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Effect of a Hop Extract Standardized in 8-Prenylnaringenin on Bone Health and Gut Microbiome in Postmenopausal Women with Osteopenia: A One-Year Randomized, Double-Blind, Placebo-Controlled Trial.
Lecomte, M, Tomassi, D, Rizzoli, R, Tenon, M, Berton, T, Harney, S, Fança-Berthon, P
Nutrients. 2023;15(12)
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Osteoporosis is a bone condition characterized by weakened and brittle bones, leading to an increased risk of fractures. Oestrogens play a vital role in maintaining bone health, whereby oestrogen deficiency elevates the risk of osteoporosis and fractures, particularly in menopausal women due to the decline in oestrogen levels. Phytoestrogens, plant-derived compounds capable of interacting with human oestrogen receptors, have presented an intriguing non-pharmaceutical avenue for preventing bone loss. Other phytoestrogens have received some attention in the field, however, limited human research exists on prenylflavonoids, a phytoestrogens found in hops (Humulus lupulus). This randomized, double-blinded, placebo-controlled trial aimed to investigate the effects of a year-long supplementation of standardised hop extract (8-PN) Lifenol® on bone mineral density in postmenopausal women. Additionally, the study explored potential mechanisms, particularly focusing on changes in gut bacteria. Notably, gut bacteria play a role in bone metabolism and the pathogenesis of osteoporosis. They are also, along with the liver, responsible for converting hops phenols into active phytoestrogenic compounds. The trial was completed by 95 postmenopausal, women with Osteopenia aged 50 to 85. They all received calcium and vitamin D3 tablets in addition either a hop extract (100mcg) or a placebo for 48 weeks. Changes were monitored using DXA scans for bone mineral density (BMD) and bone metabolism, blood samples for markers for bone health, a quality of life questionnaire, gut microbiome testing, and tests for short-chain fatty acid (SCFA) levels. In conclusion, the intake of hop extract confirmed a previously observed trend of a slight increase in total bone mineral density (BMD), in addition to the benefits linked to calcium and vitamin D supplementation. Although there were no significant changes in the composition of gut bacteria and SCFA levels, the hop extract candidates had a higher abundance of specific genera associated with total body BMD, suggesting a potential positive impact. Larger studies are required to validate these findings.
Abstract
Estrogen deficiency increases the risk of osteoporosis and fracture. The aim of this study was to investigate whether a hop extract standardized in 8-prenylnaringenin (8-PN), a potent phytoestrogen, could improve bone status of osteopenic women and to explore the gut microbiome roles in this effect. In this double-blind, placebo-controlled, randomized trial, 100 postmenopausal, osteopenic women were supplemented with calcium and vitamin D3 (CaD) tablets and either a hop extract (HE) standardized in 8-PN (n = 50) or a placebo (n = 50) for 48 weeks. Bone mineral density (BMD) and bone metabolism were assessed by DXA measurements and plasma bone biomarkers, respectively. Participant's quality of life (SF-36), gut microbiome composition, and short-chain fatty acid (SCFA) levels were also investigated. In addition to the CaD supplements, 48 weeks of HE supplementation increased total body BMD (1.8 ± 0.4% vs. baseline, p < 0.0001; 1.0 ± 0.6% vs. placebo, p = 0.08), with a higher proportion of women experiencing an increase ≥1% compared to placebo (odds ratio: 2.41 ± 1.07, p < 0.05). An increase in the SF-36 physical functioning score was observed with HE versus placebo (p = 0.05). Gut microbiome α-diversity and SCFA levels did not differ between groups. However, a higher abundance of genera Turicibacter and Shigella was observed in the HE group; both genera have been previously identified as associated with total body BMD. These results suggest that an 8-PN standardized hop extract could beneficially impact bone health of postmenopausal women with osteopenia.
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Muscle Mass Changes After Daily Consumption of Protein Mix Supplemented With Vitamin D in Adults Over 50 Years of Age: Subgroup Analysis According to the Serum 25(OH)D Levels of a Randomized Controlled Trial.
Kang, Y, Kim, N, Lee, Y, An, X, Chung, YS, Park, YK
Clinical nutrition research. 2023;12(3):184-198
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Sarcopenia is an age-related decrease in muscle mass and strength and increases the risk of falls and death. Protein intake and vitamin D are important for the maintenance of muscle mass, and the amino acid leucine plays a role in the regulation of muscle protein turnover. The aim of this 12-week double-blind, randomised, placebo-controlled trial was to evaluate the efficacy of a supplement containing protein, vitamin D, leucine and calcium for maintaining muscle mass, strength and physical functioning in healthy Koreans aged 50-80 years. Increases in muscle mass were seen in those with low vitamin D levels (< 30 ng/ml) but not in those with higher vitamin D levels. No differences were observed in muscle strength and physical functioning. The authors concluded that a supplement containing protein, including high levels of leucine, vitamin D and calcium may be of benefit for muscle mass to middle-aged and older adults with low vitamin D levels.
