An interventional study of refined carbohydrate breakfast and whole grain breakfast in Healthy and Overweight and Obesity, sponsored by Westlake University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Westlake University · Not applicable, Interventional, and Prevention
This is a dietary intervention study, which aims to explore different diet challenges for glucose metabolism, including carbohydrates and intermittent fasting (IF) dietary pattern. Considering the glucose responses to the same food are largely heterogeneous among people, this study integrates the concepts of precision nutrition and N-of-1 design. The study also aims to explore differences in brain structure and function between participants with different Body Mass Index (BMI) from the perspective of gut-brain axis.
This study aims for precision nutrition. Participants will be required to wear continuous glucose monitoring (CGM) for 14 days. The diet intervention will be carried out after wearing CGM on Day 1. Individual N-of-1 trial design will be employed during Day 2 to Day 7 to compare the difference of postprandial glucose response to white bread or plain oats. These two breakfasts will appear in alternating order every successive 2 days, and these successive 2 days will be defined as one set. There will be 3 sets during Day 2 to Day 7. Between lunch and dinner will be the wash out period for the remaining effect of the last breakfast intervention on blood glucose homeostasis. In this period, participants will be allowed to choose foods without restrictions, but dietary records are required. The period during Day 8 to Day 14 is defined as intermittent fasting (IF) period, and participants will experience moderate fasting on Day 9 and Day 13 with total energy intake restrained within 500-600 kcal. In these two fasting days, participants will be provided with daily three meals. Investigators will closely monitor participants' latent adverse response and compliance to ensure the intervention will be completed with adequate safety and high compliancy. Oral glucose tolerance test (OGTT) will be conducted in the morning of Day 8 and Day 14 to test the changes of glucose tolerance before and after one set of IF intervention. Electroencephalogram (EEG) and functional Magnetic Resonance Imaging (fMRI) scanning will be conducted as per standard procedure at baseline.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 176 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Westlake University is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
white bread (50g) + milk powder (25g)
Other: refined carbohydrate breakfast
plain oats (35g) + milk powder (25g)
Other: whole grain breakfast
Other: intermittent fasting
After wearing CGM on Day 1, participants will be provided with breakfast A once daily on Day 2, Day 5 and Day 6. Breakfast A contains white bread (50g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets.
Also known as: Breakfast A
After wearing CGM on Day 1, participants will be provided with Breakfast B once daily on Day 3, Day 4 and Day 7. Breakfast B contains plain oats (35g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets.
Also known as: Breakfast B
The period during Day 8 to Day 13 is intermittent fasting period. Participants will experience the moderate fasting on Day 9 and Day 12, which means their daily energy intake is expected to be controlled within 500-600 kcal limit. In these two days, participants will be provided with all three meals. Percentages of macronutrients of provided meals will follow the Recommended Dietary Health guidelines for Chinese residents. The oral glucose tolerance test (OGTT) will be conducted in the morning on Day 8 and Day 13, to test short-term impact of IF intervention on individuals' glucose tolerance. The breakfasts on Day 10 and Day 11 will be the same as that in fasting days. Other meals will be wash-out meals.
Also known as: IF
Blood glucose profiling
Real-time blood glucose fluctuations will be recorded by CGM.
Time frame: 14 days
Change of glucose tolerance before and after intermittent fasting
Oral glucose tolerance test will also be conducted.
Time frame: Day 8 and Day 13
Changes of fecal and urine metabolomics profiling
Fecal and urine metabolite extracts will be analyzed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).
Time frame: Day 1, Day 8 , Day 11 and Day 14
Changes of serum metabolomics profiling
Targeted metabolomics are analyzed based on serum.
Time frame: Day 1, and Day 14
Changes of interleukin-1β (IL-1β), IL-6, IL-12
Serum inflammatory factors (including IL-1β, IL-6, and IL-12) will be tested by enzyme-linked immunosorbent assay (ELISA) in pg/mL.
Time frame: Day 1, and Day 14
Changes of tumor necrosis factor-α (TNF-α)
Serum level of TNF-α will be tested by ELISA in ng/mL.
Time frame: Day 1, and Day 14
Changes of serum dopamine
Dopamine will be analyzed by serum.
Time frame: Day 1, and Day 14
Changes of serum 5-hydroxytryptamine
5- hydroxytryptamine will be analyzed by serum.
Time frame: Day 1, and Day 14
Changes of serum gamma-aminobutyric acid
Gamma-aminobutyric acid will be analyzed by serum.
Time frame: Day 1, and Day 14
Changes of lipid metabolism
Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B.
Time frame: Day 1, and Day 14
Changes of weight
Weight will be measured in kilograms.
Time frame: Day 1, Day 8 , Day 11 and Day 14
Height
Height will be measured in centimeters.
Time frame: Day 1
Body composition
Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.
Time frame: at enrollment
Changes of both systolic and diastolic blood pressure
Both systolic and diastolic blood pressure will be measured in mmHg.
Time frame: Day 1, Day 8 , Day 11 and Day 14
Electroencephalograph(EEG) N2 and P3 amplitudes
Event-related potentials (N2 and P3 amplitudes) of brain will be assessed by EEG in μV.
Time frame: at enrollment
Brain images
Brain structure and function was measured by brain magnetic resonance imaging (MRI)
Time frame: at enrollment
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Westlake University