Calcium-protein Co-ingestion and Gut Hormones

Obesity Clinical Trial

Official title:

The Acute Effects of Calcium-protein Co-ingestion on Gut Hormone Secretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370497
• Other study ID #: REACH EP 16/17_164B
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 28, 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). Rodent evidence suggests that calcium may potentiate the effects of protein ingestion on gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the addition of calcium to protein ingestion augments postprandial gut hormone availability in humans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 28, 2018
• Est. primary completion date: January 31, 2018
• 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.

• Weight 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:
• Milk Mineral Supplement
Milk Minerals containing 1000 mg calcium
• Whey Protein Hydrolysate
50 g whey protein hydrolysate

Locations

Country	Name	City	State
United Kingdom	Department for Health, 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).	Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).	120 min
Secondary	Postprandial plasma GIP area under the curve (mmol/L x 120 min)	Postprandial plasma GIP area under the curve (mmol/L x 120 min)	120 min
Secondary	Postprandial plasma PYY area under the curve (mmol/L x 120 min)	Postprandial plasma PYY area under the curve (mmol/L x 120 min)	120 min
Secondary	Subjective ratings of appetite (au)	Subjective ratings of appetite (au)	120 min