Expert Review
Conflicts of interest:
None
Take Home Message:
- Consider supplementing protein in combination with leucine, vitamin D and calcium in middle-aged or older adults with insufficient vitamin D levels for prevention of sarcopenia.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
- Sarcopenia increases the risk of falls and death
- Protein and vitamin D are important for maintaining muscle mass whilst leucine is involved in regulating muscle protein turnover
- The aim of this study was to evaluate the effects of a supplement containing protein, vitamin D, leucine and calcium on muscle mass, physical functioning, muscle strength, and physical ability in middle-aged and older adults.
Methods
- Double-blind, randomised, placebo-controlled trial, with a duration of 12 weeks. Included 120 healthy Koreans aged 50-80 years
- Participants were assigned to “insufficient” subgroup if vitamin D levels were <30ng/ml and to the “sufficient” subgroup if vitamin D was 30ng/ml or higher
- Intervention: 2.5g powder (containing 20g protein (90% milk/10% soya, incl. 3g leucine), 800 IU vitamin D, 300 mg calcium) mixed into beverage of choice twice a day. Control: isocaloric placebo powder
- Primary outcome: Muscle mass determined by dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis (BIA)
- Secondary outcomes: Muscle strength (femoral muscle and grip strength); physical functioning (short physical performance battery (SPPB), International Physical Activity Questionnaire (IPAQ)).
Results
- At baseline, age of participants in the “sufficient” intervention subgroup was higher than that of the “sufficient” control subgroup (p=0.02)
- Increase in vitamin D levels in intervention group relative to control group, in both sufficient and insufficient subgroups (difference in changes between groups 11.5 ng/ml and 13.9 ng/ml, respectively, both p=0.00)
- No difference in change in muscle index as measured by DXA between groups
- In the “insufficient” subgroup, BIA increases in muscle mass were seen when normalised by height (p=0.037) and weight (p=0.05)
- No differences in changes in physical functioning or muscle strength between groups.
Conclusion
- The authors conclude that a supplement containing protein, with high levels of leucine, vitamin D and calcium may be of benefit for muscle mass to middle-aged and older adults with insufficient vitamin D levels.
Clinical practice applications:
- Middle-aged and older adults with insufficient vitamin D levels may gain muscle mass through supplementation of protein, leucine, vitamin D and calcium
- Middle-age and older adults with sufficient vitamin D levels do not appear to benefit from the same intervention.
Considerations for future research:
- Longer-term studies may help identify whether increases in muscle mass lead to improved physical functioning over time
- A study combining supplementation and exercise may help identify additive or synergistic effects.
Abstract
UNLABELLED Early prevention of sarcopenia can be an important strategy for muscle maintenance, but most studies target subjects at slightly pre-sarcopenic state. Our previous paper describes the effect of protein supplements rich in leucine and vitamin D on muscle condition, and in this paper, we performed a sub-analysis to evaluate who benefitted the most in terms of improvement in muscle health. A 12-week randomized clinical trial of 120 healthy adults (aged 50 to 80) assigned to an intervention group (n = 60) or control group (n = 60) were analyzed. Subjects in the intervention group received, twice per day, a protein supplement containing (per serving) 800 IU of vitamin D, 20 g of protein (3 g of total leucine), 300 mg of calcium, 1.1 g of fat, and 2.5 g of carbohydrate. The subjects were classified into 'insufficient' and 'sufficient' groups at 25-hydroxyvitamin D (25[OH]D) value of 30 ng/mL. The skeletal muscle mass index normalized to the square of the skeletal muscle mass (SMM) height (kg/m2) increased significantly in the 'insufficient group' difference value of change between weeks 0 and 12 (Δ1.07 ± 2.20; p = 0.037). The SMM normalized by body weight (kg/kg, %) was higher, but not significantly, in the insufficient group (Δ0.38 ± 0.69; p = 0.050). For people with insufficient (serum 25[OH]D), supplemental intake of protein and vitamin D, calcium, and leucine and adequate energy intake increases muscle mass in middle-aged and older adults and would be likely to exert a beneficial effect on muscle health. TRIAL REGISTRATION Clinical Research Information Service Identifier: KCT0005111.
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Role of Calcium and Low-Fat Dairy Foods in Weight-Loss Outcomes Revisited: Results from the Randomized Trial of Effects on Bone and Body Composition in Overweight/Obese Postmenopausal Women.
