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After Baby Boost™ - Trial Abstract

Introduction

• Prospective, randomized, double-blind, placebo-based, parallel-group clinical trial
• This trial had IRB approval from Fox Commercial IRB, Candice Woods, Exec. Director, Springfield, IL
• Randomization determined who was on placebo and who started with the active product; randomization was equal
• The duration was for a minimum of two months and a maximum of seven months on either product or placebo
• All subject contact was with a study coordinator, nurse practitioner or research nurse who was blinded to the randomization scheme
• Subjects were paid $100 for completion of their participation in this trial
• Subjects were recruited from the general population of Bangor, Maine; the major exclusion criteria were women with menopause due to surgery or taking hormone replacement therapy

Methods:

Women who recently had delivered a normal baby, who both were in apparent good health, were recruited for this three-month trial. Mothers needed to be between 18 and 40 inclusive, able to tolerate either product or placebo, and signed an approved informed consent form.  Exclusions included mothers with moderately severe conditions, such as chronic arthritis, irritable bowel disease, cardiac, and others, or those with a history of alcohol or substance abuse.

Product Usage:   Four capsules of the vitamin nutrient formula and two gel capsules of the essential oils were taken in the morning with food and water.  At nighttime just before bedtime, subjects were instructed to take one scoopful of the nighttime sleep formula with water.  Placebo products were developed to look and appear like the actual product.

The primary end-points are divided between physical and emotional parameters.  The specific parameters for both categories are listed below.

 

Secondary end-points include ‘recommend product’ and ‘quality-of-life’.

We created several summary variables consisting of groups of the primary end-points.  This approach is often used in medical research and allows for a global comparison involving the entire scope of outcomes.  This summary variable was compared, as were the other variables.

The categories for the summary variable are as follows:

• No Improvement
• Some Improvement: One to twenty point improvement
• Moderate Improvement: Twenty-one to forty point improvement
• Significant Improvement: Forty-one to sixty or more point improvement
• Dramatic Improvement: Sixty-one or more points

• Each questions is rated from 0 to 3, where 0 is the absence of this emotion, while 3 represents a great deal of problems in this area.
• The 16 questions were averaged for each subject
  

Results

Fifty subjects were consented and randomized. Thirty-six women completed the trial, nineteen from the product group, and seventeen from the placebo arm.  The final numbers for the various end-points, varied, since not all subjects experienced each different symptom at baseline.  For example, a subject may have reported on depression, fatigue, insomnia, or mood swings, but not headaches. 

Baseline Characteristics

There were few differences with respect to the many baseline characteristics.  These indicators includes demographics, medical and behavioral risks, education, jobs, income, and family parameters. 

None of the major demographics or potential risk factors, such as age, diabetes, hypertension, thyroid disease, major surgery, weight and others were clinically or statistically different.  The placebo group had a slightly higher number of subjects who have elevated cholesterol levels while the product group had slightly higher rates for caffeine, surgery, weight, and risk profile (both mean and percent of high risk).  These differences are very small and reflect the young, healthy status of this population and the success of the randomization process.

Baseline Characteristics and Risk Score

Parameter	Placebo (%) Unless Specified	Product (%) Unless Specified	P Value
Age (MEAN)	25.9	26.8	0.60
Alcohol (3 or more weekly)	5.9	10.5	N.S.
Body Mass Index (BMI) (MEAN)	29.1	30.2	0.65
Caffeine (3 or more cups)	5.9	15.8	0.61
Caffeine (MEAN)	1.10	1.39	0.50
Cancer (hx. or current)	0	0	N.S.
Cardiac	0	0	N.S.
Cholesterol (elevated)	11.8	0	0.22
COPD	11.8	5.3	0.59
Diabetics	5.9	0	N.S.
Gastrointestinal	0	0	N.S.
Hypertension	5.9	0	N.S.
Income *	1.02	1.12	0.63
Injury (serious)	0	5.3	N.S.
Liver	0	0	N.S.
Osteoporosis	0	0	N.S.
Renal Ds.	0	0	N.S.
Surgery	35.3	57.9	0.36
Thyroid Ds.	5.9	5.2	N.S.
Weight (MEAN)	175.1	187.8	0.40
Risk (MEAN)**	0.94	1.16	0.48
High Risk	0	10.5	0.49

