current treatment approaches for overweight/obese IGR patients include dietary and physical activity modifications, pharmacotherapy, and bariatric surgery. However, individual responses to these interventions vary considerably. Dietary fiber, essential for maintaining normal gastrointestinal function, has been associated with an increased risk of various diseases, including colorectal cancer, cardiovascular diseases, obesity, metabolic syndrome, and type 2 diabetes, when consumed in inadequate amounts. Conversely, the gut microbiota plays a pivotal role in diabetes development and progression. Probiotics, potentially through the stimulation of short-chain fatty acid production and the induction of gut hormone secretion that influences blood glucose levels, may exert beneficial effects by enhancing immune modulation, increasing anti-inflammatory cytokine production, reducing intestinal permeability, and mitigating oxidative stress.
Therefore, this study aims to investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals.
- Being tested
- dietary fiber probiotic beverages, whole grain porridge
- Keywords
- impaired fasting glucose, impaired glucose tolerance, overweight and obesity, dietary fiber, Probiotic
- Medical subject headings
- Overweight, Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fiber probiotic beveragesDietary supplement
The intervention period lasted for 8 weeks. During this time, Participants received dietary guidance from researchers. The target energy intake was based on the limited energy diet model recommended in the "Chinese Guidelines for Medical Nutrition Therapy of Overweight/Obesity (2021)". Carbohydrates were to account for 55%-60% and fat for 25%-30% of total daily energy intake. Participants in experimental group consumed two 35g sachets of fermented dietary fiber probiotic solid beverages daily, replacing part of the staple food for lunch and dinner.
whole grain porridgeOther
The intervention period lasted for 8 weeks. During this time, Participants received dietary guidance from researchers. The target energy intake was based on the limited energy diet model recommended in the "Chinese Guidelines for Medical Nutrition Therapy of Overweight/Obesity (2021)".Participants in control group consumed two 35g sachets of convenient whole grain porridge daily, replacing part of the staple food for lunch and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Consume two 35g sachets of fermented dietary fiber probiotic solid beverages daily, replacing part of the staple food for lunch and dinner. Receives: Dietary Supplement: dietary fiber probiotic beverages |
| Control Group | Active comparator | Consume two 35g sachets of convenient whole grain porridge daily, replacing part of the staple food for lunch and dinner. Receives: Other: whole grain porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose
fasting blood glucose after an overnight fast
Measured: Baseline and after 8-week intervention
2-hour postprandial blood glucose
2-hour postprandial blood glucose after 75g Glucose Tolerance Test
Measured: Baseline and after 8-week intervention
Secondary outcomes (3)
Body weight
Body weight
Measured: Baseline; after 4-week intervention; after 8-week intervention
body composition
body composition measured by Bioelectrical impedance analysis, including body fat percentage, visceral fat area, skeletal muscle mass
Measured: Baseline; after 4-week intervention; after 8-week intervention
Lipid profile
Total cholesterol, triglycerides, HDL, LDL
Measured: Baseline and after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Mar 2023
- Primary completion31 May 2024
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose RegulationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pianhong Zhang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475573
- Sponsor's protocol ID
- 2022-0946
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fermented Dietary Fiber and Probiotics on the Intervention of Overweight/Obese Patients With Impaired Glucose Regulation
- ClinicalTrials.gov ID
- NCT06475573
- Acronym / sponsor ID
- 2022-0946
- Keywords
- impaired fasting glucose, impaired glucose tolerance, overweight and obesity, dietary fiber, Probiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 26 Jun 2024 (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 investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals.
Detailed description
Impaired glucose regulation (IGR), encompassing impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), represents a crucial stage in the progression to type 2 diabetes. Characterized by a state of compensatory glucose dysmetabolism, IGR is closely linked to overweight/obesity and can be reversed through lifestyle interventions. Timely intervention during this stage can promote weight loss, delay or prevent the onset and development of diabetes, and reduce the risk of cardiovascular diseases, chronic kidney disease, and all-cause mortality.
Current treatment approaches for overweight/obese IGR patients include dietary and physical activity modifications, pharmacotherapy, and bariatric surgery. However, individual responses to these interventions vary considerably. Dietary fiber, essential for maintaining normal gastrointestinal function, has been associated with an increased risk of various diseases, including colorectal cancer, cardiovascular diseases, obesity, metabolic syndrome, and type 2 diabetes, when consumed in inadequate amounts. Conversely, the gut microbiota plays a pivotal role in diabetes development and progression. Probiotics, potentially through the stimulation of short-chain fatty acid production and the induction of gut hormone secretion that influences blood glucose levels, may exert beneficial effects by enhancing immune modulation, increasing anti-inflammatory cytokine production, reducing intestinal permeability, and mitigating oxidative stress.
Therefore, this study aims to investigate the efficacy of fermented dietary fiber and probiotics in improving glycemic control and associated metabolic parameters in overweight/obese IGR patients. The ultimate goal is to establish a clinically applicable nutrition intervention strategy for glucose tolerance impaired individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: dietary fiber probiotic beveragesConsume two 35g sachets of fermented dietary fiber probiotic solid beverages daily, replacing part of the staple food for lunch and dinner. |
| Control Group | Active comparator | Other: whole grain porridgeConsume two 35g sachets of convenient whole grain porridge daily, replacing part of the staple food for lunch and dinner. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years old
- Meet the criteria for impaired glucose regulation according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)":
- IFG: Fasting blood glucose ≥ 6.1 mmol/L and < 7.0 mmol/L IGT: 2-hour postprandial glucose ≥ 7.8 mmol/L and < 11.1 mmol/L
- Meet the Asia-Pacific criteria for overweight and obesity: 23 kg/m2 ≤ BMI
- Signed informed consent
Key exclusion criteria (10 listed)
- Patients diagnosed with diabetes or currently undergoing diabetes treatment
- Patients who have received weight loss medication or surgery in the past 3 months
- Patients who are taking corticosteroids or thyroid hormones
- Patients with secondary obesity caused by endocrine, genetic, metabolic, or central nervous system diseases
- Patients with severe liver function or abnormal kidney function
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 |
|---|---|---|
| dietary fiber probiotic beveragesThe intervention period lasted for 8 weeks. During this time, Participants received dietary guidance from researchers. The target energy intake was based on the limited energy diet model recommended in the "Chinese Guidelines for Medical Nutrition Therapy of Overweight/Obesity (2021)". Carbohydrates were to account for 55%-60% and fat for 25%-30% of total daily energy intake. Participants in experimental group consumed two 35g sachets of fermented dietary fiber probiotic solid beverages daily, replacing part of the staple food for lunch and dinner. | Dietary supplement | Experimental group |
| whole grain porridgeThe intervention period lasted for 8 weeks. During this time, Participants received dietary guidance from researchers. The target energy intake was based on the limited energy diet model recommended in the "Chinese Guidelines for Medical Nutrition Therapy of Overweight/Obesity (2021)".Participants in control group consumed two 35g sachets of convenient whole grain porridge daily, replacing part of the staple food for lunch and dinner. | Other | Control Group |
Primary outcome
fasting blood glucose
Time frame: Baseline and after 8-week intervention
fasting blood glucose after an overnight fast
2-hour postprandial blood glucose
Time frame: Baseline and after 8-week intervention
2-hour postprandial blood glucose after 75g Glucose Tolerance Test
3 secondary outcomes
Body weight
Time frame: Baseline; after 4-week intervention; after 8-week intervention
body composition
Time frame: Baseline; after 4-week intervention; after 8-week intervention
Lipid profile
Time frame: Baseline and after 8-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
Related trials for Impaired Glucose Regulation
Recruiting
Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation
Impaired Glucose Regulation, Impaired Glucose Tolerance (Prediabetes)
Not yet recruiting
Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control
Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus
Not yet recruitingPhase 4
Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)
Prediabetes, Impaired Fasting Glucose
Active, not recruiting
Time Restricted Eating on Impaired Glucose Regulation(TRIG Trial)
Impaired Glucose Regulation, Overweight/Obese
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.
Pianhong Zhang, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary fiber probiotic beverages and whole grain porridge in people with Impaired Glucose Regulation and Overweight and Obesity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. 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. 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?
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?
fasting blood glucose (time frame: Baseline and after 8-week intervention). The study lists 2 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 26 Jun 2024.