Post-prandial Glycemic Response to Fiber in Healthy Adults

NCT03252704 | Completed

• 1 other identifier: 16AFHI
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glucose, High Blood; Glucose, Low Blood; Meals

Keywords

postprandial glucose insulin

Outcome Measures

Primary Outcomes (1)

• Blood glucose response

  IV and capillary

  0-4 hours after consumption

Secondary Outcomes (2)

• Blood insulin response

  0-4 hours after consumption

• Breath hydrogen response

  0-24 hours after consumption

Study Arms (2)

High fiber - low fiber

EXPERIMENTAL

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

Other: resistant starch (high fiber muffin top); Other: control (low fiber muffin top)

low fiber - high fiber

EXPERIMENTAL

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

Other: resistant starch (high fiber muffin top); Other: control (low fiber muffin top)

Interventions

resistant starch (high fiber muffin top) OTHER

Muffin top contained 11 g of fiber per portion

High fiber - low fiber; low fiber - high fiber

control (low fiber muffin top) OTHER

Muffin top contained 1 g of fiber per portion

High fiber - low fiber; low fiber - high fiber

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ingredion Incorporated: lead
• KGK Science Inc.: collaborator

Related Publications (1)

• Stewart ML, Zimmer JP. Postprandial glucose and insulin response to a high-fiber muffin top containing resistant starch type 4 in healthy adults: a double-blind, randomized, controlled trial. Nutrition. 2018 Sep;53:59-63. doi: 10.1016/j.nut.2018.01.002. Epub 2018 Feb 13.

  PMID: 29655779 DERIVED

MeSH Terms

Interventions

Resistant Starch

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tetyana Pelipyagina, MD

  KGK Synergize

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: March 31, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: August 21, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share