An Open-Label, Two-Arm Pilot Study of the Tolerability, Consumer Acceptability, and Exploratory Well-Being Outcomes of a Multi-Ingredient Protein Formula in Two Flavors in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 15
研究概览
简要总结
This is an open-label, two-arm pilot study designed to evaluate the tolerability, consumer acceptability, and well-being outcomes of a multi-ingredient protein formula, available in two flavors (Vanilla Protein Formula and Chocolate Protein Formula), in generally healthy adults aged 21-65 with a BMI of 18.5-34.9 kg/m². Approximately 50 participants will be allocated in a 1:1 ratio, balanced on age and gender, to receive either the vanilla or chocolate formula (approximately 25 participants per arm). Participants will consume one serving (1 scoop, 51 grams) of their assigned product daily for 15 consecutive days, reconstituted in water or a beverage of their choice. The primary outcomes are safety and tolerability, assessed via a Safety and Tolerability Questionnaire, and changes in global health assessed using the Global-10 scale. Secondary outcomes include changes in cognitive function assessed using the PROMIS v2.0 Cognitive Function - Abilities 8a instruments, and consumer acceptability, measured using a 9-point hedonic liking scale. All assessments are self-reported and completed electronically at home.
详细描述
The test product is a multi-ingredient powdered dietary supplement combining fermented yeast protein, grass-fed bovine collagen peptides, creatine monohydrate, and a prebiotic fiber blend, formulated for once-daily consumption as a beverage and available in two flavors: vanilla and chocolate. While the constituent ingredients are individually supported by existing literature, the tolerability, adherence, and consumer acceptability of this specific combination-along with its potential to influence self-reported measures of global health and cognitive function-have not yet been characterized. Establishing this real-world tolerability and acceptability profile across both flavors is a necessary precursor to designing a larger, controlled efficacy trial. This study employs a fully remote, decentralized design. No in-person visits, laboratory testing, or specialized clinical procedures are required. All study assessments will be completed electronically by participants using online questionnaires. Participants will be allocated in a 1:1 ratio to the Vanilla Protein Formula or the Chocolate Protein Formula using systematic allocation stratified by gender and age. Participants will consume one serving (1 scoop) daily for 15 consecutive days. Assessments are completed at baseline (Day 0), Day 7, and Day 15, with an end-of-study follow-up questionnaire 4-7 days after the final dose; brief check-in surveys on Days 1, 3, 7, and 15 capture adherence and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
This is an open-label study; no blinding procedures will be employed. Both participants and the research team will be aware of flavor assignment throughout the study.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 21-65 years, inclusive
- •Generally healthy, as determined by self-reported medical history and investigator judgment
- •Body mass index 18.5-34.9 kg/m² (as operationally verified)
- •Willing and able to consume the test product once daily for 15 days and to complete scheduled questionnaires
- •Can read and write English.
- •Provide voluntary, written, informed consent to participate in the study.
- •Agree to provide a valid cell phone number and are willing to receive communications through text.
- •Willing to complete questionnaires, records, and diaries associated with the study.
- •Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
排除标准
- •Known allergy or intolerance to any study-product component, including yeast-derived protein, bovine collagen, creatine, the prebiotic fiber blend, allulose, or Reb M.
- •Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the trial
- •Clinically significant gastrointestinal disorder that could confound tolerability assessment (e.g., inflammatory bowel disease, symptomatic irritable bowel syndrome, prior major GI surgery), per investigator judgment
- •Known renal impairment or condition for which supplemental creatine is not advised
- •Serious or unstable medical condition, or any condition that in the investigator's judgment would compromise participant safety or data integrity
- •Participation in another interventional study within 30 days prior to enrollment
- •Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
- •Having had a significant cardiovascular event in the past 6 months
- •Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
- •On immunosuppressive therapy
- •Having had surgery within the past 6 weeks or upcoming planned surgery in the next few months
- •Adults lacking capacity to consent
研究组 & 干预措施
Vanilla Protein Formula
Participants receive the Vanilla Protein Formula, a vanilla-flavored, multi-ingredient ready-to-mix powdered dietary supplement. Participants consume one serving (1 scoop, 51 grams) daily for 15 consecutive days, reconstituted in water or a beverage of their choice.
干预措施: Vanilla Protein Formula (Dietary Supplement)
Chocolate Protein Formula
Participants receive the Chocolate Protein Formula, a chocolate-flavored, multi-ingredient ready-to-mix powdered dietary supplement. Participants consume one serving (1 scoop, 51 grams) daily for 15 consecutive days, reconstituted in water or a beverage of their choice.
干预措施: Chocolate Protein Formula (Dietary Supplement)
结局指标
主要结局
Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 15
时间窗: Baseline to Day 15
Safety and tolerability of daily use of the protein formula. Each symptom item (increased anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, sexual dysfunction) is rated 1 (not at all) to 5 (a great deal); higher score = worsening of symptoms.
Change from baseline in PROMIS Global Health (Global-10) T-scores at Day 15
时间窗: Baseline to Day 15
PROMIS Global Health v1.2 (10 items) yields Global Physical Health (GPH) and Global Mental Health (GMH) T-scores (mean 50, SD 10 in the reference population); higher T-scores = better health. Pooled across both flavor arms.
次要结局
- Overall product liking on the 9-point hedonic scale at Day 15, by flavor arm(Day 15)
- Change from baseline in PROMIS v2.0 Cognitive Function - Abilities Short Form 8a T-score at Day 15(Baseline to Day 15)
- Change from baseline in Safety and Tolerability Questionnaire symptom scores at Day 7(Baseline to Day 7)