Trial Outcomes & Findings for Protein Quality on Appetite Control, Reward-driven Eating, & Subsequent Food Intake (NCT NCT02285907)

NCT ID: NCT02285907

Last Updated: 2019-05-15

Results Overview

Eating initiation will be measured as the time lapse between consuming the intervention and requesting dinner.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

1 Day

Results posted on

2019-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants Twenty-four participants signed the consent but two withdrew prior to beginning testing day procedures. One participant was withdrawn due to protocol violations prior to beginning the fourth treatment. All 21 remaining participants completed all interventions of a randomized cross-over study to compare 400-kcal lunch meals varying in protein quality but matched for either macronutrient or fiber content or serving size (Macronutrient and Fiber Matched BEEF, Macronutrient and Fiber Matched SOY, Serving Size Matched BEEF, and Serving Size Matched Soy). The participants completed 2 testing days per lunch treatment. On the first day, participants completed the 8 hour testing day with repeated blood sampling and appetite questionnaires. During the second testing day, pre- and post-lunch food cue-stimulated fMRI brain scans were completed. Within each treatment, the first and second testing days were separated by 2-7 days. However, there was 7-14 days in between each treatment.
Overall Study STARTED	21
Overall Study Began 1st Intervention	21
Overall Study Began 2nd Intervention	21
Overall Study Began 3rd Intervention	21
Overall Study Began 4th Intervention	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Protein Quality on Appetite Control, Reward-driven Eating, & Subsequent Food Intake

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=21 Participants All 21 participants completed all interventions of a randomized cross-over study to compare 400-kcal lunch meals varying in protein quality but matched for either macronutrient or fiber content or serving size. In the macronutrient and fiber-matched comparisons, both lunch meals contained 24-g protein and 2-g fiber, differing only in the type of protein consumed (beef vs. soy). In the serving size-matched comparisons, the lunch meals contained 1 serving of beef (24-g protein/1-g fiber) or 1 serving of soy (14-g protein/5-g fiber). The participants completed 2 testing days per lunch treatment. On the first day, participants completed the 8 hour testing day with repeated blood sampling and appetite questionnaires. During the second testing day, pre- and post-lunch food cue-stimulated fMRI brain scans were completed. Within each treatment, the first and second testing days were separated by 2-7 days. However, there was 7-14 days in between each treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Eating initiation will be measured as the time lapse between consuming the intervention and requesting dinner.

Outcome measures

Outcome measures
Measure	Macronutrient and Fiber Matched Beef n=20 Participants The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Macronutrient and Fiber Matched Soy n=20 Participants The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).	Serving Size Matched Beef n=20 Participants The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Serving Size Matched Soy n=20 Participants The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
Eating Initiation	250 minutes Standard Error 15	270 minutes Standard Error 20	245 minutes Standard Error 25	250 minutes Standard Error 20

PRIMARY outcome

Timeframe: 1 Day

Ad libitum dinner and snacks were provided. Energy content and macronutrient content of these eating occasions were assessed.

Outcome measures

Outcome measures
Measure	Macronutrient and Fiber Matched Beef n=20 Participants The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Macronutrient and Fiber Matched Soy n=20 Participants The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).	Serving Size Matched Beef n=20 Participants The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Serving Size Matched Soy n=20 Participants The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
Subsequent Food Intake	240 kilocalories Standard Error 74	970 kilocalories Standard Error 82	920 kilocalories Standard Error 75	900 kilocalories Standard Error 72

PRIMARY outcome

Timeframe: - 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min

Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days. The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely." Each reported score can be a minimum of 0 and a maximum of 100 mm. niAUC was calculated for by computing the summation of the average change from baseline score (units of mm) for each time point and the subsequent time point, multiplied by the difference in time (min) between the two measures. For reported feelings of hunger, a higher score can be interpreted as "feeling more hungry." For fullness, higher can be interpreted as "feeling more full." Questionnaires were asked at baseline and about every 30 minutes throughout the day for a total of 20 questionnaires.

Outcome measures

Outcome measures
Measure	Macronutrient and Fiber Matched Beef n=20 Participants The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Macronutrient and Fiber Matched Soy n=20 Participants The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).	Serving Size Matched Beef n=20 Participants The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Serving Size Matched Soy n=20 Participants The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
Net Incremental Area Under the Curve (niAUC) of Perceived Hunger and Fullness "How strong is your feeling of being full?"	2440 mm*min Standard Error 1360	3320 mm*min Standard Error 1600	2270 mm*min Standard Error 1220	1910 mm*min Standard Error 1560
Net Incremental Area Under the Curve (niAUC) of Perceived Hunger and Fullness "How strong is your feeling of hunger?"	45 mm*min Standard Error 1000	-2840 mm*min Standard Error 1650	-1360 mm*min Standard Error 1410	745 mm*min Standard Error 1480

PRIMARY outcome

The samples were collected in test tubes containing ethylenediaminetetraacetic acid. Protease inhibitors (pefabloc SC and dipeptidyl peptidase) were added to some of the tubes to reduce protein degradation. The plasma was separated and stored at -80°C. Plasma total glucagon-like peptide (GLP-1) and peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling magnetic bead-based multi-analyte, metabolic panel, 2-plex assay and Magpix Luminex technologies. niAUC was calculated throughout the testing period by computing the summation of the average change from baseline score (units of pg/ml) for each time point and the subsequent time point, multiplied by the difference in time (units of min) between the two time instances for a total of 20 blood samples.

