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Completed

NCT Number: NCT05108142

Resistant Starch Type-3, Glucose Metabolism and Appetite

Resistant starch (RS) is considered to have many of the same health benefits as dietary fiber. The aim of this study was to examine the effects of RS3 on postprandial glycemic and insulinemic responses and appetite.

Healthy males (aged 18-35 years) participated in this study. Subjects were provided meals in the laboratory after overnight fasting on two separate occasions, at least 1 week apart. On each laboratory visit, subjects were given either a control meal (COM) or an RS3 meal (RSM). Both meals during the two visits consisted of vegetarian pasta and were matched for energy intake, composition, ingredients, and amount, but were prepared in different ways. The COM was hot, freshly cooked pasta, while the RSM was re-heated pasta that had been cooked the previous day and chilled overnight. Blood samples and subjective appetite ratings were collected at fasting and for a period of 3 h after meal consumption (i.e., 15-min intervals for glucose and 30-min intervals for insulin, ghrelin, and subjective appetite).

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maha Alhussain

Riyadh, 11454, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males
  • Aged between 18 and 40 years
  • Normal weight (BMI 18.5-24.9 kg/m2)
  • No history of serious disease or currently taking any medications
  • Not dieting or seeking to lose weight.

Exclusion criteria

  • Smokers
  • Allergy to gluten-containing products, lactose intolerance, or dairy allergy
  • Particular dislike to any of the foods provided during the study.

Treatment and study plan

Dietary Intervention

Other

fresh, hot pasta and re-heated pasta

Primary outcomes

  1. Changes in fasting and postprandial blood glucose concentrations (n=8)

    Time frame: 3 hours

    Fasting and postprandial blood glucose assessed with the use of a portable monitor (Accu-Chek) during laboratory visits (before and 3 hours following the meal consumption in the two visits).

Secondary outcomes

  1. Changes in of fasting and postprandial serum insulin concentrations (n=8)

    Time frame: 3 hours

    Fasting and postprandial serum insulin assessed using a commercial kit during laboratory visits (before and 3 hours following the meal consumption in the two visits)

  2. Changes in subjective appetite ratings (Visual Analogue Scale) (n=8)

    Time frame: 3 hours

    Subjective appetite ratings were assessed during laboratory visits (before and 3 hours following the meal consumption in the two visits) with the use of paper-based visual analog scales with words anchored at each end of a 100-mm horizontal line that expressed the most-positive rating and the most-negative rating for a question. The questions were in the form of "How (rating) do you feel?" (with ratings of hungry, satisfied, and full), "How much of a desire to eat?" and "How much do you think you can eat?"

  3. Changes in fasting and postprandial plasma ghrelin concentrations (n=8)

    Time frame: 3 hours

    Fasting and postprandial ghrelin assessed using a commercial kit during laboratory visits (before and 3 hours following the meal consumption in the two visits)

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Impact of Resistant Starch Type-3 on Glucose Metabolism and Appetite in Healthy Adult Males

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 4, 2021
Registry last updated
Nov 15, 2021

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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