Impaired Fasting Glucose
Conditions
Keywords
fibre, overweight, impaired fasting glucose
Brief summary
The primary aim of this study is to evaluate the effect of a fibre rich health food drink on the post prandial glucose and triglyceride peak in healthy overweight adults with impaired fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two period cross over study.
Interventions
DIETARY_SUPPLEMENT0% fibre
Placebo is an energy matched powdered beverage
DIETARY_SUPPLEMENT25% fibre
Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy overweight male and female participants * Age 18-75 years * BMI ≥25\<35 Kg/m2
Exclusion criteria
* Pregnancy/breast-feeding * Allergy/Intolerance * Anaemic participants: Hb \<10g/dL * Diabetic participants: fasting blood glucose \>125 mg/dL * Serum Aspartate Transaminase, Alkaline Phosphatase and Serum albumin level 3 times the upper limit of normal range * Participants on other medications (lipid lowering drugs, oral hypoglycemics)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax for Glucose in IFG Status Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG) |
| Cmax for Triglyceride in IFG Status Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax for Glucose in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults |
| Cmax for Triglyceride in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults |
| AUC for Triglycerides in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults |
| Tmax for Triglycerides in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults |
| Cmax for RLP Cholesterol in IFG Status Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG |
| AUC for RLP Cholesterol in IFG Status Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG |
| Tmax for RLP Cholesterol in IFG Status Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG |
| Cmax for RLP Cholesterol in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults |
| Cmax for Glucose in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults |
| Tmax for RLP Cholesterol in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults |
| Cmax for Insulin in IFG Status Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG |
| AUC for Insulin in IFG Status Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG |
| Tmax for Insulin in IFG Status Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG |
| Cmax for Insulin in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults |
| AUC for Insulin in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults |
| Tmax for Insulin in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults |
| AUC for RLP Cholesterol in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults |
| AUC for Glucose in Overweight Healthy Participants | Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes | To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults |
Countries
India
Participant flow
Recruitment details
Participants were mainly recruited from the study site database.
Pre-assignment details
Of the 210 participants screened, 114 participants were not randomised. The reasons for the same were: not meeting study criteria (n=42), lost to follow-up (n=5), and other reasons (n=67).
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants | 96 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period 1 | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 33.9 Years STANDARD_DEVIATION 7.42 |
| Impaired fasting glucose (IFG) status IFG | 26 participants |
| Impaired fasting glucose (IFG) status No IFG | 70 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 1 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 |
Outcome results
Primary
Cmax for Glucose in IFG Status Participants
To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Cmax for Glucose in IFG Status Participants | 42.76 mg/dL | Standard Deviation 24.229 |
| Placebo | Cmax for Glucose in IFG Status Participants | 47.40 mg/dL | Standard Deviation 23.233 |
Comparison: H0: There was no difference in the post prandial glucose peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with glucose as dependent variable, treatment and period as fixed effects and subject as random effect.p-value: 0.048795% CI: [-9.26, -0.03]ANOVA
Primary
Cmax for Triglyceride in IFG Status Participants
To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Cmax for Triglyceride in IFG Status Participants | 121.07 mg/dL | Standard Deviation 46.484 |
| Placebo | Cmax for Triglyceride in IFG Status Participants | 127.85 mg/dL | Standard Deviation 72.565 |
Comparison: H0: There was no difference in the post prandial triglyceride peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with triglyceride as dependent variable, treatment and period as fixed effects and subject as random effect.p-value: 0.611695% CI: [-34.02, 20.44]ANOVA
Secondary
AUC for Glucose in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | AUC for Glucose in Overweight Healthy Participants | 27163.93 mg*min/dL | Standard Deviation 2804.549 |
| Placebo | AUC for Glucose in Overweight Healthy Participants | 27329.59 mg*min/dL | Standard Deviation 3040.29 |
Secondary
AUC for Insulin in IFG Status Participants
To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | AUC for Insulin in IFG Status Participants | 24920.06 µIU*min/mL | Standard Deviation 10299.888 |
