Calcium-protein Co-ingestion and Gut Hormones

NCT03370497 | Completed

• 1 other identifier: REACH EP 16/17_164B
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  120 min

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

  120 min

• Subjective ratings of appetite (au)

  120 min

Study Arms (2)

Whey protein hydrolysate

ACTIVE COMPARATOR

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.

Dietary Supplement: Whey Protein Hydrolysate

Whey protein hydrolysate plus milk mineral supplement

EXPERIMENTAL

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.

Dietary Supplement: Milk Mineral Supplement; Dietary Supplement: Whey Protein Hydrolysate

Interventions

Milk Mineral Supplement DIETARY_SUPPLEMENT

Milk Minerals containing 1000 mg calcium

Whey protein hydrolysate plus milk mineral supplement

Whey Protein Hydrolysate DIETARY_SUPPLEMENT

50 g whey protein hydrolysate

Whey protein hydrolysate; Whey protein hydrolysate plus milk mineral supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Location

Related Publications (1)

• Chen YC, Smith HA, Hengist A, Chrzanowski-Smith OJ, Mikkelsen UR, Carroll HA, Betts JA, Thompson D, Saunders J, Gonzalez JT. Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults. Eur J Nutr. 2020 Sep;59(6):2449-2462. doi: 10.1007/s00394-019-02092-4. Epub 2019 Sep 17.

  PMID: 31531707 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomised, double-blind crossover

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 12, 2017
• Study Start: October 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: February 28, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)