Healthy Clinical Trial
Official title:
A Randomized, Controlled, Crossover Study to Assess the Glucose and Insulin Excursions of a Test Fiber
The objective of this trial is to evaluate the postprandial glucose and insulin responses to replacing digestible carbohydrates with resistant starch type 4 (RS4) in a baked product in healthy men and women. A randomized, double-blinded cross-over study will be conducted comparing two foods (a reference food and a test food). The primary outcome variable will be the incremental area under the curve (iAUC) for capillary glucose from pre-product consumption (average of t = -15 and -5 min) to 120 min (iAUC0-120 min). This study will provide substantiation for a beneficial reduction in glycemic response followed by the consumption of the active product containing an efficacious dose of resistant starch type 4 (RS4).
The study is a randomized, controlled, double-blind, crossover trial that includes one
screening visit (Visit 1; day -7) and two test visits (Visits 2 and 3; days 0 and 7) which
are separated by a washout period of 4-7 days. At Visit 1 (day -7), subjects will provide
informed consent and undergo screening assessments including evaluations of medical history,
prior/current medication/supplement use, inclusion and exclusion criteria, height, body
weight, BMI, vital signs, and Vein Access Scale. A fasting capillary blood glucose will be
assessed for eligibility purposes and an in-clinic urine pregnancy test (all women) will also
be obtained. Subjects will then be dispensed a 24-h Diet Record with instructions to record
intake the day prior to Visit 2 (day 0). At Visit 2 (day 0), subjects will arrive at the
clinic fasted (10-14 h, water only, anchored to the t = -15 min blood draw), to undergo
clinic visit procedures. Adverse events (AE) will be assessed and subjects will be queried
about test day instructions compliance. Additionally, the 24-h Diet Record will be collected
and reviewed. Eligible subjects will be randomly assigned to a randomization sequence and
will undergo the glycemic and insulinemic response test with blood glucose concentrations
assessed via capillary measurement and insulin concentrations assessed via venous
measurement. Blood samples (capillary and venous) will be obtained at t = -15 and -5 ± 5 min.
Subjects will consume the study product in its entirety within 10 min at t = 0 min with 8 oz
of water. Capillary and venous blood samples will be obtained at t = 15, 30, 45, 60, 90, and
120 ± 5 min, where t = 0 min is the start of study product consumption, to assess glucose and
insulin concentrations. Subjects will be provided one-8 oz bottle of water to consume at t =
0 to 60 min and one-8 oz bottle of water to consume at t = 61 to 120 min. Water consumption
will be recorded and replicated at the subsequent test visits. AEs will be assessed and
subjects will be dispensed a blank/new 24-h Diet Record to record all food and beverage
consumed the day prior to Visit 3, day 7; as well as a copy of the completed 24-h Diet Record
(from day -1) with instructions to replicate the same food and beverage intake as closely as
possible the day prior to the next test visit (Visit 3, day 7). Test day instructions will
also be provided. At Visit 3 (day 7), subjects will return to the clinic for clinic visit
procedures. AEs will be assessed and subjects will be queried about test day instructions
compliance. The 24-h Diet Record will be collected and study staff will review the 24-h Diet
Record to compare food and beverage consumption to the day -1 Diet Record for consistency.
Subjects will then crossover to the next study product in their test sequence and repeat the
glycemic/insulinemic response test described above for Visit 2. At the conclusion of the
glycemic/insulinemic response test, AEs will be assessed.
An evaluable sample size of 19 is required to observe a statistically significant difference
between active and control products (α = 0.05 (2- tailed); power = 80%) assuming that the
glucose response of the Cargill active product is 61% of that of the control product and
standard deviation is 65% of the mean value (standard deviation estimation is based on a
recently completed proprietary study conducted by Biofortis on baked products containing
different amounts of fiber). To account for possible attrition, a total of 22 subjects will
be enrolled. Each subject will consume a single serving of the control or active product.
These consumption events will be separated by at least 4 days.
All statistical analyses will be conducted using Statistical Analysis Systems (SAS) for
Windows (version 9.4, Cary, NC) and/or R 3.3.1 (R Core Team 2016). The data will be analyzed
for the modified intent-to-treat population, which will include all subjects who complete the
test condition and the reference product. Assessment for outliers, as per the International
Organization for Standardization (ISO) standards, will also be conducted. All decisions
regarding subject population and data inclusion will be documented prior to database lock.
Descriptive statistics [number of subjects, mean, standard deviation, standard error of the
mean (SEM), median, interquartile limits, minimum and maximum or frequency counts] will be
presented for subject demographics and anthropometric measurements collected at
screening/baseline. Incremental area under the curve (iAUC) 0-120 min will be calculated as
outlined in ISO 26642:2010(E) for each subject. Descriptive statistics (i.e. number of
subjects, minimum and maximum, median, inter-quartile limits, mean, SEM, and standard
deviation) will be presented for all the continuous outcomes for each test group. All tests
of significance, unless otherwise stated, will be performed at alpha=0.05, two sided. A
repeated measures analysis of covariance (ANCOVA) will be used to assess differences between
test groups for the primary and secondary outcome variables with the exception of the
comparisons between groups for glucose and insulin concentrations at each time point. Initial
repeated measures ANCOVA models will contain terms for test group, test sequence, and test
period, with test group specified as a repeated effect and subject nested within sequence.
Models will be reduced using a backward selection method until only significant terms or test
group remains in the model. Appropriate least squares mean values and corresponding SEM will
be derived from the final model for each test group. Assumption of normality of residuals
will be investigated at the 5% level with the Shapiro-Wilk test (Shapiro 1965). If the
normality assumption is not satisfied, then an analysis based on ranks will be performed.
Average blood glucose response curve, as described in ISO 26642:2010(E), and time curve plots
of the observed glucose and insulin concentration per time point per test product will be
presented. Glucose concentrations will be provided in mg/dL and insulin concentrations will
be provided at μIU/mL.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |