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Metabolic Effect of New Foods Through Gut-brain Axis (CHECKMATE)

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ClinicalTrials.gov Identifier: NCT01851304
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Paola Vitaglione, Federico II University

Brief Summary:
A diet high in easily obtained energy-dense foods leads to the problems of overweight and obesity common in the developed world. Foods enriched with fiber or bitter compounds may increase satiety and decrease energy intake. This intervention will measure the effectiveness of coffee melanoidins, bread melanoidins, beta-glucans, and a Gentiana lutea L. extract in both a free or encapsulated form to decrease energy intake and modify the physiological markers of satiety in the short term. In particular bread (fiber) and a pudding (Gentiana lutea L. extract) will be used as tasty food matrices in the study.

Condition or disease Intervention/treatment Phase
Obesity Overweight Dietary Supplement: Satiety of breads Dietary Supplement: Satiety of puddings Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Checking Melanoidins and Bitter Compound Satiating Efficiency Through Evaluation of Human Gut-brain Response to Novel-food Ingestion
Study Start Date : September 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Placebo Comparator: Control Bread
A 100 g portion of Control Bread with no extra fiber added. The control bread will be consumed in the intervention Satiety of breads
Dietary Supplement: Satiety of breads
One separate breakfast session to consume each bread along with 125 mL skim milk. The session will start after an overnight fast followed by 5 separate blood draws over a 3 hour period before a provided lunch.

Experimental: Bread Crust Bread
A 100 g portion of Bread Crust Bread with 3 g bread crust per 100 g portion of control bread. The bread crust bread will be consumed in the intervention Satiety of breads.
Dietary Supplement: Satiety of breads
One separate breakfast session to consume each bread along with 125 mL skim milk. The session will start after an overnight fast followed by 5 separate blood draws over a 3 hour period before a provided lunch.

Experimental: Coffee Melanoidins Bread
A 100 g portion of Coffee Melanoidins Bread with 3 g of isolated coffee melanoidins per 100 g portion of control bread. The coffee melanoidins bread will be consumed in the intervention Satiety of breads.
Dietary Supplement: Satiety of breads
One separate breakfast session to consume each bread along with 125 mL skim milk. The session will start after an overnight fast followed by 5 separate blood draws over a 3 hour period before a provided lunch.

Experimental: beta-Glucans Bread
A 100 g portion of beta-Glucans Bread with 3 g of barley beta-glucans per 100 g portion of control bread. The beta-glucans bread will be consumed in the intervention Satiety of breads.
Dietary Supplement: Satiety of breads
One separate breakfast session to consume each bread along with 125 mL skim milk. The session will start after an overnight fast followed by 5 separate blood draws over a 3 hour period before a provided lunch.

Placebo Comparator: Control Pudding
A 150 g portion of Control Pudding without the addition of any extracts. The control pudding will be consumed in the intervention Satiety of puddings.
Dietary Supplement: Satiety of puddings
One separate breakfast session will be used to evaluate satiating efficacy of puddings after an overnight fast. After pudding consumption, five separate blood draws will be taken over a 3 hour period before a provided lunch.

Experimental: Gentian extract pudding
A 150 g portion of Gentian Pudding with the addition of 1 g Gentian extract per 100 g pudding. The Gentian extract pudding will be consumed in the intervention Satiety of puddings.
Dietary Supplement: Satiety of puddings
One separate breakfast session will be used to evaluate satiating efficacy of puddings after an overnight fast. After pudding consumption, five separate blood draws will be taken over a 3 hour period before a provided lunch.

Experimental: Encapsulated Gentian Extract Pudding
A 150 g portion of Microencapsulated Gentian extract pudding with the addition of 1 g of a microencapsulated Gentian extract per 100 g pudding. The Microencapsulated Gentian extract pudding will be consumed in the intervention Satiety of puddings.
Dietary Supplement: Satiety of puddings
One separate breakfast session will be used to evaluate satiating efficacy of puddings after an overnight fast. After pudding consumption, five separate blood draws will be taken over a 3 hour period before a provided lunch.




Primary Outcome Measures :
  1. Variation in the feelings of appetite [ Time Frame: 0, 0.5, 1, 2, and 3 hours ]
    Measure of the satiating effect for each bread and pudding with Visual Analog Scale (Area Under the Curve) over time for hunger, fullness and satiety.


Secondary Outcome Measures :
  1. Variation in neuropeptide markers [ Time Frame: 0, 0.5, 1, 2, 3 hours ]
    Measure serum beta-endorphin, neurotensin, orexin A, substance P, oxytocin, melatonin, alpha-melanocyte-stimulating hormone (pg/mL) and area under the curve (AUC) over time.

  2. Variation in stress markers [ Time Frame: 0, 0.5, 1, 2, 3 hours ]
    Measure serum cortisol (pg/mL) and area under the curve (AUC) over time.

  3. Variation in serum endocannabinoids [ Time Frame: 0, 0.5, 1, 2, 3 hours ]
    Measure serum anandamide, oleoylethanolamide, palmitoylethanolamide, linoleoyl ethanolamide (pg/mL) and area under the curve (AUC) over time.

  4. Variation in salivary enzyme activity [ Time Frame: 0, 0.5, 1, 2, 3 hours ]
    Measure salivary lipase (U/L) and salivary alpha-amylase (U/mL) activity.

  5. Variation in salivary endocannabinoids [ Time Frame: 0, 0.5, 1, 2, 3 hours ]
    Measure salivary anandamide, oleoylethanolamide, palmitoylethanolamide, linoleoyl ethanolamide (pg/mL)

  6. Variation in gastrointestinal markers [ Time Frame: 0, 0.5, 1, 2, 3 hours ]
    Measure serum ghrelin, peptide YY, glucagon-like peptide 1 (GLP-1), pancreatic polypeptide (PP), amylin, gastric inhibitory polypeptide (GIP), leptin, insulin (pg/mL)and area under the curve (AUC) over time.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal body weight: Body Mass Index between 20 - 30
  • Healthy by medical assessment
  • Signed a written informed consent form
  • Habitually consumes breakfast

Exclusion Criteria:

  • Pregnant or breast feeding
  • Diagnosed with intestinal or metabolic diseases/disorders, such as diabetes, renal, hepatic or pancreatic disorders, or ulcers
  • Has hypertension or high cholesterol
  • Food allergies and food intolerances including celiac disease and lactose intolerance
  • Previous abdominal or gastrointestinal surgery
  • Regular consumption of medication or drugs (including cannabis)
  • Antibiotic or prebiotic therapy within the previous 2 months of the study
  • Unwillingness to consume experimental foods
  • Concurrent participation or previous participation in another clinical trial during the past year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851304


Locations
Italy
Department of Agriculture and Food Science
Portici, Italy, 80055
Sponsors and Collaborators
Federico II University
Investigators
Study Director: Paola Vitaglione, Dr University of Naples

Responsible Party: Paola Vitaglione, Dr, Federico II University
ClinicalTrials.gov Identifier: NCT01851304     History of Changes
Other Study ID Numbers: CKMPON-013
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

Keywords provided by Paola Vitaglione, Federico II University:
beta-Glucans
Bitter
Bread
Coffee
Gentiana lutea
Melanoidins
Microencapsulation

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms