Whey Supplementation for Quality of Life

Overseen By Kinta Schott, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Corticosteroids, NSAIDs, Anticoagulants, others

Disqualifiers: Smoking, Lactose intolerance, GI disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

5 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You will need to stop taking pre- and probiotics, laxatives or fiber supplements, antacids, and prokinetics starting 1 month before and throughout the study. If you use medications that affect protein metabolism or certain other medications like anti-inflammatories, you may not be eligible to participate.

What data supports the effectiveness of the treatment Multi-ingredient Whey Supplement, Multi-ingredient Fermented Whey Supplement for improving quality of life?

Research shows that whey protein can improve functional capacity and reduce complications in cancer patients, and it may also enhance exercise performance and aid in weight loss while preserving muscle. These benefits suggest potential positive effects on quality of life. ^{1 2 3 4 5}

Is whey supplementation safe for human consumption?

Whey protein supplements, including whey basic protein isolate, are generally considered safe for human consumption at recommended levels. Studies have shown no safety concerns for infants, toddlers, or adults when consumed within the proposed use levels, and the intake of essential metals from whey supplements does not pose a health risk. ^{6 7 8 9 10}

How is the Multi-ingredient Whey Supplement treatment different from other treatments for improving quality of life?

The Multi-ingredient Whey Supplement is unique because it combines whey with probiotics, which are beneficial bacteria that can improve gut health. This combination may offer additional health benefits compared to standard whey supplements by enhancing the balance of good bacteria in the digestive system. ^{7 11 12 13 14}

What is the purpose of this trial?

GI distress is widely prevalent among athletes, ranging from 30 to 90% in recreationally and professionally active athletes. As the recipient of nutrients, the gastrointestinal (GI) tract plays an important role in athleticism. The following pilot project aims to better understand if a fructose load after hiking under heat stress will result in a meaningful hydrogen breath elevation as a marker for malabsorption in healthy participants, and if supplementation of a multi-ingredient fermented whey supplement will result in a different hydrogen breath response rate after a heat stress hiking test.

Eligibility Criteria

This trial is for healthy individuals who often experience gastrointestinal distress, particularly athletes. Participants should be interested in how different carbohydrate feedings affect their digestive system after physical activity in the heat.

Inclusion Criteria

Completed PAR-Q+ without any 'yes' responses

Healthy subjects living in the United States

Written informed consent

Exclusion Criteria

I am not taking steroids, NSAIDs, or acne medications.

Clinical or self-perceived milk protein allergy

I have a musculoskeletal disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Familiarization

Participants undergo familiarization with the exercise protocol, including the Ebbeling Submax Test to determine VO2max.

1 week

1 visit (in-person)

Baseline Testing

Participants complete two baseline exercise tests with carbohydrate feeding, including a 60-minute hiking test followed by hydrogen breath and gastrointestinal symptoms data collection.

2 weeks

2 visits (in-person)

Supplementation and Testing

Participants undergo a 3-week protein supplementation protocol followed by a test visit, then an additional 2-week supplementation protocol and a final test visit.

5 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the supplementation and testing phases.

4 weeks

Treatment Details

Interventions

• Multi-ingredient Whey Supplement

Trial Overview The study is testing whether a multi-ingredient fermented whey supplement can change hydrogen breath levels—a sign of carb malabsorption—after hiking under heat stress compared to just a fructose load.

Participant Groups

Group I: Baseline exercise tests with carbohydrate feeding and after supplementation Experimental Treatment 1 Intervention

This arms includes the assessment for difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve, as well as taking multiple self-reported gastrointestinal symptom ratings during exercise test 1 and 2. In addition, this arm will assess hydrogen breath response and gastrointestinal symptom ratings (using one of the previously determined carbohydrate boluses) after supplementing a multi-ingredient whey protein for 3 weeks, followed by 2 more weeks of supplementation.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Findings from Research

Adding whey or skimmed milk powder to fortified blended foods (FBF) can enhance protein quality and potentially improve health outcomes, such as weight gain and recovery from malnutrition, especially in vulnerable groups like malnourished infants and individuals living with HIV or AIDS.

