Proof of Concept Study; The Effect of an Encapsulated Nutrient Mixture on Ileal Brake Activation

NCT02635659 | Completed DMC

• 1 other identifier: METC 143062
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Intraileal infusion of nutrients results in a reduction in food intake. A previous study by our group showed that both sucrose and casein infusion resulted in an increase in satiety and release of gastrointestinal peptides and a decrease in hunger and food intake. Encapsulating both nutrients, daily ingestion of this micro encapsulate and hereby releasing them in the distal small intestine could result in a chronic ileal brake activation. The obtained reduction in food intake and caloric intake could help overweight subjects to lose weight.

Conditions

Body Weight Decreased

Keywords

food intake, satiety, satiation, nutrients, ileal brake

Outcome Measures

Primary Outcomes (1)

• Ileal brake activation and weight loss.

  The difference in body weight before and after 6 weeks ileal brake activation by nutrient delivery to the distal small intestine (active; group 1) compared to nutrient mixture delivery to the stomach (placebo; group 2).

  43 days (measuring outcome at T=23 days and T=43 days)

Secondary Outcomes (2)

• Ileal brake and food intake.

  43 days (measuring outcome at T=23 days and T=43 days)

• Ileal brake and VAS scores.

  43 days (measuring outcome at T=23 days and T=43 days)

Other Outcomes (2)

• Ileal brake and plasma GLP-1 level

  43 days (measuring outcome at T=23 days and T=43 days)

• Ileal brake and plasma glucose level

  43 days (measuring outcome at T=23 days and T=43 days)

Study Arms (2)

Encapsulated nutrients

EXPERIMENTAL

The investigational product will be a shot of sterile water (80 ml) mixed with a total of 21.6 grams encapsulate consisting of 13 grams of sucrose (60% of the total) encapsulated whey protein (\<5% of total). On top of the encapsulated sucrose, 6.44 grams of casein (30% of total) encapsulated in whey protein (\<5% of total) will be mixed with the shot of water. The micro-beats of encapsulated sucrose and casein are 150 µm and the ratio active (sucrose and casein) : whey is 95:5%, this means that the shot of water contains 13 grams of encapsulated sucrose, 6.44 grams of encapsulated casein and 1.3 grams of whey protein required for the encapsulation.

Other: Encapsulated nutrients

Placebo

PLACEBO COMPARATOR

The placebo has the same nutrient composition (e.g. 13 grams of sucrose and 6.44 grams of casein) as the active and will be equicaloric, and will also be mixed with a shot of sterile water (80 ml). The main difference of the placebo is that this nutrient mixture will be immediately released in the stomach, instead of being delivered to the ileum (active). This immediate release of the nutrient mixture is possible by using a different micro-encapsulation technique.

Other: Placebo

Interventions

Encapsulated nutrients OTHER

Encapsulated nutrients

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Based on medical history and previous examination, no gastrointestinal complaints can be defined.
• Age between 18 and 65 years. A higher age comes with a higher chance of comorbidities. These could influence our study outcomes and therefore this age range was chosen. This study will include healthy adult subjects (male and female). Women must be taking contraceptives (only needed in women with childbearing potential)
• BMI between 25 -30 kg/m2
• Normal Dutch eating habits eating three meals a day including breakfast as assessed by a validated questionnaire
• Voluntary participation
• Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions

You may not qualify if:

• History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided and documented by the principal investigator.
• Use of any medication, except oral contraceptives, which may interfere with this study (major interference with the execution of the experiment or potential influence on the study outcomes). This has to be decided and documented by the principle investigator.
• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study, to be decided by the principle investigator, in the 90 days prior to the study.
• Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery) upon judgement of the principle investigator.
• Dieting (medically prescribed, diabetic and vegetarian)
• Pregnancy, lactation
• Excessive alcohol consumption (\>20 alcoholic consumptions per week)
• Intention to stop smoking
• Self-admitted HIV-positive state
• Above average score (\>2.26) on the restrained eating scale of the Dutch Eating Behaviour Questionnaire
• Reported unexplained weight loss or gain of \>4 kg in the month prior to screening

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (11)

• Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001 Nov;74(5):579-84. doi: 10.1093/ajcn/74.5.579.

