Cognitive health and sleep in the context of natural aging.
Conditions
Interventions
Group 1: 0.8 g bioactive collagen peptides, 1-week supplementation
Group 2: 5 g bioactive collagen peptides, 1-week supplementation
Group 3: silicon dioxide (placebo), 1-week supplementation
Sponsors
Collagen Research Institute
Eligibility
Sex/Gender
All
Age
55 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Indication of difficulty in sleeping (e.g. Athens Insomnia Scale (AIS) score =6 =15) - Mini Mental State Examination (MMSE) score = 24 - Patient Health Questionnaire-9 (PHQ-9) score = 9 - BMI <35 kg/m2 - Able and willing to give written informed consent - Willing to maintain their habitual diet and exercise routines - Willing to maintain consistent bedtime the evening before study visits - If applicable, stable intake of chronic medication of at least 4 weeks not interfering with the study (e.g. L-Thyroxin, antihypertensives, etc.)
Exclusion criteria
Exclusion criteria: main exclusion criteria - Current or past diagnosis of a major cognitive disorder (e.g. Alzheimer’s Disease or Parkinson’s Disease) or confirmation of a mini stroke (TIA) within the last 3 months - Diabetes mellitus (type I and type II) - Uncontrolled hypertension (SBP > 160mmHg and/or DBP >100mmHg) - A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure - Presence (or past history of) significant psychiatric disorders (severe anxiety, major depression, panic disorder, OCD, PTSD etc.). - History of head trauma, neurological deficits - Presence of significant kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease or any condition which contraindicates, in the investigator’s judgement, entry to the study - Chronic use of any antidepressant drugs in the last 24 months - Use of sedatives or sleeping pills within 3 months prior to study start or during study - Other regular intake of drugs or supplements possibly interfering with this study (e.g. opiates, systemic glucocorticoids, anti-histaminica, neuroleptica, etc.) within 3 months prior to study start or during study - Regular use of supplements (incl. vitamins and minerals) with known cognitive enhancing effects (e.g. ginseng, ginkgo, etc.). A stable dose of vitamin D for at least 3 months will be allowed. - Regular use of collagen products (e.g. hydrolysates, gelatine, etc.) within the last 4 weeks - Smokers (> 5 cigarettes per week) or participants who use vape products - Consumption of caffeinated drinks > 3/day (>300 mg caffeine/day). - Day-nights shift workers - Blood donation within 1 month prior to study start or during study - Consumption of more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females - Inability to complete or understand the cognitive function tests - Red-green color blindness - Relevant allergy or known hypersensitivity against compounds of the study products - Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study - Participants considered inappropriate for the study by investigators, including participants who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of different cognitive domains using a cognitive test battery; time points: at the end of the supplementation phase (pre, 1 hour after and 2 hours after study product intake) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mood / mental fatigue after cognitive testing; determination via visual analog scale (VAS); time points: at the end of the supplementation phase (pre, 1 hour after and 2 hours after study product intake). - Sleep; determination via questionnaires (questionnaire to evaluate sleep in the previous night (SF-A/R)), questionnaire to evaluate sleep (Athens Insomnia Scale (AIS) for Non-Clinical Application)); time points: after one week of supplementation. - Mental well-being; determination via questionnaires (Well-Being Index (WHO-5)), questionnaire on current condition (ASTS)); time points: after one week of supplementation. - Glucose in the blood; time points: at the end of the supplementation phase (pre, 1 hour after and 2 hours after study product intake). - Brain-derived neurotrophic factor (BDNF) in the blood (optional); time points: at the end of the supplementation phase (pre, 1 hour after and 2 hours after study product intake). | — |
Countries
Germany
Contacts
Public ContactDaniel Menzel
BioTeSys GmbH
Outcome results
None listed