Impact of Whey and Leucine on Glycaemia in Adults Without Diabetes

NCT03785951 | Unknown

• 1 other identifier: 17/56
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Higher than average blood sugar (glucose) levels are linked to an increased risk of developing type 2 diabetes. As such, there is interest in identifying dietary factors that could lower blood glucose to help reduce the number of people with this disease. Findings from some human studies indicate that dairy products, especially a milk protein (whey), may help the control of blood glucose levels. However, there is a need for further studies to confirm these findings in individuals without diabetes but with higher than average blood glucose levels.

Conditions

Pre Diabetes

Keywords

HbA1c; whey; postprandial glycaemia; cardiometabolic; vascular; leucine; branched chain amino acids (BCAA); glucose control; Milk protein

Outcome Measures

Primary Outcomes (2)

• Change in fasting and day long glucose levels

  Blood glucose levels will be measured using a clinical chemistry analyser

  Before and after each 8 week intervention.

• Change in fasting and day long insulin levels

  Blood insulin levels will be measured using ELISA

  Before and after each 8 week intervention.

Secondary Outcomes (15)

• Change in vascular reactivity measured by Laser Doppler Imaging with iontophoresis

  Before and after each 8 week intervention.

• Change in the total and HDL-cholesterol

  Before and after each 8 week intervention

• Change in fructosamine

  Before and after each 8 week intervention

• Change in C-reactive protein

  Before and after each 8 week intervention

• Change in pulse wave analysis

  Before and after each 8 week intervention

Other Outcomes (1)

• Metabonomics

  Before and after each 8 week intervention

Study Arms (3)

Whey Protein Isolate

EXPERIMENTAL

Subjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks

Dietary Supplement: Whey Protein Isolate; Dietary Supplement: Wheat Protein; Dietary Supplement: Wheat Protein with Leucine

Wheat Protein

EXPERIMENTAL

Subjects are asked to supplement their habitual diet with 56 g of wheat protein a day for 8 weeks

Dietary Supplement: Whey Protein Isolate; Dietary Supplement: Wheat Protein; Dietary Supplement: Wheat Protein with Leucine

Wheat protein with leucine

EXPERIMENTAL

Subjects are asked to supplement their habitual diet with 56 g of wheat protein with leucine a day for 8 weeks

Dietary Supplement: Whey Protein Isolate; Dietary Supplement: Wheat Protein; Dietary Supplement: Wheat Protein with Leucine

Interventions

Whey Protein Isolate DIETARY_SUPPLEMENT

Whey protein product isolated from whole milk. 79% Protein with minimal carbohydrate and fat. 50 grams of total supplemental protein/amino acids from whey protein powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake.

Wheat Protein; Wheat protein with leucine; Whey Protein Isolate

Wheat Protein DIETARY_SUPPLEMENT

Enzymatically hydrolysed wheat protein containing wheat peptides. 75% Protein with minimal carbohydrate and fat. 50 grams of total supplemental protein/amino acids from whet protein peptide powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake.

Wheat Protein; Wheat protein with leucine; Whey Protein Isolate

Wheat Protein with Leucine DIETARY_SUPPLEMENT

Enzymatically hydrolysed wheat protein containing wheat peptides with and additional 1.4g of L-leucine. 75% Protein with minimal carbohydrate and fat and a L-leucine concentration equal to whey protein isolate. 50 grams of total supplemental protein/amino acids from wheat protein peptide powder, with added leucine to equal the total content of the whey protein condition, consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks.

Wheat Protein; Wheat protein with leucine; Whey Protein Isolate

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 20-35 kg/m2
• HbA1c (5.7 - 6.5%) or (38.8 - 47.5 mmol/mol)
• Fasting glucose 5.5-6.9 mmol/l
• Fasting total cholesterol \<7.5mmol/l
• Fasting triacylglycerol \<4.0 mmol/l
• Not having a milk, gluten or wheat allergy or lactose intolerability
• Not having diabetes (HbA1c \< 47 mmol/mol) or \< 6.5%
• Not suffering from cardiovascular, renal, gastrointestinal, respiratory, endocrine or liver disease
• Not having hypertension
• Not diagnosed with cancer
• Not having surgery in the previous 6 months
• Not consuming more than the recommended intake of alcohol (\>14 unit/wk)
• Not being a blood donor 3 months prior to or during the study.
• Not taking extra protein powder supplements in the previous 2 months
• Not anaemic (Haemoglobin ≥115 g/l for women and ≥ 130 g/l for men)

You may not qualify if:

• Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions

Sponsors & Collaborators

• University of Reading: lead
• Barnham Benevolent Foundation: collaborator
• Jason and Daphne Mermikides Charitable Trust: collaborator

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (2)

• Pal S, Ellis V, Dhaliwal S. Effects of whey protein isolate on body composition, lipids, insulin and glucose in overweight and obese individuals. Br J Nutr. 2010 Sep;104(5):716-23. doi: 10.1017/S0007114510000991. Epub 2010 Apr 9.

  PMID: 20377924 BACKGROUND

• Nilsson M, Stenberg M, Frid AH, Holst JJ, Bjorck IM. Glycemia and insulinemia in healthy subjects after lactose-equivalent meals of milk and other food proteins: the role of plasma amino acids and incretins. Am J Clin Nutr. 2004 Nov;80(5):1246-53. doi: 10.1093/ajcn/80.5.1246.

  PMID: 15531672 BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Leucine

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Julie Lovegrove, Professor

  University of Reading

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Lovegrove, Professor

CONTACT

0044(0)1183786418; j.a.lovegrove@reading.ac.uk

Drew Price, Masters

CONTACT

00447905106167; a.j.price@pgr.reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Coded protein products will be used.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double-blind, randomised, controlled, 3-way, cross-over study

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 24, 2018
• Study Start: December 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

GB (1)