Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake

NCT06015867 | Completed

• 1 other identifier: S64824 - B3222020000339
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Appetite; Satiety; Energy Intake; Glucose Response; Insulin Response; Gastric Emptying

Outcome Measures

Primary Outcomes (4)

• Appetite measurements

  Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely). Measurements will be taken: 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), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely). Measurements will be taken: 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)

• 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)

Secondary Outcomes (16)

• Glucose response

  During test day 1 (up to 4 hours)

• Glucose response

  During test day 2 (up to 4 hours)

• Insulin response

  During test day 1 (up to 4 hours)

• Insulin response

  During test day 2 (up to 4 hours)

• Gastric emptying rate

  During test day 1 (up to 4 hours)

Study Arms (2)

Control Bread: Wholemeal Yeast Bread

ACTIVE COMPARATOR

Wholemeal bread, containing mainly of wholemeal flour, water and bakers' yeast will be used as the control test bread.

Dietary Supplement: Dietary Intervention with Wholemeal Bread with Yeast; Dietary Supplement: Dietary Intervention with Wholemeal Sourdough Bread

Wholemeal Sourdough Bread

ACTIVE COMPARATOR

Wholemeal sourdough bread, containing mainly of wholemeal flour, water and added sourdough co-culture (consisting of W.anom.+ C.crust strain).

Dietary Supplement: Dietary Intervention with Wholemeal Bread with Yeast; Dietary Supplement: Dietary Intervention with Wholemeal Sourdough Bread

Interventions

Dietary Intervention with Wholemeal Bread with Yeast DIETARY_SUPPLEMENT

Single administration of 150g wholemeal long-time processed bread with baker's yeast, with no lactic acid (control).

Control Bread: Wholemeal Yeast Bread; Wholemeal Sourdough Bread

Dietary Intervention with Wholemeal Sourdough Bread DIETARY_SUPPLEMENT

Single administration of 150g wholemeal long-time processed sourdough bread (with alternative lactic acid bacteria and yeast) high in lactic acid concentration.

Control Bread: Wholemeal Yeast Bread; Wholemeal Sourdough Bread

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)
• 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)
• 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 (2)

KU Leuven/UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Diet Therapy; Yeast, Dried

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kristin Verbeke, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 29, 2023
• Study Start: January 1, 2024
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)