* Originally listed as a category, then adjusted for Number of Adults
N.S. = Not Significant
Fisher’s Exact Two-Tail was used when appropriate for small cell sizes

Age Distribution

Age	Placebo (%)	Product (%)
18-19	11.8	0
20-21	17.6	10.5
22-23	11.8	10.5
24-25	5.9	26.3
26-27	11.8	15.8
28-29	11.8	5.3
30-31	11.8	10.5
32-33	17.6	5.3
34-35	0	15.8

Difference of Means for the Highest Level of Differences

Parameter	Placebo	Product	P Value
Concentration	0.88	3.0	0.012
Cramping	0.29	1.47	0.045
Depression	1.12	2.21	0.09
Dizziness	0.71	1.22	0.38
Fatigue	2.71	5.26	0.013
Fluid Retention	-0.25	1.83	0.02
Headaches	1.29	2.21	0.27
Insomnia	1.76	2.63	0.32
Irritability	2.12	3.63	0.03
Joint Aches	-0.12	1.53	0.009
Mood Swings	2.06	3.32	0.10
Nervousness	1.35	1.74	0.50
Sweating	1.47	2.95	0.06
Temperature Swings	0.50	0.79	0.53
Tender Breasts	0.24	1.38	0.08
Vaginal Dryness	0.59	1.50	0.22
Summary Variable No. 1	16.7	36.5	0.001
Summary Variable No. 2	0.27	0.45	0.09

Percent Improvement
Cumulative Percent

	Treatment	2+ (%)	3+ (%)	4+ (%)	5+ (%)
Concentration	Placebo	29.4	11.8	11.8	5.9
	Product	68.4	47.4	36.8	31.6
Cramping	Placebo	17.6	0	0	0
	Product	36.8	26.3	10.5	5.3
Depression	Placebo	29.4	11.8	5.9	5.9
	Product	63.2	42.1	10.5	5.3
Dizziness	Placebo	23.5	11.8	5.9	0
	Product	22.2	22.2	16.7	11.1
Fatigue	Placebo	58.8	35.3	29.4	29.4
	Product	94.7	78.9	73.7	57.9
Fluid Retention	Placebo	12.5	0	0	0
	Product	33.3	33.3	22.2	16.7
Headaches	Placebo	47.1	23.5	17.6	17.6
	Product	52.6	31.6	21.1	15.8
Insomnia	Placebo	41.2	29.4	29.4	11.8
	Product	57.9	47.4	47.4	31.6
Irritability	Placebo	52.9	35.3	17.6	17.6
	Product	89.5	68.4	57.9	21.1
Joint Aches	Placebo	0	0	0	0
	Product	35.3	29.4	23.5	23.5
Mood Swings	Placebo	52.9	29.4	29.4	23.5
	Product	84.2	57.9	47.4	21.1
Nervousness	Placebo	41.2	23.5	11.8	5.9
	Product	63.2	36.8	10.5	0
Sweats	Placebo	23.5	17.6	17.6	17.6
	Product	78.9	63.2	42.1	26.3
Tender Breasts	Placebo	23.5	0	0	0
	Product	37.5	25	12.5	6.3

Summary Variable 1: Cumulative Percents

		“Some” 1-20 Points	“Moderate” 21-40 Points	“Significant” 41-60 Points	“Dramatic” 61 Points or More
Summary	Placebo	82%	41%	6%	0%
	Product	100%	79%	42%	11%

Recommendations

Of those on product, only 16 subjects responded.  Seven or 44% said they would highly recommend this product, while an additional 5 (31%) merely ‘recommended’ it, while 4 (25%) did not recommend this product.  A moderate number of subjects from both groups complained that the nighttime powder was difficult to take (mixing, nightly regimen) and unpleasant to drink.  Several subjects continued in the trial without using this formula on a regular basis.

Adverse Events

There were no serious adverse events in this trial.  There were three subjects (one product, two placebo) who reported headaches (n=2) or minor gastrointestinal upsets (n=1), which abated after stopping the product. 
Heart rates (pulse), systolic and diastolic blood pressures remained clinically unchanged throughout the study in both groups.  This supports the concept that the product (and placebo) did not affect these crucial measurements despite providing effective relief of the major end-points.

