NCT02702934

Brief Summary

Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
Last Updated

August 10, 2017

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

March 2, 2016

Last Update Submit

August 9, 2017

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Incremental area under the curve

    4 hours

Secondary Outcomes (3)

  • Blood insulin

    4 hours

  • Intestinal fermentation

    4 hours

  • Blood triglycerides

    4 hours

Study Arms (2)

High-amylose rusks

EXPERIMENTAL

Test meal with 100g of carbohydrates coming from high-amylose rusks

Other: Test meal

Control rusks

ACTIVE COMPARATOR

Test meal with 100g of carbohydrates coming from regular rusks used as control

Other: Test meal

Interventions

Test mealOTHER

Participants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour 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.

Also known as: Acute test meal
Control rusksHigh-amylose rusks

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight/obese;
  • years.

You may not qualify if:

  • age \<30 and \>60 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);
  • any chronic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Medicine and Surgery

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Angela Rivellese, Professor

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 9, 2016

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

February 1, 2016

Last Updated

August 10, 2017

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)