Dietary Protein Sources and Glycemic Variability
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorGuangdong Provincial People's Hospital
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Plant-based Diet
Other interventionParticipants 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
Other interventionParticipants 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.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Plant-based dietExperimental treatment 1 intervention
Group B: Animal-based dietActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Mean Amplitude of Glycemic Excursion (MAGE)
Continuous Glucose Monitoring (CGM) will measure the Mean Amplitude of Glycemic Excursion (MAGE).
Time frame
From enrollment to the end of intervention at 3 weeksSecondary outcomes
1
Change in fasting blood-glucose
Time frame
From enrollment to the end of intervention at 3 weeks2
Change in fasting insulin
Time frame
From enrollment to the end of intervention at 3 weeks3
Change in mean glucose levels
Time frame
From enrollment to the end of intervention at 3 weeks4
Change in total daily time above range
\>7.8 mmol/L
Time frame
From enrollment to the end of intervention at 3 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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