While the addition of milk proteins may improve flavor and reduce antinutrients, it significantly increases the cost of FBF, making it necessary to target only specific vulnerable populations who would benefit the most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of whey or skimmed milk powder in fortified blended foods for vulnerable groups. Hoppe, C., Andersen, GS., Jacobsen, S., et al.[2023]

Whey protein supplementation significantly reduced postoperative complications in cancer patients, with complications occurring in 22% of those supplemented compared to 32% in the control group, based on a meta-analysis of 10 trials involving 643 patients.

Patients who received whey protein showed improved functional walking capacity both before surgery and four weeks post-surgery, indicating enhanced physical recovery, although there were no significant differences in length of stay or thirty-day readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Whey Protein Supplementation on Perioperative Outcomes in Patients with Cancer-A Systematic Review and Meta-Analysis (PROSPERO 2020: CRD42020188666). Srinivasaraghavan, N., Das, N., Balakrishnan, K., et al.[2022]

In a study involving 40 participants, regular consumption of curd was associated with a 19% improvement in abdominal pain and a 16% improvement in gastrointestinal deposition scores, suggesting better tolerability of curd compared to non-consumption.

Despite no significant changes in body weight or plasma health markers, curd intake within a balanced diet showed potential benefits for subjective gastrointestinal symptoms, likely due to its nutritional composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A regular curd consumption improves gastrointestinal status assessed by a randomized controlled nutritional intervention. Navas-Carretero, S., Abete, I., Cuervo, M., et al.[2015]

Whey protein (WP) supplementation in mice improved exercise performance, as indicated by increased grip strength and slightly enhanced endurance time, after a 6-week aerobic exercise training protocol.

WP supplementation also positively affected body composition and biochemical markers, leading to decreased body and organ weights while increasing levels of beneficial proteins like albumin and total protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey protein improves exercise performance and biochemical profiles in trained mice. Chen, WC., Huang, WC., Chiu, CC., et al.[2021]

In a 12-week study with a reduced calorie diet, participants taking Prolibra lost significantly more body fat (2.81 kg) compared to the control group (1.62 kg), indicating its efficacy in enhancing fat loss.

Prolibra users also preserved more lean muscle mass (1.07 kg loss) compared to the control group (2.41 kg loss), suggesting that it may help maintain muscle while promoting weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study. Frestedt, JL., Zenk, JL., Kuskowski, MA., et al.[2022]

The EFSA Panel concluded that whey basic protein isolate, derived from skimmed cow's milk, is safe for use in infant formula, meal replacements, and dietary supplements, with no safety concerns raised regarding its composition or production process.

The estimated intake levels for infants and toddlers (up to 27.8 mg/kg body weight per day) are considered safe, with sufficient margins of exposure indicating that it does not pose a nutritional disadvantage or genotoxicity risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283. Turck, D., Bresson, JL., Burlingame, B., et al.[2023]

The study successfully produced fermented drinks from liquid whey protein concentrates and ultrafiltrated permeates, which maintained high levels of viable probiotics (over 7 log CFU/mL of lactococci and lactobacilli) after 14 days of refrigeration, meeting safety standards set by the EFSA and FDA.

The physicochemical and sensory properties of the fermented drinks were acceptable, indicating that this method of using whey protein can lead to the development of novel functional foods with potential health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Functional Whey-Based Drinks with Great Potential in the Dairy Industry. Pereira, C., Henriques, M., Gomes, D., et al.[2020]

A systematic review of 16 randomized controlled trials involving healthy adults aged 35 and older found that while whey and colostrum beverages were studied, the evidence for their objective health benefits was inconclusive due to high variability and risk of bias in the studies.

The review highlighted the need for clearer reporting and standardized measures in future research to better support food-health claims and protect consumers from misleading information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Benefits of Whey or Colostrum Supplementation in Adults ≥35 Years; a Systematic Review. Blair, M., Kellow, NJ., Dordevic, AL., et al.[2020]

A study of 47 whey protein supplements revealed that while they provide essential minerals like potassium and calcium, high consumption (up to 100 g/day) could lead to excessive intake of certain metals like chromium and zinc, potentially posing health risks.

Despite the potential for high metal intake, daily consumption of whey protein supplements (30, 60, or 100 g) over 25 years does not appear to pose a significant health risk, as indicated by a hazard index of less than one, suggesting the need for better consumer information and regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey Protein Dietary Supplements: Metal Exposure Assessment and Risk Characterization. Bethencourt-Barbuzano, E., González-Weller, D., Paz-Montelongo, S., et al.[2023]

The EFSA Panel concluded that whey basic protein isolate from skimmed cow's milk is safe for human consumption, including its use in infant formulas and food supplements, based on a review of its safety in 2018.

