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Calcium, Protein and Gut Hormones

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03232034
Enrollment
20
Registered
2017-07-27
Start date
2017-05-01
Completion date
2018-01-31
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Diabetes

Keywords

Calcium citrate, dairy product, whey protein, appetite, metabolism

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.

Interventions

DIETARY_SUPPLEMENTWhey Protein Hydrolysate

50 g whey protein hydrolysate

DIETARY_SUPPLEMENTCalcium Citrate

1000 mg calcium as calcium citrate

DIETARY_SUPPLEMENTMilk Mineral Supplement

Milk Minerals containing 1000 mg calcium

Sponsors

University of Bath
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Participants and Researchers will be blinded to the interventions.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).120 minPlasma glucagon-like peptide-1 (GLP-1) concentrations

Secondary

MeasureTime frameDescription
Postprandial plasma GIP area under the curve (mmol/L x 120 min)120 minPlasma glucose-dependent insulinotropic peptide (GIP) concentrations
Postprandial plasma PYY area under the curve (mmol/L x 120 min)120 minPlasma peptide tyrosine tyrosine (PYY) concentrations.
Blood pressure120 minSystolic and diastolic blood pressure
Energy metabolism (carbohydrate and fat oxidation)120 minCarbohydrate and fat oxidation (g/h) measured via indirect calorimetry
Postprandial plasma glucose120 minPlasma glucose concentrations (mmol/L).
Subjective ratings of appetite (au)120 minVisual analogue scales of appetite ratings

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026