Whey Protein Effects on Gycemic Control and Vascular Function

NCT01814358 | Withdrawn Phase 1

• 1 other identifier: Thomas whey 01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in normal weight and obese adults. This study will investigate the efficacy of drinking a whey protein beverage prior to eating for improved daily blood sugar control in normal weight and obese adults in the "real world." Also, the study will test this dietary approach to reduce blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24 normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects will wear a sensor to monitor daily blood sugar changes in response to their typically consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the monitoring period for measurement of blood vessel function after eating a breakfast cereal meal. Blood samples will be obtained before and after the meal to measure relevant health markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein (control) shake prior to each meal. Neither subjects nor researchers will know which protein ("double blind"). Subjects will receive the alternate protein intervention after another week or more ("crossover"). We think drinking the protein shake prior to meals will reduce daily blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results from eating the breakfast cereal.

Conditions

Blood Sugar (Glucose) Control; Blood Vessel (Vascular) Dysfunction

Outcome Measures

Primary Outcomes (1)

• Average 24 hour glucose

  The 24-hour glucose level (average of 48-hour monitoring period) for whey protein arm compared to other protein arm

  48 hours

Secondary Outcomes (4)

• Glycemic variability

  48 hours

• Post-meal percent change Brachial Artery Flow Mediated Dilation (FMD)

  120 minutes

• Post-meal monocyte inflammatory signaling

  60 minutes

• Post-meal percent change femoral artery blood flow (FBF)

  120 minutes

Study Arms (3)

Whey protein

EXPERIMENTAL

Subjects on this arm will receive whey protein

Dietary Supplement: Whey protein powder

Gelatin protein

ACTIVE COMPARATOR

Subjects on this arm will consume gelatin protein

Dietary Supplement: Control protein

Control arm

NO INTERVENTION

Subjects on this arm will receive no intervention

Interventions

Whey protein powder DIETARY_SUPPLEMENT

Subjects on this arm will consume 20g whey protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days

Whey protein

Control protein DIETARY_SUPPLEMENT

Subjects on this arm will consume 20g gelatin protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days

Gelatin protein

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years
• BMI between 18.5 and 25 or ≥ 30
• Willingness to provide written informed consent

You may not qualify if:

• Pregnant or breastfeeding currently or in prior 6 months
• Menopause in women
• Regular consumption of \> 1 serving per day of milk/yogurt
• Known heart arrhythmia
• Use of tobacco products
• Any disease/pathological condition known to influence outcomes
• Use of medications/dietary supplements known to influence outcomes
• Recent or planned changes in diet/exercise

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Study Officials

• Anthony Thomas, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

US (1)