The Panel determined that extending the use of whey basic protein isolate in infant formulas and food supplements would not increase the potential intake beyond previously assessed levels, confirming its safety at these new proposed uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283. Turck, D., Castenmiller, J., de Henauw, S., et al.[2020]

Fermented dairy beverages containing probiotics Lactobacillus acidophilus and Bifidobacterium lactis showed good potential for probiotic supplementation, with varying concentrations of whey (0-80%) affecting their microbial and chemical properties.

The study indicated that while whey concentration positively influenced the growth of probiotic cultures, there is a limit to its effectiveness, suggesting an optimal range for enhancing the health benefits of these dairy products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short communication: Effects of different whey concentrations on physicochemical characteristics and viable counts of starter bacteria in dairy beverage supplemented with probiotics. Castro, WF., Cruz, AG., Rodrigues, D., et al.[2015]

Probiotic beverages made from fresh acid whey and milk, using either buttermilk or sweet whey powder, effectively support the growth of beneficial bacteria, maintaining levels above 8 log cfu/ml throughout a 21-day storage period.

Beverages with the Lactobacillus acidophilus La-5 strain exhibited higher hardness and acidity, while those with Bifidobacterium animalis Bb-12 had increased acetaldehyde content, indicating that the choice of probiotic strain influences the beverage's sensory and chemical properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented probiotic beverages based on acid whey. Skryplonek, K., Jasińska, M.[2020]

Fermented beverages made from acid whey using probiotic cultures like Lactobacillus acidophilus and Bifidobacterium animalis can maintain high probiotic counts (over 8 log cfu/mL) during 21 days of refrigerated storage, indicating their potential as functional foods.

The sensory properties and acidity of the beverages varied based on the type of milk used and the probiotic culture, with the best sensory qualities found in a beverage made from whey, condensed milk, and Lactobacillus acidophilus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic fermented beverages based on acid whey. Skryplonek, K., Dmytrów, I., Mituniewicz-Małek, A.[2019]

Whey retentate from Bifidobacteria fermented milk positively influenced gut microbiota by promoting the growth of beneficial bifidobacteria and reducing harmful bacteria like Clostridium perfringens, as observed in a simulator of the human intestinal ecosystem over 15 days.

The treatment resulted in increased production of beneficial metabolites like acetic acid while decreasing undesirable ammonium levels, indicating potential health benefits for gut health that should be further explored in live studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The regulatory effects of whey retentate from bifidobacteria fermented milk on the microbiota of the Simulator of the Human Intestinal Microbial Ecosystem (SHIME). Meddah, AT., Yazourh, A., Desmet, I., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of whey or skimmed milk powder in fortified blended foods for vulnerable groups. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Whey Protein Supplementation on Perioperative Outcomes in Patients with Cancer-A Systematic Review and Meta-Analysis (PROSPERO 2020: CRD42020188666). [2022]

3. England pubmed.ncbi.nlm.nih.gov

A regular curd consumption improves gastrointestinal status assessed by a randomized controlled nutritional intervention. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Whey protein improves exercise performance and biochemical profiles in trained mice. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283. [2023]

7. Croatia pubmed.ncbi.nlm.nih.gov

Novel Functional Whey-Based Drinks with Great Potential in the Dairy Industry. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Health Benefits of Whey or Colostrum Supplementation in Adults ≥35 Years; a Systematic Review. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Whey Protein Dietary Supplements: Metal Exposure Assessment and Risk Characterization. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Short communication: Effects of different whey concentrations on physicochemical characteristics and viable counts of starter bacteria in dairy beverage supplemented with probiotics. [2015]

12. Poland pubmed.ncbi.nlm.nih.gov

Fermented probiotic beverages based on acid whey. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Probiotic fermented beverages based on acid whey. [2019]

14. England pubmed.ncbi.nlm.nih.gov

The regulatory effects of whey retentate from bifidobacteria fermented milk on the microbiota of the Simulator of the Human Intestinal Microbial Ecosystem (SHIME). [2019]