Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
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2012
INTERVENTION: Each participant will receive both placebo and active treatments at different visits. Each participant will receive one capsule type at one dose per visit with an interval period of at least 24 hours between visits. Each participant will have 3‐6 visits. All capsules will be taken orally. For example: Visit 1‐ Active dose at level 1 Visit 2‐ Placebo Visit 3‐ Active dose at level 2 The active capsules contain one of the following ingredients which will be tested individually against placebo: Glutamine ‐? a naturally‐occurring protein. Approximate doses 0.6‐6g Mono‐oleoyl glycerol ?‐ found naturally in olive oil. Approximate doses 0.3‐6g Sodium taurocholate ?‐ a normal component of bile. Approximate doses 0.5‐7g The placebo capsule contains microcrystalline cellulose. CONDITION: Metabolic and endocrine diseases ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: Concentrations of gut hormones (such as GLP‐1, GIP or PYY) will be measured in plasma at timepoints 0, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5 and 6 hours after capsule ingestion. The outcome will be assessed by peak hormone concentrations and area under the curve calculations. SECONDARY OUTCOME: 1. Glucose and insulin levels will be measured at timepoints 0, 1, 2, 2.5, 3, 3.5 and 4 hours following a 75g oral glucose tolerance test. The outcome will be assessed by peak concentrations of glucose and insulin, concentrations at 2, 3 and 4 hours post‐ingestion and area under the curve calculations. ; 2. Hunger and satiety will be measured using a visual analogue scale. The outcome will be measured by peak values of hunger and satiety and area under the curve calculations. ; 3. Food quantity ingested and speed of intake will be assessed using an ad libitum meal and universal eating monitor. The outcome will be measured by total caloric content ingested, calories ingested at timepoints 5, 10, 20 and 30 minutes after the start of the meal, and area under the curve for caloric intake. ; 4. Safety and tolerability will be assessed using a symptom diary with a severity scale. Peak severity score and area under the curve measurements will be assessed for adverse effects in comparison to placebo. INCLUSION CRITERIA: Tasks 1‐2 1. Healthy male or female subjects, aged 18 to 65 years. 2. BMI 18 to 45 kg/m2. 3. Willingness to attend the CRF on 4‐5 occasions at approximately 12 week intervals for administration of capsules. Tasks 3‐5 1. Male or female subjects, aged 18 to 65 years with T2DM or glucose intolerance as diagnosed by a previous OGTT and /or fasting glucose level and HbA1c level. 2. BMI 18 to 45 kg/m2. 3. Willingness to attend the CRF on 4‐5 occasions and take capsules three times daily for a total period of four weeks 4. Male & female participants 5. Aged 18 ‐ 65 years
Epistemonikos ID: 4d0438e39cae86a1087c1d24c218e37e446151dc
First added on: Aug 22, 2024