Amberen and Weight Loss: Uncovering the Truth Behind the Claims

The physiological changes associated with the onset of menopause can significantly decrease the quality of life for many women. While hormone therapy (HT) is a common approach for reducing menopause-related vasomotor symptoms, it's not the only option. Lifestyle modifications, nutritional alterations, increased physical activity, and other pharmaceutical interventions are also utilized. Among the non-prescription options is Amberen, a dietary supplement marketed to reduce menopausal symptoms. This article delves into the ingredients of Amberen and examines the evidence surrounding its potential impact on weight loss during menopause.

What is Amberen?

Amberen is a nonhormonal dietary supplement marketed for menopausal symptom relief. It is a proprietary combination of several ingredients, including salts of succinic and fumaric acids, vitamin E, zinc, calcium, magnesium, L-glycine, and monosodium L-glutamate. The product's ingredients are separated into two capsules for stability: one white capsule with ammonium succinate (200 mg), and one orange capsule (200 mg) with calcium disuccinate, monosodium-L-glutamate, glycine, magnesium disuccinate, zinc difumarate, and tocopherol acetate. The supplement is typically taken once a day with a meal.

Clinical Trials and Pooled Data Analysis

Several randomized, double-blind clinical trials have investigated the effectiveness of succinate-based dietary supplements (SBDS), such as Amberen, in reducing menopause-related symptoms. While previous trials were relatively small, their effectiveness warranted further investigation. To assess the supplement's efficacy in symptomatic menopausal women more comprehensively, data from two identical trials were pooled and analyzed.

Study Design and Participants

The pooled analysis included raw data from two identical 90-day, randomized, multicenter, double-blinded, placebo-controlled clinical trials conducted in Russia. The trials enrolled symptomatic postmenopausal women between 42 and 60 years old, experiencing mild to moderate vasomotor and psychosomatic menopausal symptoms. These women had experienced 12 months of amenorrhea, as classified by the STRAW + 10 classification. The total number of subjects in the pooled analysis was 114 in the treatment group (SBDS) and 113 in the control group (placebo).

Data Collection and Evaluation

At the beginning of the study, researchers collected demographic data, general health information, and general and gynecological medical history from all subjects. Anthropometric measurements (height, body weight, and waist and hip circumferences) and vital signs were recorded, and subjects underwent general and gynecological exams. Standard laboratory evaluations included routine hematological and biochemical assays, urinalysis, mammograms, and ultrasounds of lower pelvic organs.

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To assess the SBDS's overall efficacy regarding vasomotor and psychosomatic climacteric symptoms, the Greene Climacteric Scale and State-Trait Anxiety Inventory (STAI) were used at baseline, 30th, 60th, and 90th days of the trials. Weight, BMI, waist and hip circumferences, and levels of FSH, LH, estradiol, leptin, and apolipoproteins A1 and B were evaluated as secondary endpoints. Weight measurements, waist and hip circumferences, and serum levels of FSH, LH, and estradiol were recorded at baseline and at the 30th, 60th, and 90th days of the trials. Levels for leptin and apolipoproteins A1 and B were evaluated at baseline and on the 90th day of the trials.

Ethical Considerations

All procedures performed in studies involving human participants adhered to the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. The protocols of both trials had been approved by a local IRB.

Statistical Analysis

Pooled data from the two studies were analyzed using MS Office 2010 and STATISTICA 12. Average (M), standard error (m), and deviation (σ), dispersion interval (minimum and maximum) were all calculated for quantitative parameters. Frequency of qualitative parameters was expressed in percent (%). All measured parameters were evaluated for normal distribution using Shapiro-Wilk, Lilliefors, and Kolmogorov-Smirnov tests. Comparative analysis of efficacy parameters (quantitative variables) was performed by comparing averages in the treatment and control groups. Comparison of averages for each parameter in the two groups was done using Mann-Whitney U test (nonparametric statistics) or Student's t-test (for normal distribution).

