NCT03899974

Brief Summary

The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. So far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. This randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

March 29, 2019

Last Update Submit

December 3, 2019

Conditions

Postprandial Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • 2-hours blood glucose response

    incremental area under the curve

    over 2 hours after the test meal

Secondary Outcomes (5)

  • 2-hours blood insulin response

    over 2 hours after the test meal

  • 4-hours blood glucose response

    over 4 hours after the test meal

  • 4-hours blood insulin response

    over 4 hours after the test meal

  • intestinal fermentation

    over 4 hours after the test meal

  • glucose response

    over 2 hours after the standard meal

Study Arms (3)

70% amylose bread

EXPERIMENTAL

Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour)

Other: Test meal

85% amylose bread

EXPERIMENTAL

Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour)

Other: Test meal

Control bread

ACTIVE COMPARATOR

Mixed meal with 80g of available carbohydrates coming mainly from conventional bread

Other: Test meal

Interventions

Test mealOTHER

Participants received in random order the three test meal (700Kcal, 80g available carbohydrates) containing breads prepared with amylose-rich wheat flours (70% or 85%) or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations. After 4 hours, all participants consumed a standard lunch (700 kcal, 100 g available carbohydrates) identical on all the three experimental days to evaluate the "second meal effect" from breakfast to lunch.

70% amylose bread85% amylose breadControl bread

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight/obese
  • years

You may not qualify if:

  • age \<18 and \>70 years;
  • fasting triglycerides ≥400 mg/dl;
  • fasting cholesterol \>270 mg/dl;
  • cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study
  • established diabetes mellitus or any chronic disease
  • renal and liver failure (creatinine \>1.7 mg/dl and transaminases \>2 times than normal values, respectively)
  • anaemia (Hb \<12 g /dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University

Napoli, Naples, 80131, Italy

Location

Related Publications (1)

  • Costabile G, Vetrani C, Calabrese I, Vitale M, Cipriano P, Salamone D, Testa R, Paparo L, Russo R, Rivellese AA, Giacco R, Riccardi G. High Amylose Wheat Bread at Breakfast Increases Plasma Propionate Concentrations and Reduces the Postprandial Insulin Response to the Following Meal in Overweight Adults. J Nutr. 2023 Jan;153(1):131-137. doi: 10.1016/j.tjnut.2022.10.007. Epub 2022 Dec 20.

    PMID: 36913446DERIVED

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

March 1, 2018

Primary Completion

December 15, 2018

Study Completion

July 31, 2019

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)