NCT05108142

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

October 13, 2021

Last Update Submit

November 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    3 hours

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

    3 hours

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

    3 hours

Study Arms (2)

Control meal

EXPERIMENTAL

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

Other: Dietary intervention

Resistant starch meal

EXPERIMENTAL

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

Other: Dietary intervention

Interventions

fresh, hot pasta and re-heated pasta

Control mealResistant starch meal

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maha Alhussain

Riyadh, 11454, Saudi Arabia

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2021

First Posted

November 4, 2021

Study Start

November 1, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations