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ObesityCHECKMATENCT01851304

Metabolic Effect of New Foods Through Gut-brain Axis

A study testing Satiety of breads and Satiety of puddings in people with Obesity and Overweight, run by Federico II University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Satiety of breads and Satiety of puddings
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteItaly
Study dates
Sep 2014to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Department of Agriculture and Food Science

    Portici, 80055

Other trials in Italy

About this study

Official title: Checking Melanoidins and Bitter Compound Satiating Efficiency Through Evaluation of Human Gut-brain Response to Novel-food Ingestion

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.

Read the detailed description

Overweight and obesity are health problems of utmost importance to the world population. The continuous development and consumption of high-energy foods at a low cost is correlated with an increased risk of diabetes and insulin resistance in addition to weight gain. To maintain body weight, a balance between energy intake and energy expenditure must be obtained. Since weight gain is a common outcome with an energy-dense diet, the best approach to reduce caloric intake is through the consumption of fruits and vegetables. However, this approach is usually unsatisfactory in the long-term as the loss of tasty food and the low reward of healthy meals often undermines the nutritionally prudent diet. A possible alternative approach is to produce tasty foods with low caloric density and satiety-inducing compounds that can reduce caloric intake and increase the sensation of satiety.

The human body regulates energy intake through a complex and interconnected biological system involving gut-brain axis, the endocannabinoid system and the hypothalamic-pituitary-adrenal axis. Biomarkers in the hypothalamic-pituitary-adrenal axis regulate food intake and the physiological response to stress. In the absence of food, the brain senses hunger through the elevation of the gastrointestinal hormone ghrelin. Once food is ingested, ghrelin levels decrease while other biomarkers in the gut-brain axis are released to increase feelings of satiety through the delay of gastric emptying, decrease in appetite and the decrease in food intake. Recent studies in mice have linked the endocannabinoid system with the hypothalamic-pituitary-adrenal axis through physiological stress and energy homeostasis. Furthermore, the endocannabinoids anandamide and 2-arachidonoylglycerol are both elevated during hunger but decrease after feeding.

Natural foods with low energy density, such as fruits and vegetables, usually contain a high amount of dietary fiber. Dietary fiber is classified as either soluble fiber (beta-glucans) or insoluble fiber (wheat bran) but both soluble and insoluble fiber have been strongly linked to increased satiety sensation. Dietary fiber is important for a properly functioning gastrointestinal tract by providing a nutrient source for bacteria in the large intestine. When a 3% portion of barley beta-glucans were added to a fruit drink or to bread and consumed at breakfast, a reduction in energy intake of 30% over 24 hours was observed along with beneficial changes in post-prandial gastrointestinal hormones involved in the biological control of hunger and satiety. Intake of insoluble fiber improves insulin sensitivity and enriched barley fiber bread or wheat fiber bread improved ghrelin and peptide YY (PYY) hormone response compared to control bread. A recently characterized class of food compounds, melanoidins, have been found to exhibit similar properties to dietary fiber in the gastrointestinal tract. Melanoidins are formed by the Maillard reaction process through the reaction of proteins with reduced carbohydrates and sugars during the cooking of heat-treated foods. Melanoidins are large insoluble or partially insoluble complexes that are present in coffee, bread, cocoa, and beer. However, the main sources of melanoidins in the diet are from coffee and bread with a contribution of 0.5-2.0 g/day of coffee melanoidins and 1.8-15 g/day of bread melanoidins. Research has shown that coffee melanoidins are fermented in the gastrointestinal tract while bread melanoidins stimulate bifidobacteria in the large intestine.

Bitter compounds have also been recently implicated in increasing satiety and having a beneficial effect on gastrointestinal tract hormones. Recent research in animals indicates that several bitter compounds can reduce the rate of gastric emptying, induce the secretion of satiety-inducing hormones cholecystokinin and glucagon-like peptide 1 (GLP-1), and decrease food intake. However, the animal experiments required the bitter compounds to be delivered directly to the stomach for action. A few bitter tasting vegetables, including broccoli and chicory, show beneficial health effects. Some natural phytochemicals are polyphenols known to possess different biological mechanisms and to have a bitter taste. The plant species Gentiana lutea L. produces several biologically active bitter phytochemicals, including the iridoid (loganic acid) and the secoiridoids (swertiamarin, gentiopicroside, amarogentin, sweroside). Gentiana lutea L. is used most often for the production of herbal teas and liqueurs.

