Calcium, Protein and Gut Hormones

Study Overview
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Brief Summary
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Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal ingestion in humans. However, these nutrients may interact synergistically (and with other minerals in milk) such that specific co-ingestion of these nutrients is required to obtain the full therapeutic potential for metabolism and energy balance. This proposal is to perform a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone responses.

Detailed Description
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Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks: 1) calcium citrate (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose). Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY) circulating in the bloodstream. We will also ask participants to complete an appetite questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess their appetite sensations. After the 120-minute time point, we will remove the cannula and the trial day will be complete.

Official Title
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The Role of Dietary Milk Minerals and Protein in Gut Hormone Secretion

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Dietary Supplement: Calcium Citrate
* Dietary Supplement: Milk Mineral Supplement
* Dietary Supplement: Whey Protein Hydrolysate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women age between 18-65 yrs. Able to consume provided supplement. Weigh stable for the past 3 month (no change within 3%). Exclusion Criteria: Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease Not between the ages of 18-65 years A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared) Taking medications that may influence your metabolism Plans to change your lifestyle (diet and/or physical activity) during the study period Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions. Current smoker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Calcium Citrate<br>Calcium citrate (1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. | Dietary Supplement: Calcium Citrate<br>* 1000 mg calcium as calcium citrate<br>|
| Active Comparator: Milk Mineral Supplement<br>Milk mineral supplement (equating to 1000 mg calcium) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. | Dietary Supplement: Milk Mineral Supplement<br>* Milk Minerals containing 1000 mg calcium<br>|
| Experimental: Milk mineral supplement plus Whey Protein Hydrolysate<br>Milk mineral supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g) will be consumed by participants in the morning between 8-10 am after 8-14 h fasting. Blood samples, appetite scales and expired breath samples will be taken in a regular intervals for 2 h after ingestion. | Dietary Supplement: Milk Mineral Supplement<br>* Milk Minerals containing 1000 mg calcium<br>Dietary Supplement: Whey Protein Hydrolysate<br>* 50 g whey protein hydrolysate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min). | Plasma glucagon-like peptide-1 (GLP-1) concentrations | 120 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial plasma GIP area under the curve (mmol/L x 120 min) | Plasma glucose-dependent insulinotropic peptide (GIP) concentrations | 120 min | 
| Postprandial plasma PYY area under the curve (mmol/L x 120 min) | Plasma peptide tyrosine tyrosine (PYY) concentrations. | 120 min | 
| Subjective ratings of appetite (au) | Visual analogue scales of appetite ratings | 120 min | 
| Energy metabolism (carbohydrate and fat oxidation) | Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry | 120 min | 
| Postprandial plasma glucose | Plasma glucose concentrations (mmol/L). | 120 min | 
| Blood pressure | Systolic and diastolic blood pressure | 120 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium citrate, dairy product, whey protein, appetite, metabolism