An Investigation Into the Effects of a Wild Blueberry Powder and a Wild Blueberry Extract on Cognition in Older Adults

University of Reading

Status: Completed

Conditions: Cognitive Decline

Treatments: Dietary Supplement: Wild Blueberry extract 100mg; Dietary Supplement: Wild Blueberry Powder - 900 mg; Dietary Supplement: Wild Blueberry Powder - 450mg; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02446314

RDG-001

Details and patient eligibility

About

The purpose of this study is to determine whether a 6 month dietary intervention with wild blueberry powder and extract stabilised with L-cysteine and L-glutathione have an effect on cognitive performance in participants aged between 65 - 80.

Full description

Interventions: A placebo and two different wild blueberry products will be used in this study (see Table 1). A wild blueberry powder at two different doses and a single wild blueberry extract. The wild blueberry powder will be used at a 450 mg-dose, to which 45 mg of L-Cysteine and 5 mg of L-Glutathione will be added (wild blueberry powder-450), as well as at a 900 mg-dose, to which 90 mg of L-Cysteine and 10 mg of L-Glutathione will also be added (wild blueberry powder-900). The wild blueberry extract will consist of 100 mg of wild blueberry extract supplemented with 10 mg of L-Cysteine and 1 mg of L-Glutathione. Participants will be asked to consume two capsules daily with their normal breakfast. The capsules will be packed in blister packs with 4 capsules per blister. Each box contains 4 blisters (or a total of 16 capsules) in order to provide for 1 week of study medication, with 2 capsules remaining. Participants will be instructed to return the left-over investigational product weekly (i.e two capsules) using stamped addressed envelopes supplied by the experimenters. Weekly assessment of left-over investigational product will allow for continued compliance verification.

Procedure: The study comprises of a telephone screen and then six visits, including a familiarization visit (week T-1), three test visits (week 0, 12 and 24), and two control visits (week 6 and 18). Participants may stop the study treatment without stating any reason at any time during the study. In addition, a participant will be withdrawn from the study if: a subject requests discontinuation, he/she exhibits a serious adverse event to any component of the test product, the participant significantly violates the inclusion or exclusion criteria, an intercurrent illness emerges and/or the investigator's opinion is that withdrawal is appropriate and in the best interest of the participant. If a participant withdraws from the study, he/she will be encouraged to make a final visit as soon as possible, irrespective of the reason for withdrawal, to complete a final battery of cognitive tasks.

1. Screening: once a participant has indicated that they wish to join the trial they will be contacted by telephone for a brief screening session. The research associate (RA) will give a brief overview of the study and will ascertain that each interested volunteer is willing to participate for the entire duration of the study and to check that they fulfill our inclusion/exclusion criteria. Once confirmation of suitability for the study is confirmed, the RA will schedule their familiarization visit.
2. Familiarization Visit: Volunteers will be asked to attend the Nutritional Psychology Unit at the University of Reading where they will receive a detailed explanation on the study by the participating research associate and will be asked to sign the informed consent form before any study procedure starts. A log will be kept identifying all participants having signed the informed consent form (ICF) and the participant will be allocated a participant number. Once consent has been given, the inclusion/exclusion criteria will be checked once again and vital signs (blood pressure and heart rate) and anthropometric measurements (height, weight, BMI) will be taken. The participants will then be asked to complete a number of questionnaires and cognitive tasks comprising: (i) Yale Physical Activity Questionnaire; (ii) Frequency of Forgetting Questionnaire to give a baseline assessment of their memory performance; and (iii) Computerized Global Cognitive Health Assessments (NART, CERAD, MMSE, letter and category fluency; unless as a member of the Older Adult Panel these data have been collected from them in the preceding 3 months). Finally, participants will be given training on the cognitive test battery (tasks outlined below) that will be used during the study to reduce the chances of 'practice' adversely effecting performance on subsequent test days. Before leaving the laboratory, participants will be asked to keep a 72 hour food diary (consisting of 2 week days & 1 weekend day) so that background flavonoid intakes can be measured prior to the start of the intervention.
3. Test Visits (Weeks 0, 12 and 24): All of these sessions will be held in the morning (typically 8am-10am arrival time to suit participants individual needs). Participants will attend the laboratory in a fasted state and on arrival at the laboratory we will check participants still fulfill our inclusion/exclusion criteria, their general well-being, notification of any adverse events, any issues with compliance, and to check whether there have been changes to any concomitant medication. Blood pressure and heart rate will also be measured, and the food diary will be collected (week 0 and 24 only). They will then receive a standard low-flavonoid breakfast and will complete the battery of cognitive tasks (see below). Subjects will then be given their intervention (sufficient quantity until their next test session, in blister packs, weeks 0 and 12 only), and will then be requested to consume 2 capsules each day. At week 24 only, the Yale Physical Activity and Frequency of Forgetting questionnaires will also be administered, and weight will be measured.
4. Control Visits (weeks 6 & 18): These sessions can take place at any time of day to suit the participant. Participants will attend the laboratory at the University of Reading to collect the next 6 week supply of their intervention. During these visits we will check that participants still fulfill our inclusion/exclusion criteria, informally check their well-being, inquire whether there have been any adverse events, and confirm that there have not been any changes to their concomitant medication. At week 18 only participants will be given another copy of the 72 hour food diary (consisting of 2 week days & 1 weekend day and asked to complete this before they return for their test visit in week 24.

Enrollment: 122 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overall healthy volunteers as proven by medical history and/or physical examination and of all ethnicity and socioeconomic status
• Free-living
• Subjects with subjective memory complaints
• MMSE: 24-30
• Subjects are willing to maintain their normal eating habits and exercise habits to avoid changes in body weight over the duration of the study
• Being willing to complete the food diaries and questionnaires
• Able to give signed written informed consent
• Signed informed consent form

Exclusion criteria

• Use of complementary and alternative medicine
• History of metabolic disorder, diabetes, substance abuse
• Subjects diagnosed with psychiatric or neurological conditions
• Subjects using medications that might affect the outcome measures (such as antidepressant and sleeping medication), or planned changes

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

122 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen

Treatment:

Dietary Supplement: Placebo

Wild Blueberry Powder - 450mg

Experimental group

Description:

Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen

Treatment:

Dietary Supplement: Wild Blueberry Powder - 450mg

Wild Blueberry Powder - 900 mg

Experimental group

Description:

Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen

Treatment:

Dietary Supplement: Wild Blueberry Powder - 900 mg

Wild Blueberry extract 100mg

Experimental group

Description:

Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen

Treatment:

Dietary Supplement: Wild Blueberry extract 100mg