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Calcium, Protein and Gut Hormones

Not Applicable
Completed
Conditions
Obesity
Diabetes
Interventions
Dietary Supplement: Calcium Citrate
Dietary Supplement: Milk Mineral Supplement
Dietary Supplement: Whey Protein Hydrolysate
Registration Number
NCT03232034
Lead Sponsor
University of Bath
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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%).
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Calcium CitrateCalcium CitrateCalcium 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.
Milk mineral supplement plus Whey Protein HydrolysateWhey Protein HydrolysateMilk 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.
Milk Mineral SupplementMilk Mineral SupplementMilk 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.
Milk mineral supplement plus Whey Protein HydrolysateMilk Mineral SupplementMilk 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.
Primary Outcome Measures
NameTimeMethod
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).120 min

Plasma glucagon-like peptide-1 (GLP-1) concentrations

Secondary Outcome Measures
NameTimeMethod
Postprandial plasma GIP area under the curve (mmol/L x 120 min)120 min

Plasma glucose-dependent insulinotropic peptide (GIP) concentrations

Postprandial plasma PYY area under the curve (mmol/L x 120 min)120 min

Plasma peptide tyrosine tyrosine (PYY) concentrations.

Energy metabolism (carbohydrate and fat oxidation)120 min

Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry

Postprandial plasma glucose120 min

Plasma glucose concentrations (mmol/L).

Blood pressure120 min

Systolic and diastolic blood pressure

Subjective ratings of appetite (au)120 min

Visual analogue scales of appetite ratings

Trial Locations

Locations (1)

University of Bath

🇬🇧

Bath, United Kingdom

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