EAL

EE: Ephedra (2005)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

Realizing that the pharmacokinetic profile of 7-oxo-DHEA is similar to that of adrenal steroid DHEA, the purpose of the present study was to assess the effects of a formula containing 7-oxo-DHEA combined with 7 other ingredients thought to have a synergistic effect on 7-oxo-DHEA in a similar population of middle-aged overweight adults.
To investigate the effect of an isolated increase in T3 (serum triodothyronine) levels on basal metabolic rate with the use of this supplement.

Definitions

Steady state: Not defined.

Inclusion Criteria:

Understand and give written consent.

Exclusion Criteria:

Refusal to consent
Not meeting inclusion criteria
Diseases in subjects that were excluded: Hepatic or renal disease, diabetes, cardiovascular disease, uncontrolled hypertension, cancer, human immunodeficiency virus infection, AIDS, Cushing’s disease, Addison’s disease, thyroid disease, or seizure disorder, pregnant or lactating;
Medications excluded: Weight loss medications.

Description of Study Protocol:

Randomized to receive 1 capsule (200 mg) of 7-keto naturalean twice/day (n=18) or a placebo (maltodexrin) twice per day (n=17) for 8 weeks.
7-keto-naturalean containes 7-oxo-DHEA 100 mg, L-tyrosine 100 mg, asparagus root extract 100 mg, choline bitartrate 50 mg, inositol 50 mg, copper gluconate 500 pg, manganes 500 micrograms, and potassium iodide 10 micrograms.
Pts were interviewed by a dietitian every 2 weeks either by telephone or clinic visit.

ANTHROPOMETRIC

Baseline, week 4 and week 8 measurements were taken.
Ht measured? Not specified
Wt measured? Yes, Tanita digital scale
Fat-free mass measured? Bioelectric impedance analysis
Prescribed an aerobic exercise program and strength training for 45 min 3 times/week for 8 weeks.

CLINICAL

Monitored heart rate? Yes
Body temperature? Yes
Also measured thyroid panel: Thyroxine T4, total T4, and thyroid-stiulating hormone was obtained at baseline and week 8.

Resting energy expenditure

IC type: Deltatrac II
Equipment of Calibration: Not specified
Coefficient of variation using std gases: No
Rest before measure (state length of time rested if available): Not specified
Measurement length: Not specified
Steady state: Not specified
Fasting length: Not specified
Exercise restrictions XX hr prior to test? Not specified
Room temp: Not specified
No. of measures within the measurement period: Not specified
Were some measures eliminated? Not specified
Were a set of measurements averaged? Not specified
Coefficient of variation in subjects measures? Not specified
Training of measurer? Not specified
Subject training of measuring process? Not specified.

DIETARY

24-hour recall was performed
Prescribed wt loss diet at 25 kcal/kg of desirable body weight.

Data Collection Summary:

Outcome(s) and other measures

Measured REE [(VO₂, l/min), VCO₂ (l/min; ml/kg/min), RQ, ventilation (l/min)].
Thyroid panel
Independent variables of weight, height, age, BMI,and fat-free mass, fat mass.

Blinding used: Yes.

Description of Actual Data Sample:

N=aged 40-69 y
Mean BMI=33.1 kg/m2 (Range: 27.0-42.7)
Range: N=12 males; N=23 females
2 patients (1 in 7-keto-naturalean group and 1 in placebo group) dropped out after 5 weeks; Excluded from the analysis.

Statistical tests

Mann-Whitney Test; There were no missing data for patients completing the study; Normality testing (Lilliefors test) indicated body wt and BMI in both groups were not normally distributed; therefore, nonparametric comparison methods were used.

Summary of Results:

ANTHROPOMETRIC

7-keto- Naturalean (n=18; 7 M; 11 F) Group	Mean±SD
Age, y	49.0±7.3
Wt, kg	97.0±16.3
Ht, cm	not specified
BMI	33.1±4.1
Body fat, %	38.8±11.6
BMR, kcal/d	1680.8 kcal ±257.1

Placebo Group (n=17; 5 M; 12 F) Group	Mean±SD
Age, y	48.5±7.5
Wt, kg	97.0±16.3
Ht, cm	not specified
BMI	33.0±3.8
Body fat, %	38.8±11.6
BMR, kcal/d 9	1705.7 kcal ±279.

