Effect of encapsulated nutrients on gut peptide secretio

Completed

• Conditions: Metabolic and endocrine diseases; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN10757078
• Lead Sponsor: Cambridge Institute for Medical Research (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-18
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

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

Exclusion Criteria

1. Age <18 or >65 years old at enrolment
2. BMI <18 or >45 kg/m2 at enrolment
3. Pregnancy or breast feeding
4. Any current medical disorder or history of disorder with potential to influence parameters measured in this study
5. Any current medical disorder or history of disorder likely to influence the ability follow the study protocol safely and effectively
6. Any current medication or history of medication likely to influence parameters measured in this study. For example, patients with T2DM should be on oral medication only and not on exogenous insulin or injectable GLP-1 mimetics
7. Current or historical drug or alcohol abuse
8. Current smoking habit
9. Any concern that a potential participant may not understand the nature or requirements of the study sufficiently to consent to participation
10. Any other circumstance or condition not covered above which would make participation unreasonable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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. <br>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. <br>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. <br>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.