Resistant Starch Type-3, Glucose Metabolism and Appetite

Sponsor
King Saud University (Other)
Overall Status
Completed
CT.gov ID
NCT05108142
Collaborator
(none)
8
1
2
4.4
1.8

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of Resistant Starch Type-3 on Glucose Metabolism and Appetite in Healthy Adult Males
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Mar 15, 2020
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Control meal

Participants were asked to visit the lab and consume the control meal (hot, freshly cooked pasta)

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

Experimental: Resistant starch meal

Participants were asked to visit the lab and consume the resistant starch meal (re-heated pasta)

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maha Alhussain Riyadh Saudi Arabia 11454

Sponsors and Collaborators

  • King Saud University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maha Alhussain, Principal Investigator, King Saud University
ClinicalTrials.gov Identifier:
NCT05108142
Other Study ID Numbers:
  • 19/01008
First Posted:
Nov 4, 2021
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 15, 2021