RESULTS

Weight loss
Weight loss in the 7-keto-naturalean group differed significantly from the placebo group from baseline to 8 weeks (P=0.038). In the 7-keto-naturalean group, mean weight loss was 2.15±2.98 kg and in the placebo group mean weight loss was 0.72±2.12 kg. BMI decreased by 0.71±0.79 kg/m2 and was statistically significant (P=0.036) compared to placebo group (0.01±1.05 kg/m2).

Body composition and basal metabolic rate
There were no significant between-group difference in changes in body fat, BMR, or fat-free mass (P= 0.41, 0.86, and 0.39, respectively). Changes in basal metabolic rate BMR) was 3.5 kcal/d ±158.3 in the 7-keto-naturalean group and 1.87 kcal/d ±185.5. Intracellular water and extra-cellular water, as measured by BIA, were also not significantly different between groups.

Safety and tolerability
There were no significant between-group difference in vital signs (blood pressure, pulse rate, and temperature). The 7-keto-naturalean group reported 2 adverse events: (i.e., metallic taste and heart burn). No serious adverse events were reported. Laboratory assessment of thyroid function revealed no differences between treatment groups.

Author Conclusion:

As stated by the author in body of report:

“In our study, 7-keto-naturalean combined with a reduced-calorie diet and moderate exercise resulted in a significant change in body weight and BMI after 8 weeks.”
“The results of our study are promising as they reveal a mean weight loss of 2.15 kg or 2.2% from baseline in the 7-keto- Naturalean group.”
“The North American Association for the study of Obesity guidelines for drug treatment of obesity state that a 5% weight loss over a period of 6-12 months is an indicator of success, as this is associated with significant health benefits.”
“One limitation of our study is not studying long-term and therefore, “further long-term weight loss studies are warranted to validate the study conclusions.”

Funding Source:

Industry:

Enzymatic Therapy, Humanetics Corp.

Food Company:

Reviewer Comments:

Strengths

“Strengths include clearly-defined exclusion criteria, discussed drop-outs; and monitored temperature.”

Generalizability/Weaknesses

“There are inadequate or missing descriptions of how IC measurements and height were taken”
"Study biases include:

Do not report tools used to measure compliance with physical activity program; Also study was funded my manufacturer of 7-keto-naturalean supplement
An intervening variable not measured or unclear include how they obtained their 35 overweight and obese patients(I.e., MD referral bias?) and history of weight loss cycling
These are important variables on REE measurement accuracy: all of the IC information in the far left column; and, did not adjust for fat-free mass.”

Generalizability limited to short-term weight loss with bi-weekly dietitian intervention, aerobic & strength training and dietary supplement; Reliability of applying to ethnic and cultural groups are unknown.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	N/A
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	N/A
	1.3.	Were the target population and setting specified?	N/A
2.	Was the selection of study subjects/patients free from bias?		No
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	N/A
	2.2.	Were criteria applied equally to all study groups?	N/A
	2.3.	Were health, demographics, and other characteristics of subjects described?	N/A
	2.4.	Were the subjects/patients a representative sample of the relevant population?	N/A
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		No
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	N/A
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	N/A
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		No
	7.1.	Were primary and secondary endpoints described and relevant to the question?	N/A
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	N/A
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	N/A
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	N/A
	7.5.	Was the measurement of effect at an appropriate level of precision?	N/A
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	N/A
	7.7.	Were the measurements conducted consistently across groups?	N/A
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	N/A
	8.2.	Were correct statistical tests used and assumptions of test not violated?	N/A
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	N/A
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	N/A
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	9.1.	Is there a discussion of findings?	N/A
	9.2.	Are biases and study limitations identified and discussed?	N/A
10.	Is bias due to study's funding or sponsorship unlikely?		No
	10.1.	Were sources of funding and investigators' affiliations described?	N/A
	10.2.	Was the study free from apparent conflict of interest?	N/A