Key Findings of the Pooled Analysis

The pooled analysis of the two clinical trials revealed several significant findings:

Menopausal Symptom Relief: SBDS use resulted in significant improvements in several endpoints, including alleviation of 16 of 21 menopausal symptoms (p ≤ 0.05, Greene Scale) and a decrease in anxiety (p < 0.0001, State-Trait Anxiety Inventory) compared to placebo.
Weight Loss and Anthropometric Changes: Significant reductions were observed in weight, body mass index (BMI), and waist and hip circumferences in the supplement cohort. By the end of the study, the weight of subjects in the SBDS group decreased by 3.5 kg (4.57%), whereas, in the placebo group, body weight increased by 0.82 kg (1.07%), a significant difference (p=0.033). BMI was 28.56 kg/m2 ± 4.81 at study initiation and after treatment was 27.41 kg/m2 ± 4.18 kg/m2 (4.03% decrease) in the SBDS group. In the placebo group, baseline BMI was 28.34 kg/m2 ± 5.83 and after treatment was 28.64 kg/m2 ± 5.81 (1.06% increase). With regard to waist circumference, baseline was 88.49 cm ± 11.85 and after study completion was 85.14 cm ± 10.24 (3.79% decrease) in the SBDS group baseline compared to 86.7 cm ± 13.78 at study initiation and after treatment was 87.67 cm ± 13.76 cm in the placebo group (1.06% increase). By the end of the study, hip circumference decreased by 3.1 cm in the SBDS group (the measurements were 104.99 cm ± 11.32 at baseline and 101.89 cm ± 9.86 after the trial).
Hormonal Changes: Evaluation of physiological parameters showed a significant increase in serum estradiol levels compared to baseline (p < 0.0001) among users of the SBDS. Levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) decreased slightly in both groups, without significant differences between the groups.
Leptin Levels: Leptin levels decreased with statistical significance in the SBDS cohort compared to placebo (p=0.027). For those with initial leptin concentrations above the reference range, leptin decreased significantly in the SBDS group compared to the baseline (p < 0.0001) and to placebo (p=0.027).

Potential Mechanisms of Action

While the exact mechanisms by which Amberen may influence weight loss and menopausal symptoms are not fully understood, several possibilities exist:

Succinate and Fumaric Acids: These ingredients are involved in cellular energy production and may influence metabolic processes.
Leptin Regulation: Leptin is a hormone that regulates appetite and energy expenditure. The observed decrease in leptin levels in the SBDS group, particularly in those with elevated baseline levels, could potentially contribute to weight loss.
Estrogen Modulation: The increase in estradiol levels observed in the SBDS group may help alleviate certain menopausal symptoms, which in turn could indirectly influence weight management.

Considerations and Cautions

While the pooled analysis suggests potential benefits of Amberen for weight loss and menopausal symptom relief, it's important to consider the following:

Conflicts of Interest: The authors of the 2019 review of studies, which investigated the effectiveness of the product, disclosed conflicts of interest. One author was a paid consultant for Amberen, and the other three were involved in the original studies being reviewed. This raises concerns about potential bias in the interpretation of the results.
Limited Scientific Evidence: Despite the findings of the pooled analysis, there is still limited scientific evidence to support the effectiveness of Amberen's ingredients in relieving menopause symptoms or promoting weight loss.
Individual Variability: The effects of Amberen may vary from person to person. Some individuals may experience significant benefits, while others may not notice any difference.
Adverse Effects: While Amberen is generally considered safe, some users have reported adverse effects such as migraine headaches, bloating, and constipation.
Lack of FDA Approval: Amberen is a dietary supplement and has not been approved by the Food and Drug Administration (FDA). This means that its safety and efficacy have not been rigorously evaluated by the FDA.
Ingredient Disclosure: While supplement labels are required to list ingredients in order of predominance by weight, the exact amount of each ingredient in Amberen's proprietary blend isn’t disclosed (except for the vitamin E at 5.04 mg per serving).

Alternative Approaches to Menopause Management

It's important to remember that Amberen is just one of many approaches to managing menopause symptoms and weight. Other strategies include:

Hormone Therapy (HT): HT remains the most effective approach for managing menopausal symptoms.
Lifestyle Modifications: Lifestyle changes such as diet, exercise, and stress management can also play a significant role in alleviating symptoms and promoting overall health.
Natural Remedies: Some natural remedies, such as maca root, black cohosh, flaxseed, red clover, and evening primrose oil, have been shown to help quell hot flashes. Plant extracts like kava and DIM may also be beneficial.
Prescription Medications: Several prescription medications are available to treat specific menopause symptoms, such as hot flashes, vaginal dryness, and sleep disturbances.

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