| Placebo | AUC for Insulin in IFG Status Participants | 27066.11 µIU*min/mL | Standard Deviation 10666.718 |
Secondary
AUC for Insulin in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | AUC for Insulin in Overweight Healthy Participants | 21963.63 µIU*min/mL | Standard Deviation 10310.8 |
| Placebo | AUC for Insulin in Overweight Healthy Participants | 25089.69 µIU*min/mL | Standard Deviation 13421.113 |
Secondary
AUC for RLP Cholesterol in IFG Status Participants
To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | AUC for RLP Cholesterol in IFG Status Participants | 1765.27 mmole*min/L | Standard Deviation 237.951 |
| Placebo | AUC for RLP Cholesterol in IFG Status Participants | 1759.01 mmole*min/L | Standard Deviation 230.544 |
Secondary
AUC for RLP Cholesterol in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | AUC for RLP Cholesterol in Overweight Healthy Participants | 1856.49 mmole*min/L | Standard Deviation 1049.372 |
| Placebo | AUC for RLP Cholesterol in Overweight Healthy Participants | 1845.29 mmole*min/L | Standard Deviation 904.018 |
Secondary
AUC for Triglycerides in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | AUC for Triglycerides in Overweight Healthy Participants | 59829.76 mg*min/dL | Standard Deviation 27022.972 |
| Placebo | AUC for Triglycerides in Overweight Healthy Participants | 60488.97 mg*min/dL | Standard Deviation 29642.057 |
Secondary
Cmax for Glucose in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Cmax for Glucose in Overweight Healthy Participants | 38.98 mg/dL | Standard Deviation 17.687 |
| Placebo | Cmax for Glucose in Overweight Healthy Participants | 43.64 mg/dL | Standard Deviation 19.22 |
Secondary
Cmax for Insulin in IFG Status Participants
To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Cmax for Insulin in IFG Status Participants | 190.90 µIU/mL | Standard Deviation 75.471 |
| Placebo | Cmax for Insulin in IFG Status Participants | 214.90 µIU/mL | Standard Deviation 84.08 |
Secondary
Cmax for Insulin in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Cmax for Insulin in Overweight Healthy Participants | 188.84 µIU/mL | Standard Deviation 87.184 |
| Placebo | Cmax for Insulin in Overweight Healthy Participants | 213.42 µIU/mL | Standard Deviation 100.641 |
Secondary
Cmax for RLP Cholesterol in IFG Status Participants
To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Cmax for RLP Cholesterol in IFG Status Participants | 0.82 mmole/L | Standard Deviation 0.78 |
| Placebo | Cmax for RLP Cholesterol in IFG Status Participants | 1.30 mmole/L | Standard Deviation 1.265 |
Secondary
Cmax for RLP Cholesterol in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Cmax for RLP Cholesterol in Overweight Healthy Participants | 0.97 mmole/L | Standard Deviation 1.009 |
| Placebo | Cmax for RLP Cholesterol in Overweight Healthy Participants | 1.33 mmole/L | Standard Deviation 1.783 |
Secondary
Cmax for Triglyceride in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Cmax for Triglyceride in Overweight Healthy Participants | 126.20 mg/dL | Standard Deviation 51.959 |
| Placebo | Cmax for Triglyceride in Overweight Healthy Participants | 119.84 mg/dL | Standard Deviation 56.151 |
Secondary
Tmax for Glucose in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Tmax for Glucose in Overweight Healthy Participants | 25.74 minutes | Standard Deviation 15.71 |
| Placebo | Tmax for Glucose in Overweight Healthy Participants | 25.78 minutes | Standard Deviation 11.972 |
Secondary
Tmax for Insulin in IFG Status Participants
To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Tmax for Insulin in IFG Status Participants | 38.46 minutes | Standard Deviation 23.949 |
| Placebo | Tmax for Insulin in IFG Status Participants | 39.23 minutes | Standard Deviation 19.115 |
Secondary
Tmax for Insulin in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Tmax for Insulin in Overweight Healthy Participants | 35.58 minutes | Standard Deviation 24.176 |
| Placebo | Tmax for Insulin in Overweight Healthy Participants | 36.41 minutes | Standard Deviation 21.048 |
Secondary
Tmax for RLP Cholesterol in IFG Status Participants
To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Tmax for RLP Cholesterol in IFG Status Participants | 124.23 minutes | Standard Deviation 84.068 |
| Placebo | Tmax for RLP Cholesterol in IFG Status Participants | 125.00 minutes | Standard Deviation 77.006 |
Secondary
Tmax for RLP Cholesterol in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Tmax for RLP Cholesterol in Overweight Healthy Participants | 116.84 minutes | Standard Deviation 77.088 |
| Placebo | Tmax for RLP Cholesterol in Overweight Healthy Participants | 130.26 minutes | Standard Deviation 76.507 |
Secondary
Tmax for Triglycerides in Overweight Healthy Participants
To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults
Time frame: Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes
Population: The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Tmax for Triglycerides in Overweight Healthy Participants | 220.32 minutes | Standard Deviation 37.115 |
| Placebo | Tmax for Triglycerides in Overweight Healthy Participants | 218.75 minutes | Standard Deviation 30.444 |