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Completed

NCT Number: NCT03252704

Post-prandial Glycemic Response to Fiber in Healthy Adults

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resistant starch (high fiber muffin top)

Other

Muffin top contained 11 g of fiber per portion

control (low fiber muffin top)

Other

Muffin top contained 1 g of fiber per portion

Primary outcomes

  1. Blood glucose response

    Time frame: 0-4 hours after consumption

    IV and capillary

Secondary outcomes

  1. Blood insulin response

    Time frame: 0-4 hours after consumption

    IV

  2. Breath hydrogen response

    Time frame: 0-24 hours after consumption

    Expired air

Sponsors and collaborators

Lead sponsor

Ingredion Incorporated

Industry

Collaborators

  • KGK Science Inc.

Registry information

Official study title

Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2017
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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