Calcium, Protein and Gut Hormones

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232034
• Other study ID #: REACH EP 16/17_164
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: August 2018
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2018
• Est. primary completion date: December 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Dietary Supplement:
• Calcium Citrate
1000 mg calcium as calcium citrate
• Milk Mineral Supplement
Milk Minerals containing 1000 mg calcium
• Whey Protein Hydrolysate
50 g whey protein hydrolysate

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).	Plasma glucagon-like peptide-1 (GLP-1) concentrations	120 min
Secondary	Postprandial plasma GIP area under the curve (mmol/L x 120 min)	Plasma glucose-dependent insulinotropic peptide (GIP) concentrations	120 min
Secondary	Postprandial plasma PYY area under the curve (mmol/L x 120 min)	Plasma peptide tyrosine tyrosine (PYY) concentrations.	120 min
Secondary	Subjective ratings of appetite (au)	Visual analogue scales of appetite ratings	120 min
Secondary	Energy metabolism (carbohydrate and fat oxidation)	Carbohydrate and fat oxidation (g/h) measured via indirect calorimetry	120 min
Secondary	Postprandial plasma glucose	Plasma glucose concentrations (mmol/L).	120 min
Secondary	Blood pressure	Systolic and diastolic blood pressure	120 min