Whey Protein Effects on Gycemic Control and Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Whey protein

Subjects on this arm will receive whey protein

Group Type EXPERIMENTAL

Whey protein powder

Intervention Type 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

Gelatin protein

Subjects on this arm will consume gelatin protein

Group Type ACTIVE_COMPARATOR

Control protein

Intervention Type 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

Control arm

Subjects on this arm will receive no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Whey protein powder

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

Intervention Type DIETARY_SUPPLEMENT

Control protein

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes