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Effect of Human Ration on Weight Loss and Bone Health in Overweight Women

Effect of Human Ration in Weight Loss and in Bone Health in Overweight Women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4qpj2r
Enrollment
Unknown
Registered
2013-04-02
Start date
2011-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight loss. Organic mineral homeostase. Bone health.

Interventions

Study led with female subjects enrolled in a Family Health Strategy in Viçosa, Minas Gerais. The minimum sample size of 20 individuals was calculated based on the study of Mera et al. (1998), based on
Dietary supplement
SP6.051.227

Sponsors

Universidade Federal de Viçosa
Lead Sponsor
Universidade Federal de Viçosa
Collaborator

Eligibility

Sex/Gender
Female
Age
24 Years to 45 Years

Inclusion criteria

Inclusion criteria: Female gender. IMC higher than 25 and less than 34.9 kg/m2 and age between 24 and 45 years.

Exclusion criteria

Exclusion criteria: Pregnant or breastfeeding women. Menopausal women or who underwent removal of the uterus. Which used anti-inflammatories. Who presented intolerance or allergy to any ingredient in the product. Which drink´s alcohol or smokes. Who were using the drug for inhibiting appetite. Antidepressants or whatever to interfere in bone mineral metabolism (bisphosphonates, anabolic steroids, calcitonin, fluoride, hormone replacement therapy, androgens, calcium, vitamin D, thiazide diuretics, and statins). Women with a history of conditions or diseases associated with changes in bone mass such as kidney disease (cholelithiasis, chronic renal failure), gastrointestinal disease (celiac disease, chronic liver disease, malabsorption syndrome, gastrectomy or colectomy). History of endocrine disease (hyperparathyroidism, hyperthyroidism or hypothyroidism). Fractures in the last six months. Which had shown restraint for more than two months and showed fluctuations in body weight greater than 5% in the two months before recruitment.

Design outcomes

Primary

MeasureTime frame
Anthropometric and blood pressure evaluation: body weight, height, waist circumference and blood pressure level assessment. Body composition: measurement of body composition (lean and fat). Bone health: measurement of bone mineral content and serum biochemical bone metabolism markers. Iron and zinc bioavailability: biochemical measurements of serum iron, complete blood count, serum ferritin, plasma zinc and erythrocyte.;There were modifications in anthropometric measures weight and waist circumference, but there were no differences between treatments. There was no change in blood pressure level. Body composition and bone health showed no significant changes. The group that consumed "Human Ration" showed improvement in hemoglobin concentration (P = 0.0001) and were not observed any loss in relation to the absorption of zinc. Erythrocyte zinc and BMI (body mass index) showed a negative correlation r = -0.5123 P = 0.0005.

Secondary

MeasureTime frame
Food consumption: assessment of dietary intake by 3 day food record and Health eating index. Assessment of physical activity: International Questinário Physical Activity (IPAQ).;Volunteers who consumed "Human Ration" showed a significant increase in iron intake (P = 0.0002), phosphorus (P < 0.0001), zinc (P < 0.0001) and vitamin E (P = 0.001). There were no changes in physical activity level of the volunteers.

Countries

Brazil

Contacts

Public ContactHércia Martino

Universidade Federal de Viçosa

hercia@ufv.br+55(31)3899-3742

Outcome results

None listed

Source: REBEC (via WHO ICTRP)