Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.

NCT02538653 | Completed

• 1 other identifier: KBE042
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content.

Conditions

Metabolic Disorder; Carbohydrate, Absorption, Intestine

Keywords

glycemic & insulin response, SDS, cereal product, Nutrition

Outcome Measures

Primary Outcomes (1)

• Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products

  2 hours after food consumption

Secondary Outcomes (2)

• Postprandial changes in glycaemia over 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC[180-240]) following the intake of the test products will be analysed.

  4 hours after food consumption

• Postprandial changes in insulinemia over 2 hours (iAUC [0-120]), over 3 hours (iAUC [0-180]), 4 hours (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC [180-240]) following the intake of the test products will be analysed.

  4 hours after food consumption

Other Outcomes (2)

• The plasma glucose peak value and the time for this latter will also be calculated.

  4 hours after food consumption

• The plasma insulin peak value and the time for this latter will also be calculated.

  4 hours after food consumption

Study Arms (2)

Sandwich biscuits high in SDS

EXPERIMENTAL

50 g of sandwich product with high level of SDS together with a glass of 250 mL of Evian water.

Other: Sandwich biscuit high in SDS

Co-extruded cereals low in SDS

ACTIVE COMPARATOR

48.3 g of co-extruded cereals low in SDS together with a glass of 250 mL of Evian water.

Other: Co-extruded cereal low in SDS

Interventions

Sandwich biscuit high in SDS OTHER

Consumption of the high SDS product (50g) alone with a glass of water

Sandwich biscuits high in SDS

Co-extruded cereal low in SDS OTHER

Consumption of the low SDS product (48.3 g) alone with a glass of water

Co-extruded cereals low in SDS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18-45 years.
• Non-smoker.
• BMI values between 19-30 kg/m2 (bounds included). Around half of the subjects will be normal weight and the other half overweight.
• Ethnicity. Subjects should have the closest characteristics compared to the American population. Not less than 75% but not more than 90% of the subjects should be Caucasian. Not more than 10% of the subjects will be of Asian or Asian Indian descent. The remaining subjects will be from other ethnic groups except from Australian Aborigines.
• Healthy subjects with:
• Normal glucose tolerance (fasting blood glucose \< 6.0 mmol/L during the first test session and results of oral glucose tolerance test conducted within the last 30 days within recommendations (fasting blood glucose \< 6.0 mmol/L, 120 minute glucose \< 8.9 mmol/L))
• Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol);
• Normal systolic blood pressure (100-150 mmHg);
• Normal diastolic blood pressure (60-90 mmHg);
• Normal resting heart rate (50-90 beats per minutes after 3 minutes rest).
• Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
• Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week)
• Able to fast for at least 10 hours the night before each test session
• Able to refrain from eating legumes and drinking alcohol the day before each test session.
• Subject covered by social security or covered by a similar system

You may not qualify if:

• Following a restrictive diet.
• Family history of Diabetes Mellitus or obesity
• Suffering from any clinical, physical or mental illness.
• Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
• Subject from the Australian Aboriginal ethnicity.
• Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
• Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
• Subject having taken part in another clinical trial within the last week.
• Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Sponsors & Collaborators

• Mondelēz International, Inc.: lead
• University of Sydney: collaborator

Study Sites (1)

University of Sydney

Sydney, New South Wales, 2006, Australia

Location

MeSH Terms

Conditions

Metabolic Diseases; Shwachman-Diamond Syndrome

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases; Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Lipid Metabolism, Inborn Errors; Lipid Metabolism Disorders; Lipomatosis

Study Officials

• Jennie Brand Miller

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

AU (1)