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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05108142
Other study ID # 19/01008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date March 15, 2020

Study information

Verified date November 2021
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date March 15, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary intervention
fresh, hot pasta and re-heated pasta

Locations

Country Name City State
Saudi Arabia Maha Alhussain Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in fasting and postprandial blood glucose concentrations (n=8) 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). 3 hours
Secondary Changes in of fasting and postprandial serum insulin concentrations (n=8) 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) 3 hours
Secondary Changes in subjective appetite ratings (Visual Analogue Scale) (n=8) 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 hours
Secondary Changes in fasting and postprandial plasma ghrelin concentrations (n=8) Fasting and postprandial ghrelin assessed using a commercial kit during laboratory visits (before and 3 hours following the meal consumption in the two visits) 3 hours
See also
  Status Clinical Trial Phase
Completed NCT03689738 - Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety N/A
Completed NCT05988580 - Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch. N/A