The aim of this study was to investigate the changes in visceral fat area and associated indicators in individuals with high body fat percentage under the intervention of barley green, elucidate the clinical efficacy of barley green on human visceral fat, and preliminarily explore the mechanism by which barley green influences human visceral fat through gut microbiota analysis. Participants with high body fat percentage were recruited from the Clinical Nutrition Department of Peking University People's Hospital and randomly assigned to either an intervention group or a control group. The intervention group received a regimen combining barley green supplementation with a calorie-restricted balanced diet plan, while the control group followed only the calorie-restricted balanced diet plan. General clinical data were collected, nutritional assessments were conducted, and dynamic analyses of body composition and metabolism were performed. Venous blood samples were obtained for the measurement of metabolic and inflammation-related indices as well as gut microbiota characterization. By observing and comparing differences in visceral fat area and related parameters, as well as gut microbiota profiles between the two groups, this study provides a scientific foundation for the clinical application of barley green in medical nutrition interventions targeting populations with high body fat percentage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Oral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day
Peking University People's Hospital
Beijing, Xicheng District, China
RECRUITINGvisceral fat area in cm2
Visceral fat areas are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks.
height in centimeters
Height in centimeters are measured by Manual Height Ruler at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
weight in kilograms
Weight in kilograms are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
BMI in kg/m^2
Weight and height will be combined to report BMI in kg/m\^2 at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
body fat rate in %
Body fat rates are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
muscle mass in kilograms
Muscle masses are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
basal metabolic rate in kcal
Basal metabolic rates are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
skeletal muscle mass in kilograms
Skeletal muscle masses are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
blood pressure in mmHg
Blood pressures are measured by electronic blood pressure monitor at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
waist circumference in millimeters
Waist circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
hip circumference in millimeters
Hip circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
upper arm circumference in millimeters
Upper arm circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
left hand grip strength in pound-force
Left hand grip strengths are measured by grip dynamometer at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
right hand grip strength in pound-force
Right hand grip strengths are measured by grip dynamometer at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
triceps skinfold thickness in millimeters
Triceps skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
subscapular horn skinfold thickness in millimeters
Subscapular horn skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
abdominal skinfold thickness in millimeters
Abdominal skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
food intake dose in grams
Data of food intake doses are taken by food frequency questionnaire and 3-day food diary at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
uric acid levels in umol/L
Uric acid levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
blood glucose in mmol/L
Blood glucose levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
total cholesterol in mmol/L
Total cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
triglycerides in mmol/L
Triglycerides levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
high-density lipoprotein cholesterol in mmol/L
High-density lipoprotein cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
low-density lipoprotein cholesterol in mmol/L
Low-density lipoprotein cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
white blood cell count in 10^9/L
White blood cell counts are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
hemoglobin in g/L
Hemoglobin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
glutamic-pyruvic transaminase in U/L
Glutamic-pyruvic transaminase levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
glutamic oxalacetic transaminase in U/L
Glutamic oxalacetic transaminase levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
albumin in g/L
Albumin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin B6 in ng/mL
Vitamin B6 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin B1 in ng/mL
Vitamin B1 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin B9 in ng/mL
Vitamin B9 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin B5 in ng/mL
Vitamin B5 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin B3 in ng/mL
Vitamin B3 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin B2 in ng/mL
Vitamin B2 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin B12 in ng/mL
Vitamin B12 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin A in ng/mL
Vitamin A levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin D in ng/mL
Vitamin D levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin E in ng/mL
Vitamin E levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
vitamin K in ng/mL
Vitamin K levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
cobalt in µg/L
Cobalt levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
nickel in µg/L
Nickel levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
selenium in µg/L
Selenium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
arsenic in µg/L
Arsenic levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
platinum in µg/L
Platinum levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
copper in mg/L
Copper levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
molybdenum in µg/L
Molybdenum levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
zinc in mg/L
Zinc levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
manganese in µg/L
Manganese levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
magnesium in mg/L
Magnesium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
cadmium in µg/L
Cadmium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
iron in mg/L
Iron levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
thallium in µg/L
Thallium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
lead in µg/L
Lead levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
calcium in mg/L
Calcium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
cortisol in µg/dL
Cortisol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
growth hormone in ng/mL
Growth hormone levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
fasting insulin in uU/mL
Fasting insulin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
thyroid-stimulating hormone in uIU/mL
Thyroid-stimulating hormone levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
free thyroxine in pmol/L
Free thyroxine levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
free triiodothyronine in pmol/L
Free triiodothyronine levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
IL-1β in pg/mL
IL-1β levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
IL-6 in pg/mL
IL-6 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
IL-10 in pg/mL
IL-10 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
leptin in pg/mL
Leptin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
adiponectin in µg/mL
Adiponectin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
Hardness of liver in kPa
Hardness of liver is measured by Liver Ultrasound Elastography at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
Controlled Attenuation Parameter in dB/m
Controlled Attenuation Parameter is measured by Liver Ultrasound Elastography at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
Alpha diversity (Shannon index, Chao1)
Alpha diversity is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
Beta diversity (Bray-Curtis dissimilarity)
Beta diversity is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
Relative abundance of specific taxa (e.g., Firmicutes/Bacteroidetes ratio)
Relative abundance of specific taxa is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
Predicted functional pathways (via metagenomic analysis)
Predicted functional pathways are analyzed via metagenomic analysis after 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment.
Time frame: From enrollment to the end of treatment at 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.