Conclusions

Clearly, After Baby Boost is effective in relieving a number of common symptoms associated with typical post partum symptoms.  The group that met the 0.05 criteria included relief in fatigue, fluid retention, irritability, and joint aches. The indicators that met the 0.10 criteria included depression, mood swings, sweating, and tender breasts.  The first summary variable was statistically different while the second summary variable met the 0.10 criteria.

Based on this trial, it appears that After Baby Boost is effective in relieving post partum symptoms, and improves ones’ ability to function normally.  Based on this study, this product appears to be safe, in women who are still nursing and those who never began nursing.

We recommend that the nighttime formula be reformulated into a capsule or tablet for ease-of-use.

• Product Quality Assurance

Appendix:

Multi-Nutrient Formula*

Serving per container: 30
Serving size: 4 capsules in the morning with food.	Per Serving	%DV	%DV Lactating 1st 6 months	%DV Lactating 2nd 6 months
Vitamin A (5019 IU acetate, 1856 IU beta carotene)	6875 IU	137%	84.6%	84.6%
Vitamin C (calcium ascorbate)	1000mg	1667%	1052.6%	1111.3%
Vitamin D 3 (cholecalciterol)	200 IU	50%	50%	50%
Vitamin E (10% mixed tocopherols, 90% d-alpha tocopherol)	220 IU	733%	644.2%	702.7%
Vitamin K1	100mcg	100%	*	*
Thiamine HCI, (B1)	66mg	4400%	4125%	4125%
Riboflavin (B2)	10mg	588%	522.7%	522.7%
Niacin (as nicinamide B3)	33mg	165%	140.3%	140.3%
Vitamin B6 (50% pyridoxal 5 phosphate, 50% pyridoxine HCI)	66mg	3300%	3457%	3457%
Folate (folic acid)	800mcg	200%	285.7%	285.7%
Vitamin (B12)	100mcg	1667%	1746.4%	1746.4%
Biotin	300mcg	100%	*	*
Pantothenic Acid, (B5)	66mg	660%	*	*
Iron (Citrate)	10mg	56%	112%	112%
Zinc (picolinate)	20mg	133%	70%	70%
Selenium (methionate)	30mcg	43%	*	*
Manganese (chelate)	2mg	100%	*	*
Chromium (polynicotinate)	200mcg	166%	*	*
Molybdenum (glycinate)	50mcg	66%	*	*
Potassium (citrate)	90mg	2%	*	*
Choline (bi-tartrate)	200mg	*	*	*
Co-enzyme Q10	30mg	*	*	*
Alpha Lipoic Acid	33mg	*	*	*
Boron (citrate/aspartate)	3mg	*	*	*
Citrus BioFlavinoids	200mg	*	*	*
Inositol	200mg	*	*	*
Rutin	66mg	*	*	*
*Daily Value (DV) Not Established
Other Ingredients: Gelatin capsule, rice flour, vegetable magnesium sterate.

Essential Oils

Servings Per Container: 30
Serving size: Take 2 gel-caps in the morning with food.	Per Serving	%DV*
Calories (energy)	30	3%
Calories from fat	30	3%
Total Fat	3g	**
Cholesterol	<3%	**
Total Omega-3 fatty Acids	1020mg	**
EPA (Eicosapentaenoic Acid)	480mg	**
DHA (Docosahexaenoic Acid)	3600mg	**
Other Omega -3 Fatty Acids	150mg	**
Proprietary Blend	4.5mg
Rosemary Extract (Rosemarinus Osticinalis)		**
Vitamin C (ascorbyl palmitate)		**
Vitamin E (natural tocopherols)		**
*Percent Daily Values based on 2000 calorie diet. **Daily Values (DV) Not Established
Other Ingredients:Omega-3 fish oil, gel capsule (gelatin, glycerin, purified water), natural lemon flavor.

Nighttime Formula*

Servings per container: 30
Serving size: 4 capsules at bedtime.	Per Serving	%DV
Magnesium as Citrate	400mg	100%
Calcium as Citrate	400mg	33%

A portion of Sound Formulas proceeds are donated to Remote Area Medical, USA, a non-profit organization which provides free health care to under-served and disadvantaged populations in America.

 

 

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*These statements have not been evaluated by the FDA.This product is not intended to diagnose, treat, cure or prevent any disease. Consult your physician before using this or any other dietary supplement.