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The aim of this project is to investigate the effect of intragastric (ig) D-allulose on metabolic parameters in general and to investigate the effect of sweet taste receptor blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and appetite-related sensations to ig administration of erythritol and D-allulose.
Erythritol (natural non-caloric sweetener) could be an ideal candidate substitute for sugar as it may reduce caloric intake without compensatory overeating or earlier return of hunger. Moreover, it may serve as a physiological tool to disentangle the effects of gastrointestinal (GI) sweet taste receptor stimulation, (an)orexigenic hormone secretion, and glucose metabolism/caloric content on food intake regulation in vivo in humans. However, its effects on appetite, satiation, and satiety have not been studied systematically. Moreover, the mechanisms underlying erythritol-induced anorexigenic GI hormone release have not been investigated so far.
D-allulose is a sugar substitute with almost zero calories and is naturally occurring in small quantities. Apart from its use as sugar replacement, D-allulose seems to favorably affect glycemic control and metabolism as could be shown in animal trials and in a few human trials. However, to date the effects of D-allulose on GI hormone secretion, appetite-related sensations and glycemic control, are not or insufficiently studied in humans.
The aim of this project is therefore to investigate the effect of intragastric (ig) D-allulose on metabolic parameters in general and to investigate the effect of sweet taste receptor blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and appetite-related sensations to ig administration of erythritol and D-allulose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythritol | Active Comparator | 18 volunteers receive 50g erythritol dissolved in 300mL tap water via a nasogastric tube |
|
| Erythritol + lactisole | Active Comparator | 18 volunteers receive 50g erythritol with lactisol (450ppm) dissolved in 300mL tap water via a nasogastric tube |
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| D-allulose | Active Comparator | 18 volunteers receive 25g D-allulose dissolved in 300mL tap water via a nasogastric tube |
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| D-allulose + lactisole | Active Comparator | 18 volunteers receive 25g D-allulose with lactisole (450ppm) dissolved in 300mL tap water via a nasogastric tube |
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| Tap water | Placebo Comparator | 18 volunteers receive 300mL tap water via a nasogastric tube |
|
| Tap water + lactisole |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythritol | Dietary Supplement | 50g erythritol dissolved in 300mL tap water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects on GI hormone response - GLP-1 | Plasma GLP-1 will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). | Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Effects on GI hormone response - PYY | Plasma PYY, and ghrelin will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). | Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Effects on GI hormone response - ghrelin | Plasma ghrelin will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). | Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Effects on GI hormone response - CCK | Plasma cholecystokinin (CCK) levels will be measured with a sensitive radioimmunoassay using a highly specific antiserum. | Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Effects on GI hormone response - motilin | Plasma motilin levels will be measured with a sensitive radioimmunoassay as previously described using 125I [Nle13] human motilin as tracer and rabbit anti-human Nle13 motilin antibody (final dilution 1/12000). |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on glycemic control - plasma glucose | Blood glucose concentrations will be measured by a commercial hexokinase-glucose-6-phosphate-dehydrogenase method (Roche, Basel, Switzerland). Insulin, c-peptide and glucagon will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). The lowest level of insulin that can be detected by this assay is 87 pg/mL when using a 25 µL sample. The lowest level of c-peptide that can be detected by this assay is 9.5 pg/mL when using a 25 µL sample. The lowest level of glucagon that can be detected by this assay is 13 pg/mL when using a 25 µL sample. The intra-assay coefficient of variation for all peptides (insulin, c-peptide and glucagon) is below 10%, whereas the inter-assay coefficient of variation is below 15%. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on GI tolerance | GI symptoms will be assessed by use of a checklist including the following questions: abdominal pain, nausea, vomiting, diarrhoea, borborygmi, abdominal distension, eructation and increased flatus. | Changes from baseline to four hours after treatment. GI tolerance will be recorded at time=-10, time=30, time=60, time=90, time=120, time=150, time=180, and time=240minutes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Christin Meyer-Gerspach, PD, PhD | St. Clara Research Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Claraspital | Basel | 4002 | Switzerland |
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| ID | Term |
|---|---|
| D004896 | Erythritol |
| C495512 | lactisole |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Placebo Comparator |
18 volunteers receive 300mL tap water + lactisole (450ppm) via a nasogastric tube |
|
| Erythritol + lactisole | Dietary Supplement | 50g erythritol + lactisole (450ppm) dissolved in 300mL tap water |
|
|
| D-allulose | Dietary Supplement | 25g D-allulose dissolved in 300mL tap water |
|
| D-allulose + lactisole | Dietary Supplement | 25g D-allulose + lactisole (450ppm) dissolved in 300mL tap water |
|
| Tap water | Dietary Supplement | 300mL tap water |
|
| Tap water + lactisole | Dietary Supplement | 300mL tap water + lactisole (450ppm) |
|
| Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Effects on glycemic control - plasma insulin | Insulin will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). The lowest level of insulin that can be detected by this assay is 87 pg/mL when using a 25 µL sample. The intra-assay coefficient of variation for insulin is below 10%, whereas the inter-assay coefficient of variation is below 15%. | Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Effects on glycemic control - plasma c-peptide | C-peptide will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). The lowest level of c-peptide that can be detected by this assay is 9.5 pg/mL when using a 25 µL sample. The intra-assay coefficient of variation for c-peptide is below 10%, whereas the inter-assay coefficient of variation is below 15%. | Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Effects on glycemic control - plasma glucagon | Glucagon will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). The lowest level of glucagon that can be detected by this assay is 13 pg/mL when using a 25 µL sample. The intra-assay coefficient of variation for glucagon is below 10%, whereas the inter-assay coefficient of variation is below 15%. | Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration). |
| Effects on gastric emptying rate | Gastric emptying rate will be determined using a 13C-sodium acetate breath test. | Changes from baseline to four hours after treatment. Breath samples will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180 and 240minutes (after administration). |
| Effects on blood lipids | Analyses of blood lipids are carried out in the hospital laboratory. | Changes from baseline to two hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, and 120minutes (after administration). |
| Effects on uric acid | Analyses of uric acid are carried out in the hospital laboratory. | Changes from baseline to two hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, and 120minutes (after administration). |
| Effects on hsCRP (high sensitive c-reactive protein) | Analyses of hsCRP are carried out in the hospital laboratory. | Changes from baseline to two hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, and 120minutes (after administration). |
| Effects on appetite-related sensations | Appetite perceptions (feelings of: a) hunger, b) satiety) are assessed by visual analogue scale (VAS). Visual analogue scales consist of a horizontal, unstructured, 10-cm line representing the minimum (0.0 points) to the maximum rating (10.0 points). Subjects assign a vertical mark across the line to indicate the magnitude of their subjective sensation at the present time point. The measurement is quantified by the distance from the left end of the line (minimum rating) to the subject's vertical mark. | Changes from baseline to four hours after treatment. Visual analogue scales will be recorded at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180 and 240minutes (after administration). |