Post-prandial Glycemic Response to Fiber in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized, double-blind, comparator controlled trial evaluated the blood glucose and insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Fiber on Glycemic Index

NCT02615327

Healthy

COMPLETED NA

Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus

NCT02204384

Dietary Modification Diabetes Mellitus Type 2 Insulin Tolerance +1 more

COMPLETED NA

A Study to Investigate the Effect of SFF on Glucose and Insulin Responses

NCT05587426

Postprandial Glycemic Response

COMPLETED NA

Fiber Effects on Glycemic Index

NCT02831738

Healthy

COMPLETED NA

Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults

NCT00687960

Hyperglycemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The fiber administered in this trial is a resistant starch type 4 derived from high-amylose maize starch. This product is high in dietary fiber (70% total dietary fiber (TDF), AOAC 2009.01 method) and can be used in a variety of bakery applications. The objective of this study was to evaluate the post-prandial blood glucose and insulin responses of healthy adults (n=28) after consuming a muffin top made with resistant starch or control muffin top, in a randomized, double-blind, crossover study. The muffin tops were matched for total weight, total carbohydrate, sugars, protein, and fat. During each 24-hour study period, subjects consumed a standard evening meal, fasted for 12 hours, and arrived at the study clinic the following morning. Serum glucose, serum insulin, and capillary glucose were measured after muffin top consumption. The subjects completed a seven day washout between treatments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glucose, High Blood Glucose, Low Blood Meals

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study products were concealed in opaque foil envelopes. The treatments were identified by alphanumeric code. The subjects and investigators did not know the identity of the treatments.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High fiber - low fiber

Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)

Group Type EXPERIMENTAL

resistant starch (high fiber muffin top)

Intervention Type OTHER

Muffin top contained 11 g of fiber per portion

control (low fiber muffin top)

Intervention Type OTHER

Muffin top contained 1 g of fiber per portion

low fiber - high fiber

Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)

Group Type EXPERIMENTAL

resistant starch (high fiber muffin top)

Intervention Type OTHER

Muffin top contained 11 g of fiber per portion

control (low fiber muffin top)

Intervention Type OTHER

Muffin top contained 1 g of fiber per portion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

resistant starch (high fiber muffin top)

Muffin top contained 11 g of fiber per portion

Intervention Type OTHER

control (low fiber muffin top)

Muffin top contained 1 g of fiber per portion

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age or older,
* BMI 18.0-29.9 kg/m2,
* fasting glucose ≤ 6.0 mmol/L;
* if female, not of childbearing potential (e.g. taking oral contraceptives, past hysterectomy)

Exclusion Criteria

* diagnosed metabolic or chronic diseases (e.g. type-2 diabetes);
* cancer diagnosis or treatment within 5 years;
* gastrointestinal problems;
* bowel cleansing during prior week;
* current medications to control blood glucose;
* current medications to control blood cholesterol ;
* current medications to control blood pressure;
* smoker;
* use of medical marijuana;
* alcohol or drug abuse treatment in past 12 months;
* allergy or sensitivity to study products;
* blood donation in prior 2 months;
* if female, currently pregnant, currently breastfeeding, or planning to become pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes