Metabolic DiseaseProGNCT06525441
Dietary Protein Sources and Glycemic Variability
A study testing Plant-based Diet and Animal-based Diet in people with Metabolic Disease and Diabetes, run by Guangdong Provincial People's Hospital.
Trial summary
This goal of trial is to evaluate the effects of plant-based vs. animal-based diets on glycemic variability in overweight or obese adults through a 3-week dietary intervention. The main question it aims to answer is: Will a plant-based diet be able to reduce glycemic variability in overweight or obese adults compared… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Diabetes, Overweight
- What is being tested?
- Plant-based Diet and Animal-based Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Feb 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged 20-65 years.
- Body Mass Index (BMI) greater than 25kg/m2.
- Capable of using a smartphone application daily for taking photos and recording dietary intake.
- Maintained stable body weight over the past three months with a regular routine.
- Possess self-care ability for independent living.
- Not currently participating in any other clinical research projects.
- Signed the informed consent form and willing to adhere to and complete the entire research process.
Who cannot join
- With diagnosed diabetes.
- With severe cardiovascular or cerebrovascular diseases (e.g., angina, myocardial infarction, or stroke) or cancer.
- Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician.
- Participating in weight loss treatments.
- History of severe gastrointestinal diseases or gastrointestinal surgery within the past 12 months.
- Those with allergic reactions to common foods (for example, eggs, nuts, grains) or those who are lactose intolerant.
Show all 10Show fewer
- Women who are pregnant or plan to become pregnant.
- Diagnosis of HIV, hepatitis B or C, or active tuberculosis.
- Special groups who are specifically unsuitable for a diet consisting of whole plant proteins.
- Patients who are unwilling or unable to give informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Dietary Protein Sources on Glycemic Variability in Overweight or Obese Individuals: a Randomized Controlled Trial
This goal of trial is to evaluate the effects of plant-based vs. animal-based diets on glycemic variability in overweight or obese adults through a 3-week dietary intervention.
The main question it aims to answer is:
Will a plant-based diet be able to reduce glycemic variability in overweight or obese adults compared with an animal-based diet?
Participants will strictly follow a designated plant-based or animal-based dietary regimen throughout the duration of the 3-week study. They will wear a Continuous Glucose Monitor (CGM) throughout the study, engage in weekly clinical assessments, and record their daily dietary intake.
Read the detailed description
Diabetes stands as one of the most rapidly escalating health challenges of the 21st century. Type 2 diabetes, which represents over 90% of all diagnosed cases, is the predominant form of the disease, with obesity and being overweight identified as key risk factors. The mainstay of prevention and management for Type 2 diabetes continues to be dietary intervention and nutritional therapy. Current dietary strategies for Type 2 diabetes focus predominantly on the regulation of fat and carbohydrate intake, while the influence and underlying mechanisms of dietary protein on glucose metabolism are not yet fully comprehended.
A randomized, open-label, parallel-controlled clinical trial, by strictly controlling the source of protein, will be performed to evaluate the effects of a plant-based diet on glycemic variability and other metabolic outcomes in individuals who are overweight or obese, in comparison to an animal-based diet. Eligible participants will be randomly allocated in a 1:1 ratio to either the plant-based or animal-based diet group for a 3-week intervention.
During the intervention, participants in the plant-based diet group will receive three daily meals for three weeks.Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The primary sources of plant protein will include soybeans, lentils, nuts, grains, and seaweed. Conversely, the animal-based diet group will also be provided with three daily meals for three weeks, with the same caloric distribution, but sourcing their protein from animal products such as poultry, beef, pork, fish, eggs, and dairy.
Participants are required to cooperate in completing the following tasks:
- Daily dietary record: Participants are to meticulously track their daily food consumption.
- Continuous 24-hour glucose monitoring and data logging: Subjects are to undergo continuous monitoring of blood glucose levels throughout a 24-hour period, with all data accurately recorded.
- Physical examination: This will include assessments of height, weight, waist-to-hip circumference ratio, blood pressure, and body composition.
- Biological sample collection: Samples to be collected include blood, urine, and stool.
The timing for physical examinations and biological sample collections is scheduled as follows: Day 5 ± 2 of the introduction phase, Week 1 ± 2 days of the intervention phase, Week 2 ± 2 days of the intervention phase, and Week 3 ± 2 days of the intervention phase.
Dietary and health counseling will be consistently available throughout the study to provide participants with continuous support and guidance.
- Conditions
- Metabolic Disease, Diabetes, Overweight, Obesity, Dietary Protein
- Being tested
- Plant-based Diet, Animal-based Diet
- Medical subject headings
- Metabolic Diseases, Diabetes Mellitus, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based DietOther
Participants assigned to the plant-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The main dietary sources of plant protein will be soybeans, flat beans, nuts, grains, and algae.
Animal-based DietOther
Participants assigned to the animal-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from animal protein, and 25% from fat. The main dietary sources of animal protein will be chicken, beef, pork, fish, eggs, and dairy products.
| Study group | Role | What they receive |
|---|---|---|
| Plant-based diet | Experimental | Participants assigned to the plant-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The main dietary sources of plant protein will be soybeans, flat beans, nuts, grains, and algae. Receives: Other: Plant-based Diet |
| Animal-based diet | Active comparator | Participants assigned to the animal-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from animal protein, and 25% from fat. The main dietary sources of animal protein will be chicken, beef, pork, fish, eggs, and dairy products. Receives: Other: Animal-based Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Amplitude of Glycemic Excursion (MAGE)
Continuous Glucose Monitoring (CGM) will measure the Mean Amplitude of Glycemic Excursion (MAGE).
Measured: From enrollment to the end of intervention at 3 weeks
Secondary outcomes (21)
Change in fasting blood-glucose
Measured: From enrollment to the end of intervention at 3 weeks
Change in fasting insulin
Measured: From enrollment to the end of intervention at 3 weeks
Change in mean glucose levels
Measured: From enrollment to the end of intervention at 3 weeks
Change in total daily time above range
>7.8 mmol/L
Measured: From enrollment to the end of intervention at 3 weeks
Change in total daily time below range
<3.9 mmol/L
Measured: From enrollment to the end of intervention at 3 weeks
Change in range of total daily time
3.9 ~7.8 mmol/L
Measured: From enrollment to the end of intervention at 3 weeks
Change in glycemic variability
Measured: From enrollment to the end of intervention at 3 weeks
Change in glycemic standard deviation
Measured: From enrollment to the end of intervention at 3 weeks
Change in insulin sensitivity
Measured: From enrollment to the end of intervention at 3 weeks
Change in β cell function
Measured: From enrollment to the end of intervention at 3 weeks
Change in Large Amplitude of Glycemic Excursions (LAGE)
Measured: From enrollment to the end of intervention at 3 weeks
Change in Area Under Curve (AUC)
Measured: From enrollment to the end of intervention at 3 weeks
Change in body weight
Measured: From enrollment to the end of intervention at 3 weeks
Change in waist-to-hip ratio
Measured: From enrollment to the end of intervention at 3 weeks
Change in body composition
Measured: From enrollment to the end of intervention at 3 weeks
Change in blood lipids
Measured: From enrollment to the end of intervention at 3 weeks
Change in uric acid
Measured: From enrollment to the end of intervention at 3 weeks
Change in gut microbiome
Measured: From enrollment to the end of intervention at 3 weeks
Change in renal function
Measured: From enrollment to the end of intervention at 3 weeks
Change in systolic blood pressure
Measured: From enrollment to the end of intervention at 3 weeks
Change in diastolic blood pressure
Measured: From enrollment to the end of intervention at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Li, Guangdong Provincial People's Hospital
- Investigators
- Jie Li, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525441
- Sponsor's protocol ID
- KY2024-501-03
- Acronym
- ProG
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 31 Jul 2024
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Protein Sources on Glycemic Variability in Overweight or Obese Individuals: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06525441
- Acronym / sponsor ID
- ProG / KY2024-501-03
- Conditions
- Metabolic Disease, Diabetes, Overweight, Obesity, Dietary Protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 29 Jul 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 goal of trial is to evaluate the effects of plant-based vs. animal-based diets on glycemic variability in overweight or obese adults through a 3-week dietary intervention.
The main question it aims to answer is:
Will a plant-based diet be able to reduce glycemic variability in overweight or obese adults compared with an animal-based diet?
Participants will strictly follow a designated plant-based or animal-based dietary regimen throughout the duration of the 3-week study. They will wear a Continuous Glucose Monitor (CGM) throughout the study, engage in weekly clinical assessments, and record their daily dietary intake.
Detailed description
Diabetes stands as one of the most rapidly escalating health challenges of the 21st century. Type 2 diabetes, which represents over 90% of all diagnosed cases, is the predominant form of the disease, with obesity and being overweight identified as key risk factors. The mainstay of prevention and management for Type 2 diabetes continues to be dietary intervention and nutritional therapy. Current dietary strategies for Type 2 diabetes focus predominantly on the regulation of fat and carbohydrate intake, while the influence and underlying mechanisms of dietary protein on glucose metabolism are not yet fully comprehended.
A randomized, open-label, parallel-controlled clinical trial, by strictly controlling the source of protein, will be performed to evaluate the effects of a plant-based diet on glycemic variability and other metabolic outcomes in individuals who are overweight or obese, in comparison to an animal-based diet. Eligible participants will be randomly allocated in a 1:1 ratio to either the plant-based or animal-based diet group for a 3-week intervention.
During the intervention, participants in the plant-based diet group will receive three daily meals for three weeks.Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The primary sources of plant protein will include soybeans, lentils, nuts, grains, and seaweed. Conversely, the animal-based diet group will also be provided with three daily meals for three weeks, with the same caloric distribution, but sourcing their protein from animal products such as poultry, beef, pork, fish, eggs, and dairy.
Participants are required to cooperate in completing the following tasks:
- Daily dietary record: Participants are to meticulously track their daily food consumption.
