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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03901157
Other study ID # NL66473.068.19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 21, 2019
Est. completion date October 2020

Study information

Verified date February 2020
Source Maastricht University Medical Center
Contact Alvaro R Garcia Fuentes
Phone +31433883182
Email a.garciafuentes@maastrichtuniversity.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the present study the investigators will investigate the effect of consuming lipids inside alginate gel once a day during 4 days on food intake and satiety feelings in healthy people with overweight. All participants will receive a test yogurt that includes the oil-filled Ca-alginate gels and a control yogurt where the oil is not inside the gels.


Description:

Direct infusion of lipids into different parts of the human small intestine has demonstrated to decrease food intake and subjective appetite feelings, to increase production of the satiety hormones glucagon-like peptide 1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK), and diminishes gastrointestinal (GI) motility. Amongst oils with different degree of fatty acid saturation, safflower oil (high in linoleic acid, C18:2) was found the strongest inducer of the ileal brake. When ingested orally, however, the major part of dietary lipids will be digested and absorbed in the proximal small intestine and are not likely to induce the ileal brake mechanism. Incorporating small lipid droplets into millimeter-sized calcium (Ca)-alginate gel particles has shown promising results for ileal brake activation. Oral intake of these lipid containing gels have proven to reduce food intake in humans without inducing gastrointestinal symptoms. Contrastingly, to date little is known about repetitive activation of mechanisms of satiety and the effect on food intake. It is not known whether repetitive ileal brake activation provides a stronger brake or whether this will lead to a blunted response and adaptation.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Based on medical history and previous examination, no serious gastrointestinal complaints can be defined;

- Age between 18 and 65 years. This study will include healthy adult subjects (male and female);

- BMI between 25-30 kg/m2;

- Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions;

- Weight stable over at least the last 6 months (self-admitted; =5% weight change).

Exclusion Criteria:

- Self-admitted milk (-protein or lactose)- allergy/intolerance;

- Self-admitted history of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/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 medication that can influence study end-points (to be decided by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing;

- Administration of investigational drugs or participation in any scientific intervention study that may interfere with this study, to be decided by the principal investigator prior to the study;

- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery) upon judgement of the principal investigator;

- Dieting (medically prescribed, diabetic and vegetarian);

- Pregnancy, lactation (both self-admitted);

- Excessive alcohol consumption (>20 alcoholic units per week);

- Smoking;

- Self-admitted HIV-positive state.

Study Design


Intervention

Dietary Supplement:
Yogurt A: Active
Free fat yogurt containing oil-filled alginate gels
Yogurt B: Control
Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels

Locations

Country Name City State
Netherlands Centre for Healthy Eating and Food Innovation Venlo Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (53)

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Corstens MN, Troost FJ, Alleleyn AME, Klaassen T, Berton-Carabin CC, Schroën K, Masclee AAM. Encapsulation of lipids as emulsion-alginate beads reduces food intake: a randomized placebo-controlled cross-over human trial in overweight adults. Nutr Res. 2019 Mar;63:86-94. doi: 10.1016/j.nutres.2018.12.004. Epub 2018 Dec 8. — View Citation

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Hoad C, Rayment P, Risse V, Cox E, Ciampi E, Pregent S, et al. Encapsulation of lipid by alginate beads reduces bio-accessibility: An in vivo 13C breath test and MRI study. Food Hydrocoll. 2011 Jul 1;25(5):1190-200.

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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. — View Citation

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. — View Citation

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. Review. — View Citation

Maljaars PW, Symersky T, Kee BC, Haddeman E, Peters HP, Masclee AA. Effect of ileal fat perfusion on satiety and hormone release in healthy volunteers. Int J Obes (Lond). 2008 Nov;32(11):1633-9. doi: 10.1038/ijo.2008.166. Epub 2008 Sep 16. — View Citation

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Odunsi ST, Vázquez-Roque MI, Camilleri M, Papathanasopoulos A, Clark MM, Wodrich L, Lempke M, McKinzie S, Ryks M, Burton D, Zinsmeister AR. Effect of alginate on satiation, appetite, gastric function, and selected gut satiety hormones in overweight and obesity. Obesity (Silver Spring). 2010 Aug;18(8):1579-84. doi: 10.1038/oby.2009.421. Epub 2009 Dec 3. — View Citation

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* Note: There are 53 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Repetitive effect on ad libitum food intake Food intake of ad libitum meal (kcal), as measured during lunch (based on cumulated weight reduction of the food items provided) and during a pasta dinner (also based on weight reduction of the plate assuming a homogenous meal) after 4 days of consumption of the test product. 4 days
Secondary Acute effect on ad libitum food intake Food intake of ad libitum meal (kcal), as measured during lunch (based on cumulated weight reduction of the food items provided) and during a pasta dinner (also based on weight reduction of the plate assuming a homogenous meal) on the first day of consumption of the test product. 3 and 6 hours
Secondary Acute vs repetitive on ad libitum food intake The food intake on the first day of consumption of the test product (acute effect) will be compared with the food intake after 4 days of consumption of the test product (repetitive effect). 1 day and 4 days
Secondary Food intake in normal living setting Food intake of normal living setting (kcal), as calculated from food diaries filled by participants on day 2 and day 3 of the research periods. 2 and 3 days
Secondary Feelings of satiety and GI symptoms (VAS scores) Feelings of satiety and reduce feelings of hunger, as measured on VAS scores (satiety, fullness, hunger, desire to eat, desire to snack) and occurrence and severity of gastrointestinal (GI) symptoms that orally ingested lipids in alginate gel might give, as measured on VAS scores of GI symptoms (bloating, discomfort, pain, nausea). 1 day and 4 days
Secondary Energy intake compensation Percentage of energy intake compensation at lunch and dinner. 1 day and 4 days
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