Calcium, Protein and Gut Hormones

University of Bath

Status: Completed

Conditions: Diabetes; Obesity

Treatments: Dietary Supplement: Calcium Citrate; Dietary Supplement: Whey Protein Hydrolysate; Dietary Supplement: Milk Mineral Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03232034

REACH EP 16/17_164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

Calcium Citrate

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Calcium Citrate

Milk Mineral Supplement

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Milk Mineral Supplement

Milk mineral supplement plus Whey Protein Hydrolysate

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Whey Protein Hydrolysate

Dietary Supplement: Milk Mineral Supplement