- Continuous 24-hour glucose monitoring and data logging: Subjects are to undergo continuous monitoring of blood glucose levels throughout a 24-hour period, with all data accurately recorded.
- Physical examination: This will include assessments of height, weight, waist-to-hip circumference ratio, blood pressure, and body composition.
- Biological sample collection: Samples to be collected include blood, urine, and stool.
The timing for physical examinations and biological sample collections is scheduled as follows: Day 5 ± 2 of the introduction phase, Week 1 ± 2 days of the intervention phase, Week 2 ± 2 days of the intervention phase, and Week 3 ± 2 days of the intervention phase.
Dietary and health counseling will be consistently available throughout the study to provide participants with continuous support and guidance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-based diet | Experimental | Other: Plant-based DietParticipants assigned to the plant-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The main dietary sources of plant protein will be soybeans, flat beans, nuts, grains, and algae. |
| Animal-based diet | Active comparator | Other: Animal-based DietParticipants assigned to the animal-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from animal protein, and 25% from fat. The main dietary sources of animal protein will be chicken, beef, pork, fish, eggs, and dairy products. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged 20-65 years.
- Body Mass Index (BMI) greater than 25kg/m2.
- Capable of using a smartphone application daily for taking photos and recording dietary intake.
- Maintained stable body weight over the past three months with a regular routine.
- Possess self-care ability for independent living.
Key exclusion criteria (10 listed)
- With diagnosed diabetes.
- With severe cardiovascular or cerebrovascular diseases (e.g., angina, myocardial infarction, or stroke) or cancer.
- Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician.
- Participating in weight loss treatments.
- History of severe gastrointestinal diseases or gastrointestinal surgery within the past 12 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 |
|---|---|---|
| Plant-based DietParticipants assigned to the plant-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from plant protein, and 25% from fat. The main dietary sources of plant protein will be soybeans, flat beans, nuts, grains, and algae. | Other | Plant-based diet |
| Animal-based DietParticipants assigned to the animal-based diet group will be provided three meals daily for 3 weeks. Of the energy of each meal, 60% is from carbohydrates, 15% from animal protein, and 25% from fat. The main dietary sources of animal protein will be chicken, beef, pork, fish, eggs, and dairy products. | Other | Animal-based diet |
Primary outcome
Change in Mean Amplitude of Glycemic Excursion (MAGE)
Time frame: From enrollment to the end of intervention at 3 weeks
Continuous Glucose Monitoring (CGM) will measure the Mean Amplitude of Glycemic Excursion (MAGE).
21 secondary outcomes
Change in fasting blood-glucose
Time frame: From enrollment to the end of intervention at 3 weeks
Change in fasting insulin
Time frame: From enrollment to the end of intervention at 3 weeks
Change in mean glucose levels
Time frame: From enrollment to the end of intervention at 3 weeks
Change in total daily time above range
Time frame: From enrollment to the end of intervention at 3 weeks
Change in total daily time below range
Time frame: From enrollment to the end of intervention at 3 weeks
Change in range of total daily time
Time frame: From enrollment to the end of intervention at 3 weeks
Change in glycemic variability
Time frame: From enrollment to the end of intervention at 3 weeks
Change in glycemic standard deviation
Time frame: From enrollment to the end of intervention at 3 weeks
Change in insulin sensitivity
Time frame: From enrollment to the end of intervention at 3 weeks
Change in β cell function
Time frame: From enrollment to the end of intervention at 3 weeks
Change in Large Amplitude of Glycemic Excursions (LAGE)
Time frame: From enrollment to the end of intervention at 3 weeks
Change in Area Under Curve (AUC)
Time frame: From enrollment to the end of intervention at 3 weeks
Change in body weight
Time frame: From enrollment to the end of intervention at 3 weeks
Change in waist-to-hip ratio
Time frame: From enrollment to the end of intervention at 3 weeks
Change in body composition
Time frame: From enrollment to the end of intervention at 3 weeks
Change in blood lipids
Time frame: From enrollment to the end of intervention at 3 weeks
Change in uric acid
Time frame: From enrollment to the end of intervention at 3 weeks
Change in gut microbiome
Time frame: From enrollment to the end of intervention at 3 weeks
Change in renal function
Time frame: From enrollment to the end of intervention at 3 weeks
Change in systolic blood pressure
Time frame: From enrollment to the end of intervention at 3 weeks
Change in diastolic blood pressure
Time frame: From enrollment to the end of intervention at 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Metabolic Disease
Not yet recruitingEarly Phase 1
Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas
Glioma
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingPhase 1
A Study of Single Ascending Doses of NI112 in Adults With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
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.
Jie Li principal investigator
Guangdong Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based Diet and Animal-based Diet in people with Metabolic Disease and Diabetes, run by Guangdong Provincial People's Hospital.
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 7 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Juncheng Zhuang (+86-020-33971424, zhuangjuncheng@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Amplitude of Glycemic Excursion (MAGE) (time frame: From enrollment to the end of intervention at 3 weeks). 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 31 Jul 2024.