In this randomized, crossover trial, the hunger and satiety feelings will be measured while blood will be collected at specific time points during the seven arms. Since this intervention is to develop tasty foods that both increase satiety and decrease energy intake in the short term, the bitter compounds will also be encapsulated in a protective coating. Encapsulation is commonly used to protect pharmaceuticals during passage through the oral cavity or stomach to enable the active compounds to be properly absorbed in the body. The coating used in one arm will allow the Gentiana lutea L. extract to pass through the oral cavity, allowing the volunteers to not taste the bitter compounds, for target in the stomach and duodenum.

All volunteers will participate in the seven arms of the study. Three different fiber-enriched breads and a control bread will be consumed in addition to skim milk at breakfast in four interventions. In the other three interventions, participants will consume a control pudding, Gentiana lutea L. extract pudding and the encapsulated Gentiana lutea L. extract pudding. A one-week washout period will be included between two separate interventions. The hedonic feelings of satiety, hunger, and appetite will be measured with a questionnaire at time 0 (baseline) and at 0.5, 1, 2, and 3 hours after breakfast. After 3 hours, the volunteers will consume lunch until they are satiated and then keep a food diary to record their intake throughout the rest of the day. In addition, blood will be collected at each time point and the amount of the specific hormones, neuropeptides, and endocannabinoids will be measured as part of the secondary outcomes.

Conditions
Obesity, Overweight
Being tested
Satiety of breads, Satiety of puddings
Keywords
beta-Glucans, Bitter, Bread, Coffee, Gentiana lutea, Melanoidins, Microencapsulation
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Satiety of breadsDietary 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.

  • Satiety of puddingsDietary 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.

Study groups in NCT01851304
Study groupRoleWhat they receive
Control BreadPlacebo comparatorA 100 g portion of Control Bread with no extra fiber added. The control bread will be consumed in the intervention Satiety of breads
Receives: Dietary Supplement: Satiety of breads
Bread Crust BreadExperimentalA 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.
Receives: Dietary Supplement: Satiety of breads
Coffee Melanoidins BreadExperimentalA 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.
Receives: Dietary Supplement: Satiety of breads
beta-Glucans BreadExperimentalA 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.
Receives: Dietary Supplement: Satiety of breads
Control PuddingPlacebo comparatorA 150 g portion of Control Pudding without the addition of any extracts. The control pudding will be consumed in the intervention Satiety of puddings.
Receives: Dietary Supplement: Satiety of puddings
Gentian extract puddingExperimentalA 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.
Receives: Dietary Supplement: Satiety of puddings
Encapsulated Gentian Extract PuddingExperimentalA 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.
Receives: Dietary Supplement: Satiety of puddings

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0, 0.5, 1, 2, and 3 hours

Secondary outcomes (6)
  1. Variation in neuropeptide markers

    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.

    Measured: 0, 0.5, 1, 2, 3 hours

  2. Variation in stress markers

    Measure serum cortisol (pg/mL) and area under the curve (AUC) over time.

    Measured: 0, 0.5, 1, 2, 3 hours

  3. Variation in serum endocannabinoids

    Measure serum anandamide, oleoylethanolamide, palmitoylethanolamide, linoleoyl ethanolamide (pg/mL) and area under the curve (AUC) over time.

    Measured: 0, 0.5, 1, 2, 3 hours

  4. Variation in salivary enzyme activity

    Measure salivary lipase (U/L) and salivary alpha-amylase (U/mL) activity.

    Measured: 0, 0.5, 1, 2, 3 hours

  5. Variation in salivary endocannabinoids

    Measure salivary anandamide, oleoylethanolamide, palmitoylethanolamide, linoleoyl ethanolamide (pg/mL)

    Measured: 0, 0.5, 1, 2, 3 hours

  6. Variation in gastrointestinal markers

    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.

    Measured: 0, 0.5, 1, 2, 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2013 (estimated)
  2. Study startSep 2014
  3. Primary completionJul 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01851304
Sponsor's protocol ID
CKMPON-013
Acronym
CHECKMATE
Status last verified
Sep 2015
First submitted
8 May 2013
Last updated
2 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Satiety of breads and Satiety of puddings in people with Obesity and Overweight, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in the feelings of appetite (time frame: 0, 0.5, 1, 2, and 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.

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