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Metabolic Effects of High-amylose Wheat-based Breads

Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03899974
Enrollment
20
Registered
2019-04-02
Start date
2018-03-01
Completion date
2019-07-31
Last updated
2019-12-04

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

Conditions

Postprandial Hyperglycemia

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.

Interventions

OTHERTest meal

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.

Sponsors

Federico II University
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Overweight/obese * 18-70 years

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
2-hours blood glucose responseover 2 hours after the test mealincremental area under the curve

Secondary

MeasureTime frameDescription
2-hours blood insulin responseover 2 hours after the test mealincremental area under the curve
4-hours blood glucose responseover 4 hours after the test mealincremental area under the curve
4-hours blood insulin responseover 4 hours after the test mealincremental area under the curve
intestinal fermentationover 4 hours after the test mealbreath test for the detection of hydrogen production
glucose responseover 2 hours after the standard mealSecond meal effect

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026