SatiationNCT03901157
Repetitive Lipid Intake and Food Intake
A study testing Yogurt A: Active in people with Satiation and Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiation, Overweight and Obesity, Satiety Response
- What is being tested?
- Yogurt A: Active
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Oct 2019to Oct 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
Show all 10Show fewer
- Pregnancy, lactation (both self-admitted);
- Excessive alcohol consumption (>20 alcoholic units per week);
- Smoking;
- Self-admitted HIV-positive state.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Centre for Healthy Eating and Food Innovation
Venlo, Limburg, 5928 RC
Alvaro R Garcia Fuentes, MSc., +31 (0)43-3883182, a.garciafuentes@maastrichtuniversity.nl
About this study
Official title: The Effect of Repetitive Intake of Lipids in Alginate Gel on Food Intake and Satiety
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.
Read the 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.
- Conditions
- Satiation, Overweight and Obesity, Satiety Response
- Being tested
- Yogurt A: Active, Yogurt B: Control
- Keywords
- satiety, lipids in alginate gel, food intake
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt A: ActiveDietary supplement
Free fat yogurt containing oil-filled alginate gels
Yogurt B: ControlDietary supplement
Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels
| Study group | Role | What they receive |
|---|---|---|
| Active yogurt | Experimental | Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water Receives: Dietary Supplement: Yogurt A: Active |
| Control yogurt | Active comparator | Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water Receives: Dietary Supplement: Yogurt B: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Secondary outcomes (5)
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.
Measured: 3 and 6 hours
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).
Measured: 1 day and 4 days
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.
Measured: 2 and 3 days
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).
Measured: 1 day and 4 days
Energy intake compensation
Percentage of energy intake compensation at lunch and dinner.
Measured: 1 day and 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start21 Oct 2019
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for SatiationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Freddy Troost, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901157
- Sponsor's protocol ID
- NL66473.068.19
- Status last verified
- Feb 2020
- First submitted
- 2 Apr 2019
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blomain ES, Dirhan DA, Valentino MA, Kim GW, Waldman SA. Mechanisms of Weight Regain following Weight Loss. ISRN Obes. 2013 Apr 16;2013:210524. doi: 10.1155/2013/210524. eCollection 2013.
PubMed 24533218Nicklas JM, Huskey KW, Davis RB, Wee CC. Successful weight loss among obese U.S. adults. Am J Prev Med. 2012 May;42(5):481-5. doi: 10.1016/j.amepre.2012.01.005.
PubMed 22516488Sumithran P, Proietto J. The defence of body weight: a physiological basis for weight regain after weight loss. Clin Sci (Lond). 2013 Feb;124(4):231-41. doi: 10.1042/CS20120223.
PubMed 23126426van 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.
PubMed 24957485Maljaars 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.
PubMed 21736790Alleleyn AM, van Avesaat M, Troost FJ, Masclee AA. Gastrointestinal Nutrient Infusion Site and Eating Behavior: Evidence for A Proximal to Distal Gradient within the Small Intestine? Nutrients. 2016 Feb 26;8(3):117. doi: 10.3390/nu8030117.
PubMed 26927170Spiller RC, Trotman IF, Higgins BE, Ghatei MA, Grimble GK, Lee YC, Bloom SR, Misiewicz JJ, Silk DB. The ileal brake--inhibition of jejunal motility after ileal fat perfusion in man. Gut. 1984 Apr;25(4):365-74. doi: 10.1136/gut.25.4.365.
PubMed 6706215Welch IM, Sepple CP, Read NW. Comparisons of the effects on satiety and eating behaviour of infusion of lipid into the different regions of the small intestine. Gut. 1988 Mar;29(3):306-11. doi: 10.1136/gut.29.3.306.
PubMed 3356362Ryan AT, Luscombe-Marsh ND, Saies AA, Little TJ, Standfield S, Horowitz M, Feinle-Bisset C. Effects of intraduodenal lipid and protein on gut motility and hormone release, glycemia, appetite, and energy intake in lean men. Am J Clin Nutr. 2013 Aug;98(2):300-11. doi: 10.3945/ajcn.113.061333. Epub 2013 Jun 26.
PubMed 23803895Maljaars 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.
PubMed 18794896Maljaars 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.
PubMed 19225118Feinle-Bisset C, Patterson M, Ghatei MA, Bloom SR, Horowitz M. Fat digestion is required for suppression of ghrelin and stimulation of peptide YY and pancreatic polypeptide secretion by intraduodenal lipid. Am J Physiol Endocrinol Metab. 2005 Dec;289(6):E948-53. doi: 10.1152/ajpendo.00220.2005. Epub 2005 Jul 5.
