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Repetitive Lipid Intake and Food Intake

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ClinicalTrials.gov Identifier: NCT03901157
Recruitment Status : Unknown
Verified February 2020 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : April 3, 2019
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Satiation Overweight and Obesity Satiety Response Dietary Supplement: Yogurt A: Active Dietary Supplement: Yogurt B: Control Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Repetitive Intake of Lipids in Alginate Gel on Food Intake and Satiety
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active yogurt
Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water
 Dietary Supplement: Yogurt A: Active
Free fat yogurt containing oil-filled alginate gels
Active Comparator: Control yogurt
Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water
 Dietary Supplement: Yogurt B: Control
Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels


Outcome Measures
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Primary Outcome Measures :
  1. Repetitive effect on ad libitum food intake [ Time Frame: 4 days ]
    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.


Secondary Outcome Measures :
  1. Acute effect on ad libitum food intake [ Time Frame: 3 and 6 hours ]
    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.

  2. Acute vs repetitive on ad libitum food intake [ Time Frame: 1 day and 4 days ]
    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).

  3. Food intake in normal living setting [ Time Frame: 2 and 3 days ]
    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.

  4. Feelings of satiety and GI symptoms (VAS scores) [ Time Frame: 1 day and 4 days ]
    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).

  5. Energy intake compensation [ Time Frame: 1 day and 4 days ]
    Percentage of energy intake compensation at lunch and dinner.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT03901157


Contacts
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Contact: Alvaro R Garcia Fuentes +31433883182 a.garciafuentes@maastrichtuniversity.nl

Locations
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Netherlands
Centre for Healthy Eating and Food Innovation Recruiting
Venlo, Limburg, Netherlands, 5928 RC
Contact: Alvaro R Garcia Fuentes, MSc.    +31 (0)43-3883182    a.garciafuentes@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Freddy Troost, Dr. Maastricht University
More Information
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Additional Information:

Publications:
Golding M, Wooster TJ, Day L, Xu M, Lundin L, Keogh J, et al. Impact of gastric structuring on the lipolysis of emulsified lipids. Soft Matter. 2011 Mar 22;7(7):3513-23.
Corstens MN, Berton-Carabin CC, Elichiry-Ortiz PT, Hol K, Troost FJ, Masclee AAM, et al. Emulsion-alginate beads designed to control in vitro intestinal lipolysis: Towards appetite control. J Funct Foods. 2017 Jul 1;34(Supplement C):319-28.
Li Y, Hu M, Du Y, Xiao H, McClements DJ. Control of lipase digestibility of emulsified lipids by encapsulation within calcium alginate beads. Food Hydrocoll. 2011 Jan 1;25(1):122-30
Zhang Z, Zhang R, Zou L, Chen L, Ahmed Y, Al Bishri W, et al. Encapsulation of curcumin in polysaccharide-based hydrogel beads: Impact of bead type on lipid digestion and curcumin bioaccessibility. Food Hydrocoll. 2016 Jul 1;58:160-70.
Rayment P, Wright P, Hoad C, Ciampi E, Haydock D, Gowland P, et al. Investigation of alginate beads for gastro-intestinal functionality, Part 1: In vitro characterisation. Food Hydrocoll. 2009 May 1;23(3):816-22.
Wright PJ, Ciampi E, Hoad CL, Weaver AC, van Ginkel M, Marciani L, et al. Investigation of alginate gel inhomogeneity in simulated gastro-intestinal conditions using magnetic resonance imaging and transmission electron microscopy. Carbohydr Polym. 2009 Jun 10;77(2):306-15.
Corstens MN, Berton-Carabin CC, Schroën K, Viau M, Meynier A. Emulsion encapsulation in calcium-alginate beads delays lipolysis during dynamic in vitro digestion. J Funct Foods. 2018 Jul;46:394-402.
Hoad C, Rayment P, Cox E, Wright P, Butler M, Spiller R, et al. Investigation of alginate beads for gastro-intestinal functionality, Part 2: In vivo characterisation. Food Hydrocoll. 2009 May 1;23(3):833-9.
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.
Zandstra EH, de Graaf C, Van Staveren WA. Influence of health and taste attitudes on consumption of low- and high-fat foods. Food Qual Prefer. 2001 Jan;12(1):75-82.

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03901157    
Other Study ID Numbers: NL66473.068.19
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
satiety
lipids in alginate gel
food intake
Additional relevant MeSH terms:
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Overweight
Body Weight