The objective of this study is to investigate the effect of a high protein, high fiber dietary supplement on weight and fat loss in healthy overweight adults. Half of participants will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the subjects will receive a placebo (that contains the same amount of calories as the supplement) twice a day for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
206
Dry powder to be mixed with 10 ounces of cold water
Dry powder to be mixed with 10 ounces of cold water
Great Lakes Clinical Trials (of MB Clinical Research and Consulting, LLC)
Chicago, Illinois, United States
KGK Synergize Inc.
London, Ontario, Canada
GI Labs, Inc.
Toronto, Ontario, Canada
Change in body weight (kg)
Body weight measured by clinic study staff at required visits
Time frame: Baseline and 12 weeks
Change in body fat percentage (%)
Body fat percentage as determined by dual x-ray absorptiometry (DXA)
Time frame: Baseline and 12 weeks
Change in total fat mass (kg)
Body fat mass as determined by DXA
Time frame: Baseline and 12 weeks
Change in total lean mass (kg)
Body lean mass as determined by DXA
Time frame: Baseline and 12 weeks
Change in percent abdominal fat (%)
Abdominal fat percentage as determined by DXA
Time frame: Baseline and 12 weeks
Change in percent android fat (%)
Android fat percentage as determined by DXA
Time frame: Baseline and 12 weeks
Change in percent gynoid fat (%)
Gynoid fat percentage as determined by DXA
Time frame: Baseline and 12 weeks
Change in percent trunk fat (%)
Trunk fat percentage as determined by DXA
Time frame: Baseline and 12 weeks
Change in percent leg fat (%)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Leg fat percentage as determined by DXA
Time frame: Baseline and 12 weeks
Change in body weight (kg)
Body weight measured by clinic study staff at required visits
Time frame: Baseline and 4 weeks
Change in body weight (kg)
Body weight measured by clinic study staff at required visits
Time frame: Baseline and 8 weeks
Change in Waist circumference (cm)
measured with a tape measure at the part of the trunk located midway between the lower costal margin and the iliac crest while the person is standing
Time frame: Baseline and 4 weeks
Change in Waist circumference (cm)
measured with a tape measure at the part of the trunk located midway between the lower costal margin and the iliac crest while the person is standing
Time frame: Baseline and 8 weeks
Change in Waist circumference (cm)
measured with a tape measure at the part of the trunk located midway between the lower costal margin and the iliac crest while the person is standing
Time frame: Baseline and 12 weeks
Change in Hip circumference (cm)
measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
Time frame: Baseline and 4 weeks
Change in Hip circumference (cm)
measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
Time frame: Baseline and 8 weeks
Change in Hip circumference (cm)
measured with a tape measure around the greater trochanteric prominence (the widest part of the hips)
Time frame: Baseline and 12 weeks
Change in Waist to hip ratio
Ratio of waist circumference to hip circumference
Time frame: Baseline and 4 weeks
Change in Waist to hip ratio
Ratio of waist circumference to hip circumference
Time frame: Baseline and 8 weeks
Change in Waist to hip ratio
Ratio of waist circumference to hip circumference
Time frame: Baseline and 12 weeks
Change in Blood leptin (ng/mL)
Fasting level of leptin in the blood
Time frame: Baseline and 12 weeks
Change in Blood adiponectin (mcg/mL)
Fasting level of adiponectin in the blood
Time frame: Baseline and 12 weeks
Change in Total cholesterol (mg/dL)
Fasting level of total cholesterol in blood
Time frame: Baseline and 4 weeks
Change in Total cholesterol (mg/dL)
Fasting level of total cholesterol in blood
Time frame: Baseline and 8 weeks
Change in Total cholesterol (mg/dL)
Fasting level of total cholesterol in blood
Time frame: Baseline and 12 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Fasting level of LDL cholesterol in blood
Time frame: Baseline and 4 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Fasting level of LDL cholesterol in blood
Time frame: Baseline and 8 weeks
Change in low-density lipoprotein (LDL) Cholesterol (mg/dL)
Fasting level of LDL cholesterol in blood
Time frame: Baseline and 12 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Fasting level of HDL cholesterol in blood
Time frame: Baseline and 4 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Fasting level of HDL cholesterol in blood
Time frame: Baseline and 8 weeks
Change in high-density lipoprotein (HDL) Cholesterol (mg/dL)
Fasting level of HDL cholesterol in blood
Time frame: Baseline and 12 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Fasting level of Ox-LDL cholesterol in blood
Time frame: Baseline and 4 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Fasting level of Ox-LDL cholesterol in blood
Time frame: Baseline and 8 weeks
Change in oxidized LDL (Ox-LDL) Cholesterol (U/L)
Fasting level of Ox-LDL cholesterol in blood
Time frame: Baseline and 12 weeks
Change in triglycerides (mg/dL)
Fasting level of triglycerides in blood
Time frame: Baseline and 4 weeks
Change in triglycerides (mg/dL)
Fasting level of triglycerides in blood
Time frame: Baseline and 8 weeks
Change in triglycerides (mg/dL)
Fasting level of triglycerides in blood
Time frame: Baseline and 12 weeks
Change in Insulin (IU)
Fasting level of insulin in blood
Time frame: Baseline and 4 weeks
Change in Insulin (IU)
Fasting level of insulin in blood
Time frame: Baseline and 8 weeks
Change in Insulin (IU)
Fasting level of insulin in blood
Time frame: Baseline and 12 weeks
Change in Glucose (mmol/L)
Fasting level of glucose in blood
Time frame: Baseline and 4 weeks
Change in Glucose (mmol/L)
Fasting level of glucose in blood
Time frame: Baseline and 8 weeks
Change in Glucose (mmol/L)
Fasting level of glucose in blood
Time frame: Baseline and 12 weeks
Change in blood glycated haemoglobin (HbA1c) (mmol/mol)
Fasting level of HbA1c in blood
Time frame: Baseline and 12 weeks
Change in gut microbiota composition
Genera of bacteria measured in stool samples
Time frame: Baseline and 12 weeks