Outcome measures

Outcome measures
Measure	Macronutrient and Fiber Matched Beef n=20 Participants The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Macronutrient and Fiber Matched Soy n=20 Participants The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).	Serving Size Matched Beef n=20 Participants The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Serving Size Matched Soy n=20 Participants The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
Net Incremental Area Under the Curve (niAUC) of Plasma Total Glucagon-like Peptide (GLP-1) and Total Peptide YY (PYY) GLP-1	4100 (pg*min)/ml Standard Error 811	2790 (pg*min)/ml Standard Error 1450	2120 (pg*min)/ml Standard Error 916	4870 (pg*min)/ml Standard Error 1200
Net Incremental Area Under the Curve (niAUC) of Plasma Total Glucagon-like Peptide (GLP-1) and Total Peptide YY (PYY) PYY	1590 (pg*min)/ml Standard Error 944	1330 (pg*min)/ml Standard Error 1710	1980 (pg*min)/ml Standard Error 1720	1720 (pg*min)/ml Standard Error 6430

PRIMARY outcome

Timeframe: 3 hours

Participants viewed 3 categories of pictures including food, nonfood (animals), and blurred baseline images. The pictures from each category were presented in blocks of images. Animal pictures were used to control for visual richness and general interest (i.e., appealing but not appetizing). To determine the effects of protein type on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus \[food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing\] and protein source (BEEF vs. SOY) comparisons within the macronutrient and fiber-matched condition and the serving size-matched conditions, separately. The mean percent signal change in the maximum voxel within each region that displayed significant activation after the BEEF and SOY meals was then determined. Talairach coordinates for each region are presented for each row as (x;y;z).

Outcome measures

Outcome measures
Measure	Macronutrient and Fiber Matched Beef n=21 Participants The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Macronutrient and Fiber Matched Soy n=21 Participants The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).	Serving Size Matched Beef The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Serving Size Matched Soy The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
Food Cue-stimulate fMRI Brain Scans Post-Pre lunch Anterior Cingluate (2;25;0)	-22 percent signal change Standard Error 6	7 percent signal change Standard Error 9	—	—
Food Cue-stimulate fMRI Brain Scans Post-Pre lunch Insula (-40;10;-8)	-30 percent signal change Standard Error 6	-7 percent signal change Standard Error 10	—	—

SECONDARY outcome

Population: Four participants were excluded because of insufficient time points.

Plasma amino acid concentrations were measured from the pre and hourly postprandial time points until dinner request following the Macronutrient and Fiber Matched BEEF meal and the Serving Size Matched Beef Meal. An average amino acid concentration was then determined from the change from baseline concentration for all available time points. Plasma amino acid analyses were performed through the University of Missouri-Columbia Agricultural Experiment Station Chemical Laboratories using cation-exchange chromatography (cIEC-HPLC) coupled with post-column ninhydrin derivatization and quantitation.

Outcome measures

Outcome measures
Measure	Macronutrient and Fiber Matched Beef n=17 Participants The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Macronutrient and Fiber Matched Soy n=17 Participants The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).	Serving Size Matched Beef The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).	Serving Size Matched Soy The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
Plasma Amino Acids Leucine	4.68 pg/ml Standard Error 1.06	1.61 pg/ml Standard Error 0.65	—	—
Plasma Amino Acids Histidine	1.41 pg/ml Standard Error 0.44	-0.29 pg/ml Standard Error 0.33	—	—
Plasma Amino Acids Taurine	0.24 pg/ml Standard Error 0.18	-0.78 pg/ml Standard Error 0.25	—	—
Plasma Amino Acids Valine	4.01 pg/ml Standard Error 1.09	0.03 pg/ml Standard Error 0.86	—	—
Plasma Amino Acids Methionine	0.64 pg/ml Standard Error 0.22	0.04 pg/ml Standard Error 0.18	—	—
Plasma Amino Acids Isolecuine	2.51 pg/ml Standard Error 0.60	1.04 pg/ml Standard Error 0.38	—	—
Plasma Amino Acids Tyrosine	1.49 pg/ml Standard Error 0.57	0.12 pg/ml Standard Error 0.35	—	—
Plasma Amino Acids Phenylalanine	0.40 pg/ml Standard Error 0.34	-0.13 pg/ml Standard Error 0.33	—	—
Plasma Amino Acids Tryptophan	4.78 pg/ml Standard Error 0.41	2.65 pg/ml Standard Error 0.51	—	—
Plasma Amino Acids Lysine	5.02 pg/ml Standard Error 1.26	0.33 pg/ml Standard Error 1.07	—	—
Plasma Amino Acids Tryptophan/Large Neutral Amino Acids	0.020 pg/ml Standard Error 0.004	0.019 pg/ml Standard Error 0.005	—	—
Plasma Amino Acids Total Amino Acids	29.13 pg/ml Standard Error 10.90	-6.35 pg/ml Standard Error 8.63	—	—

Adverse Events

Macronutrient and Fiber Matched BEEF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Macronutrient and Fiber Matched SOY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serving Size Matched BEEF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serving Size Matched SOY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Leidy

Purdue University

Phone: 765-496-0184

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place