Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal

NCT04788069 | Completed DMC

• 1 other identifier: S64824
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

During this project the effect of different types of sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.

Conditions

Energy Intake; Appetite Regulation

Outcome Measures

Primary Outcomes (6)

• Appetite measurements

  Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  During test day 1 (up to 4 hours)

• Appetite measurements

  Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  During test day 2 (up to 4 hours)

• Appetite measurements

  Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  During test day 3 (up to 4 hours)

• Food intake at subsequent meal

  Weighted amounts of ad-libitum food offered minus the weighted leftovers

  During test day 1 (240 minutes after ingestion of breakfast)

• Food intake at subsequent meal

  Weighted amounts of ad-libitum food offered minus the weighted leftovers

  During test day 2 (240 minutes after ingestion of breakfast)

• Food intake at subsequent meal

  Weighted amounts of ad-libitum food offered minus the weighted leftovers

  During test day 3 (240 minutes after ingestion of breakfast)

Secondary Outcomes (25)

• Oral processing behaviour

  During test day 1 (up to 15 minutes)

• Oral processing behaviour

  During test day 2 (up to 15 minutes)

• Oral processing behaviour

  During test day 3 (up to 15 minutes)

• Blood lipids

  During test day 1

• Blood lipids

  During test day 2

Study Arms (3)

Wholemeal bread

ACTIVE COMPARATOR

Treatment with wholemeal bread

Dietary Supplement: Wholemeal bread

Sourdough bread

ACTIVE COMPARATOR

Treatment with sourdough bread

Dietary Supplement: Sourdough bread

Bread with sourdough

ACTIVE COMPARATOR

Treatment with bread with sourdough

Dietary Supplement: Bread with sourdough

Interventions

Wholemeal bread DIETARY_SUPPLEMENT

180g wholemeal bread/day + fixed portion at test day

Wholemeal bread

Sourdough bread DIETARY_SUPPLEMENT

180g sourdough bread/day + fixed portion at test day

Sourdough bread

Bread with sourdough DIETARY_SUPPLEMENT

180g bread with sourdough/day + fixed portion at test day

Bread with sourdough

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female and male participants
• age range 18 - 50
• BMI range 18.5 - 25.0 kg/m2 at screening visit
• Regular eating pattern (3 meals per day on at least 5 days per week)
• Willingness to consume bread (180 g) on a daily base
• Stable body weight for the last 6 months

You may not qualify if:

• Currently smoking (has smoked in the last 28 days) or willingness to smoke during the study period
• Pregnancy, lactation or wish to become pregnant during the study period
• Family history of diabetes
• Previous or current gastrointestinal or endocrine disorders
• Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
• Intake of prescription medication
• Coeliac disease or gluten sensitivity
• Use of pre- or probiotics within one month preceding the study
• Use of antibiotics within 3 months preceding the study
• Excessive concern about eating habits or body weight as evidenced from scores \< 18 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard \& Messick, 1985)

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

Bread

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kristin Verbeke, Prof.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 9, 2021
• Study Start: June 1, 2021
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)