N/A
N=16
Comparison of the Postprandial Glycemic and Insulinemic Response After a Fibersym Containing Cookie With a Control
Postprandial Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT04820322 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: 2-hour Postprandial Glucose Incremental Area Under the Curve (IAUC) — 124; 106 mmol*min/L — p=0.087
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fibersym (Other); Control cookie (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MGP Ingredients, Inc.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-hour Postprandial Glucose Incremental Area Under the Curve (IAUC) |
124; 106 | 0.087 |
| SECONDARY 2-hour Postprandial Insulin Incremental Area Under the Curve (IAUC) |
245; 189 | 0.020 sig |
| SECONDARY Abdominal Bloating |
8; 8 | 1.00 |
| SECONDARY Belching |
9; 10 | 0.70 |
| SECONDARY Nausea |
8; 9 | 0.71 |
| SECONDARY Diarrhea |
6; 7 | 0.71 |
| SECONDARY Flatulence |
11; 12 | 0.67 |
| SECONDARY Satiety Scores |
79; 70 | 0.11 |
Summary
Fibersym® is a RS4-type resistant modified wheat starch in which over 85% of the total starch is resistant starch as measured by AOAC method 991.43. It is meant to be consumed on a regular basis and doses up to 33g/day can be tolerated. The effect of a Fibersym-containing meal on postprandial glucose and insulin levels when compared to a control meal, where both meals contain the same amount of available carbohydrate, is not known. This study therefore investigated the acute effect of a Fibersym cookie and a control cookie matched for available carbohydrate after a 3-day habituation period.
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant females, 18-75 years of age, inclusive
- Body mass index (BMI) between 18.5 and 35 kg/m² inclusive at screening.
- Systolic blood pressure 3.5 kg within 4 weeks of the screening visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Exposure to any non-registered drug product within 30 d prior to screening.
- Pregnancy or breastfeeding
- Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional
Data sourced from ClinicalTrials.gov (NCT04820322). 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.