Metabolic Effects of High-amylose Wheat-based Breads

NCT ID: NCT03899974

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-07-31

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.

Conditions

Postprandial Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

70% amylose bread

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

Group Type: EXPERIMENTAL

Test meal

Intervention Type: OTHER

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.

85% amylose bread

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

Group Type: EXPERIMENTAL

Test meal

Intervention Type: OTHER

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.

Control bread

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

Group Type: ACTIVE_COMPARATOR

Test meal

Intervention Type: OTHER

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.

Interventions

Test 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

rivellese angela

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federico II University

Napoli, Naples, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 36913446 (View on PubMed)

Other Identifiers

252/17

Identifier Type: -

Identifier Source: org_study_id