Metabolic Effect of New Foods Through Gut-brain Axis

NCT01851304 | Completed DMC

• 1 other identifier: CKMPON-013
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Keywords

beta-Glucans; Bitter; Bread; Coffee; Gentiana lutea; Melanoidins; Microencapsulation

Outcome Measures

Primary Outcomes (1)

• Variation in the feelings of appetite

  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.

  0, 0.5, 1, 2, and 3 hours

Secondary Outcomes (6)

• Variation in neuropeptide markers

  0, 0.5, 1, 2, 3 hours

• Variation in stress markers

  0, 0.5, 1, 2, 3 hours

• Variation in serum endocannabinoids

  0, 0.5, 1, 2, 3 hours

• Variation in salivary enzyme activity

  0, 0.5, 1, 2, 3 hours

• Variation in salivary endocannabinoids

  0, 0.5, 1, 2, 3 hours

Study Arms (7)

Control Bread

PLACEBO COMPARATOR

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

Bread Crust Bread

EXPERIMENTAL

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

Coffee Melanoidins Bread

EXPERIMENTAL

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

beta-Glucans Bread

EXPERIMENTAL

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

Control Pudding

PLACEBO COMPARATOR

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

Gentian extract pudding

EXPERIMENTAL

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

Encapsulated Gentian Extract Pudding

EXPERIMENTAL

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

Interventions

Satiety of breads DIETARY_SUPPLEMENT

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.

Bread Crust Bread; Coffee Melanoidins Bread; Control Bread; beta-Glucans Bread

Satiety of puddings DIETARY_SUPPLEMENT

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.

Control Pudding; Encapsulated Gentian Extract Pudding; Gentian extract pudding

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Agriculture and Food Science

Portici, 80055, Italy

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paola Vitaglione, Dr

  University of Naples

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

IT (1)