PubMed 15998659Maljaars 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.
PubMed 18692080Golding 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.
Smith GP. Hervey, Harris, and the parabiotic search for lipostatic signals. Appetite. 2013 Feb;61(1):97-9. doi: 10.1016/j.appet.2012.08.024. Epub 2012 Sep 13.
PubMed 22983368
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetitive Intake of Lipids in Alginate Gel on Food Intake and Satiety
- ClinicalTrials.gov ID
- NCT03901157
- Acronym / sponsor ID
- NL66473.068.19
- Conditions
- Satiation, Overweight and Obesity, Satiety Response
- Keywords
- satiety, lipids in alginate gel, food intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active yogurt | Experimental | Dietary Supplement: Yogurt A: ActiveContains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water |
| Control yogurt | Active comparator | Dietary Supplement: Yogurt B: ControlContains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt A: ActiveFree fat yogurt containing oil-filled alginate gels | Dietary supplement | Active yogurt |
| Yogurt B: ControlFree fat yogurt containing the same amount of fat as the active one, and empty alginate gels | Dietary supplement | Control yogurt |
Primary outcome
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.
5 secondary outcomes
Acute effect on ad libitum food intake
Time frame: 3 and 6 hours
Acute vs repetitive on ad libitum food intake
Time frame: 1 day and 4 days
Food intake in normal living setting
Time frame: 2 and 3 days
Feelings of satiety and GI symptoms (VAS scores)
Time frame: 1 day and 4 days
Energy intake compensation
Time frame: 1 day and 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Background: PubMed 24533218Blomain ES, Dirhan DA, Valentino MA, Kim GW, Waldman SA. Mechanisms of Weight Regain following Weight Loss. ISRN Obes. 2013 Apr 16;2013:210524. doi: 10.1155/2013/210524. eCollection 2013.
- Background: PubMed 22516488Nicklas JM, Huskey KW, Davis RB, Wee CC. Successful weight loss among obese U.S. adults. Am J Prev Med. 2012 May;42(5):481-5. doi: 10.1016/j.amepre.2012.01.005.
- Background: PubMed 23126426Sumithran P, Proietto J. The defence of body weight: a physiological basis for weight regain after weight loss. Clin Sci (Lond). 2013 Feb;124(4):231-41. doi: 10.1042/CS20120223.
- Background: PubMed 24957485van 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.
- Background: PubMed 21736790Maljaars 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.
- Background: PubMed 26927170Alleleyn AM, van Avesaat M, Troost FJ, Masclee AA. Gastrointestinal Nutrient Infusion Site and Eating Behavior: Evidence for A Proximal to Distal Gradient within the Small Intestine? Nutrients. 2016 Feb 26;8(3):117. doi: 10.3390/nu8030117.
- Background: PubMed 6706215Spiller RC, Trotman IF, Higgins BE, Ghatei MA, Grimble GK, Lee YC, Bloom SR, Misiewicz JJ, Silk DB. The ileal brake--inhibition of jejunal motility after ileal fat perfusion in man. Gut. 1984 Apr;25(4):365-74. doi: 10.1136/gut.25.4.365.
- Background: PubMed 3356362Welch IM, Sepple CP, Read NW. Comparisons of the effects on satiety and eating behaviour of infusion of lipid into the different regions of the small intestine. Gut. 1988 Mar;29(3):306-11. doi: 10.1136/gut.29.3.306.
- Background: PubMed 23803895Ryan AT, Luscombe-Marsh ND, Saies AA, Little TJ, Standfield S, Horowitz M, Feinle-Bisset C. Effects of intraduodenal lipid and protein on gut motility and hormone release, glycemia, appetite, and energy intake in lean men. Am J Clin Nutr. 2013 Aug;98(2):300-11. doi: 10.3945/ajcn.113.061333. Epub 2013 Jun 26.
- Background: PubMed 18794896Maljaars 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.
- Background: PubMed 19225118Maljaars 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.
- Background: PubMed 15998659Feinle-Bisset C, Patterson M, Ghatei MA, Bloom SR, Horowitz M. Fat digestion is required for suppression of ghrelin and stimulation of peptide YY and pancreatic polypeptide secretion by intraduodenal lipid. Am J Physiol Endocrinol Metab. 2005 Dec;289(6):E948-53. doi: 10.1152/ajpendo.00220.2005. Epub 2005 Jul 5.
- Obesity and overweightLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Troost, Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt A: Active in people with Satiation and Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Feb 2020. 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 Netherlands. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alvaro R Garcia Fuentes (+31433883182, a.garciafuentes@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repetitive effect on ad libitum food intake (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901157, which also lists 53 linked publications.
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 24 Feb 2020.