Skip to content

Metabolic Effects of High-amylose Wheat-based Rusks.

Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02702934
Enrollment
10
Registered
2016-03-09
Start date
2015-05-31
Completion date
2016-02-29
Last updated
2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

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.

Interventions

OTHERTest meal

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.

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Overweight/obese; * 30-60 years.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Blood glucose4 hoursIncremental area under the curve

Secondary

MeasureTime frameDescription
Blood insulin4 hoursIncremental area under the curve
Intestinal fermentation4 hoursIncremental area under the curve
Blood triglycerides4 hoursIncremental area under the curve

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026