N/A N=96 Randomized Double-blind

The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

Impaired Fasting Glucose

Bottom Line

View on ClinicalTrials.gov: NCT02119325 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2015

Primary outcome: Primary: Cmax for Glucose in IFG Status Participants — 42.76; 47.40 mg/dL — p=0.0487

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 25% fibre (Dietary_supplement); 0% fibre (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax for Glucose in IFG Status Participants	42.76; 47.40	0.0487 sig
PRIMARY Cmax for Triglyceride in IFG Status Participants	121.07; 127.85	0.6116
SECONDARY Cmax for Glucose in Overweight Healthy Participants	38.98; 43.64	—
SECONDARY AUC for Glucose in Overweight Healthy Participants	27163.93; 27329.59	—
SECONDARY Tmax for Glucose in Overweight Healthy Participants	25.74; 25.78	—
SECONDARY Cmax for Triglyceride in Overweight Healthy Participants	126.20; 119.84	—
SECONDARY AUC for Triglycerides in Overweight Healthy Participants	59829.76; 60488.97	—
SECONDARY Tmax for Triglycerides in Overweight Healthy Participants	220.32; 218.75	—
SECONDARY Cmax for RLP Cholesterol in IFG Status Participants	0.82; 1.30	—
SECONDARY AUC for RLP Cholesterol in IFG Status Participants	1765.27; 1759.01	—
SECONDARY Tmax for RLP Cholesterol in IFG Status Participants	124.23; 125.00	—
SECONDARY Cmax for RLP Cholesterol in Overweight Healthy Participants	0.97; 1.33	—
SECONDARY AUC for RLP Cholesterol in Overweight Healthy Participants	1856.49; 1845.29	—
SECONDARY Tmax for RLP Cholesterol in Overweight Healthy Participants	116.84; 130.26	—
SECONDARY Cmax for Insulin in IFG Status Participants	190.90; 214.90	—
SECONDARY AUC for Insulin in IFG Status Participants	24920.06; 27066.11	—
SECONDARY Tmax for Insulin in IFG Status Participants	38.46; 39.23	—
SECONDARY Cmax for Insulin in Overweight Healthy Participants	188.84; 213.42	—
SECONDARY AUC for Insulin in Overweight Healthy Participants	21963.63; 25089.69	—
SECONDARY Tmax for Insulin in Overweight Healthy Participants	35.58; 36.41	—

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.

Eligibility Criteria

Inclusion Criteria

Healthy overweight male and female participants
Age 18-75 years
BMI ≥25 125 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02119325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.