  PMID: 11684524 BACKGROUND

• Batsis JA, Clark MM, Grothe K, Lopez-Jimenez F, Collazo-Clavell ML, Somers VK, Sarr MG. Self-efficacy after bariatric surgery for obesity. A population-based cohort study. Appetite. 2009 Jun;52(3):637-645. doi: 10.1016/j.appet.2009.02.017. Epub 2009 Mar 9.

  PMID: 19501761 BACKGROUND

• Johansson K, Neovius M, Hemmingsson E. Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2014 Jan;99(1):14-23. doi: 10.3945/ajcn.113.070052. Epub 2013 Oct 30.

  PMID: 24172297 BACKGROUND

• Maljaars PW, Peters HP, Mela DJ, Masclee AA. Ileal brake: a sensible food target for appetite control. A review. Physiol Behav. 2008 Oct 20;95(3):271-81. doi: 10.1016/j.physbeh.2008.07.018. Epub 2008 Jul 21.

  PMID: 18692080 BACKGROUND

• Maljaars PW, Peters HP, Kodde A, Geraedts M, Troost FJ, Haddeman E, Masclee AA. Length and site of the small intestine exposed to fat influences hunger and food intake. Br J Nutr. 2011 Nov;106(10):1609-15. doi: 10.1017/S0007114511002054. Epub 2011 Jun 7.

  PMID: 21736790 BACKGROUND

• Maljaars J, Romeyn EA, Haddeman E, Peters HP, Masclee AA. Effect of fat saturation on satiety, hormone release, and food intake. Am J Clin Nutr. 2009 Apr;89(4):1019-24. doi: 10.3945/ajcn.2008.27335. Epub 2009 Feb 18.

  PMID: 19225118 BACKGROUND

• van Avesaat M, Troost FJ, Ripken D, Hendriks HF, Masclee AA. Ileal brake activation: macronutrient-specific effects on eating behavior? Int J Obes (Lond). 2015 Feb;39(2):235-43. doi: 10.1038/ijo.2014.112. Epub 2014 Jun 24.

  PMID: 24957485 BACKGROUND

• Shin HS, Ingram JR, McGill AT, Poppitt SD. Lipids, CHOs, proteins: can all macronutrients put a 'brake' on eating? Physiol Behav. 2013 Aug 15;120:114-23. doi: 10.1016/j.physbeh.2013.07.008. Epub 2013 Aug 1.

  PMID: 23911804 BACKGROUND

• Schellekens RC, Stellaard F, Olsder GG, Woerdenbag HJ, Frijlink HW, Kosterink JG. Oral ileocolonic drug delivery by the colopulse-system: a bioavailability study in healthy volunteers. J Control Release. 2010 Sep 15;146(3):334-40. doi: 10.1016/j.jconrel.2010.05.028. Epub 2010 May 31.

  PMID: 20621586 BACKGROUND

• Varum FJ, Hatton GB, Freire AC, Basit AW. A novel coating concept for ileo-colonic drug targeting: proof of concept in humans using scintigraphy. Eur J Pharm Biopharm. 2013 Aug;84(3):573-7. doi: 10.1016/j.ejpb.2013.01.002. Epub 2013 Jan 21.

  PMID: 23348235 BACKGROUND

• Roza AM, Shizgal HM. The Harris Benedict equation reevaluated: resting energy requirements and the body cell mass. Am J Clin Nutr. 1984 Jul;40(1):168-82. doi: 10.1093/ajcn/40.1.168.

  PMID: 6741850 BACKGROUND

Related Links

• WHO factsheet 311

Study Officials

• A.A.M. Masclee, MD, PhD

  Maastricht University Medical Center (MUMC+)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 21, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2015-12

Locations

NL (1)