Trial | NCT01942746  Report issue

Title

Blueberry Effects on Dark Vision and Glare Recovery
Placebo-controlled Cross-over Studies Examining Blueberries Effects on Dark Vision and Recovery After Photo-bleaching

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    blueberry allergenic extract ...

  • Study Participants

    72
Clinical evidence for effects of plant anthocyanins on vision, and particularly night vision is controversial. Two clinical trials were conducted to investigate whether blueberry juice consumption affected visual dark adaptation, functional night vision, and recovery after photo-bleaching of the retina. One trial (S2) employed a 3 week intervention and washout period, and two doses of blueberries plus a placebo. The other trial (L1) employed a 12 week intervention plus an 8 week washout and tested one blueberry juice dose against a juice placebo.
Vision Tests: 1. Dark adaptometry, 2. scotopic visual acuity, 3. scotopic contrast sensitivity, 4. rod/cone conversion, 5. recovery after retinal photobleaching
Study Started
Jul 31
2005
Primary Completion
Jul 31
2006
Study Completion
Jul 31
2006
Last Update
Sep 16
2013
Estimate

Dietary Supplement Blueberry Juice S2

Blueberry Juice S2 was commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars. Colorimetric analysis showed that S2 juice contained 6.04 (SD=0.20) mg anthocyanins (C3G) eq/g dry mass.

  • Other names: Single-strength blueberry juice, commercially prepared

Dietary Supplement Blueberry Capsules S2

Commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars was freeze dried then powdered and encapsulated in gelatin capsules. Colorimetric analysis indicated an anthocyanin concentration in the powder of 2.37(SD=0.18) mg C3G eq per capsule.

  • Other names: freeze-dried blueberry juice powder

Dietary Supplement Placebo Capsule S2

Placebo Capsule S2 (containing no anthocyanins) were prepared by freeze drying red beets and grinding them to fine powder before encapsulating in gelatine capsules. Red beets do not contain anthocyanins.

  • Other names: Red beet powder

Dietary Supplement Placebo Juice L1

Placebo juice was prepared from water, sugars, citric acid, sodium citrate, and artificial colors and flavours, then pasteurized. The placebo juice contains no anthocyanins.

Dietary Supplement Blueberry Juice L1

Blueberry Juice L1 was commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars. Colorimetric analysis showed that L1 juice contained 6.83 (SD=0.20) mg cyanidin-3-glucoside equivalents (C3GE)/g dry mass at the start of the study, declining to 5.52 (SD=0.09) mg C3GE/g dry mass after 3 months refrigerated storage.

  • Other names: single strength blueberry juice, commercially prepared

Blueberry Juice Active Comparator

Commercially prepared single strength blueberry juice which was composed of a 50:50 blend of two highbush blueberry species (Vaccinium corymbosum L. 'Rubel' and V. ashei Reade 'TifBlue'). Volunteers consumed 300 mls of juice/day (247-271 mg anthocyanins (as C3G) daily) while on this intervention, for either 3 weeks (Blueberry Juice S2) or 12 weeks (Blueberry Juice L1).

Blueberry Capsules Active Comparator

Commercially prepared single strength blueberry juice which was composed of a 50:50 blend of two highbush blueberry species (Vaccinium corymbosum L. 'Rubel' and V. ashei Reade 'TifBlue')was freeze dried to a powder and encapsulated in gelatin capsules (Blueberry Capsules S2). Volunteers consumed 3 capsules/daily (7.11mg anthocyanin (as C3G eq) for 3 weeks.

Placebo Placebo Comparator

Volunteers consumed in S2 three placebo capsules daily for 3 weeks. In L1 volunteers consumed 300ml placebo juice for twelve weeks. Placebo products contained no anthocyanins.

Washout (S2 and L1) No Intervention

Washout periods involved no study products. Washout was 3 weeks in S2 and or 8 weeks (L1) in duration.

Criteria 

Inclusion Criteria:

visual acuity better than 6/7.5 on EDTRS acuity chart at 2.5m
visual contrast sensitivity within normal range at 2.5m as tested on Visteck 3000
stereo acuity better than 80 seconds of arc on Frisby stereoacuity test
no ocular history other than refractive glasses
no family history of eye disease

Exclusion Criteria:

family history of retinal degeneration, glaucoma, diabetes, hypertension, cataract, or amblyopia (dimness in vision).
evidence in subject (upon examination) of amblyopia (dimness in vision), manifest strabismus (unable to focus both eyes on one spot), or anisotropia (non-uniform responsiveness between both eyes).
intraocular pressure above 21mmHG from an average of three measures using Mentor tonopen-XL
No Results Posted