Ilich, JZ, Kelly, OJ, Liu, PY, Shin, H, Kim, Y, Chi, Y, Wickrama, KKAS, Colic-Baric, I
Nutrients. 2019;11(5)
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A woman’s menopausal years are believed to bring about weight gain due to various biological mechanisms, such as depletion of oestrogen. Many women undertake weight loss diets, in an attempt to control the weight gain, and although weight loss can reduce the risk factors for metabolic and cardiovascular disease etc, it can also lead to accelerated loss bone density and muscle mass. The objective of this study was to investigate whether by complementing a low-calorie diet with 4 to 5 servings of low-fat dairy foods per day and/or supplementing with calcium and vitamin D supplements would aid weight loss and preserve either/both bone and muscle mass. The study was conducted on 189 early postmenopausal, obese women. It was a randomized, placebo-controlled clinical trial conducted over 6 months. Researchers found that results were better for the participants on the low-fat dairy foods and those supplementing with calcium and vitamin D when compared to the placebo group (who only had placebo pills). They suggest that when embarking on a weight loss program it is beneficial to include 4 to 5 servings of low-fat dairy foods each day and take calcium and vitamin D supplements will have a positive impact on weight loss, bone density and muscle mass in post-menopausal women.
Abstract
Several studies have investigated the possibility of dairy foods and calcium (Ca) mediating weight and body composition, but a consensus has not been reached. We aimed to investigate weight-loss-related outcomes during intervention with low-fat dairy foods or Ca + vitamin D supplements, both as complements to hypocaloric diets. Overweight/obese Caucasian, early-postmenopausal women (n = 135) were recruited for a 6 month energy-restricted weight loss study complemented with either low-fat dairy foods (D; 4-5 servings/day), or Ca + vitamin D supplements (S); both to amount a total of ~1500 mg/day and 600 IU/day of Ca and vitamin D, respectively, or placebo pills (C). Bone mineral density (BMD) and lean and fat tissue were measured by Lunar iDXA. Serum and urinary markers of bone turnover were analyzed. Diet and physical activity were assessed with 3-day records. Participants on average lost ~4%, ~3%, and ~2% of body weight, fat, and lean tissue, respectively. The significantly better outcomes were noticed in participants in the D group regarding body composition (fat loss/lean tissue preservation) and in participants in the S group regarding the BMD outcomes, compared to those in the C group. Therefore, increasing low-fat dairy foods to 4-5 servings/day and/or increasing Ca & vitamin D intake by supplements (in those who are at the borderline dietary intake) may be beneficial for weight loss/maintenance and may lead to more favorable bone and body composition outcomes in postmenopausal women during moderate weight loss.
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Vegetarian-style dietary pattern during adolescence has long-term positive impact on bone from adolescence to young adulthood: a longitudinal study.
Movassagh, EZ, Baxter-Jones, ADG, Kontulainen, S, Whiting, S, Szafron, M, Vatanparast, H
Nutrition journal. 2018;17(1):36
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Bone mass attained at the end of adolescence is an important determinant of later osteoporosis risk. Little is known about the influence of dietary patterns on bones during adolescence and their potential long-term implications into adulthood. The aim of this study was to examine the effect of dietary patterns on bone change from adolescence to young adulthood in 125 adolescents and 115 young adults. Bone mineral content and bone mineral density were measured, and dietary intake from multiple 24-hour recalls were collected. Five dietary patterns were found including vegetarian style, western-like, high-fat high protein, mixed and snack. This study found that a vegetarian style diet during adolescence is positively associated with bone health. Based on these results, the authors conclude bone accrual in adolescence can be carried into young adulthood, and suggest further studies are needed to generalise these results to wider populations.
Abstract
BACKGROUND The amount of bone accrued during adolescence is an important determinant of later osteoporosis risk. Little is known about the influence of dietary patterns (DPs) on the bone during adolescence and their potential long-term implications into adulthood. We examined the role of adolescent DPs on adolescent and young adult bone and change in DPs from adolescence to young adulthood. METHODS We recruited participants from the Saskatchewan Pediatric Bone Mineral Accrual Study (1991-2011). Data from 125 participants (53 females) for adolescent analysis (age 12.7 ± 2 years) and 115 participants (51 females) for adult analysis (age 28.2 ± 3 years) were included. Bone mineral content (BMC) and areal bone mineral density (aBMD) of total body (TB), femoral neck (FN) and lumbar spine (LS) were measured using dual-energy X-ray absorptiometry. Adolescent dietary intake data from multiple 24-h recalls were summarized into 25 food group intakes and were used in the principal component analysis to derive DPs during adolescence. Associations between adolescent DPs and adolescent or adult BMC/BMD were analyzed using multiple linear regression and multivariate analysis of covariance while adjusting for sex, age, the age of peak height velocity, height, weight, physical activity and total energy intake. Generalized estimating equations were used for tracking DPs. RESULTS We derived five DPs including "Vegetarian-style", "Western-like", "High-fat, high-protein", "Mixed" and "Snack" DPs. The "Vegetarian-style" DP was a positive independent predictor of adolescent TBBMC, and adult TBBMC, TBaBMD (P < 0.05). Mean adolescent TBaBMD and young adult TBBMC, TBaBMD, FNBMC and FNaBMD were 5%, 8.5%, 6%, 10.6% and 9% higher, respectively, in third quartile of "Vegetarian-style" DP compared to first quartile (P < 0.05). We found a moderate tracking (0.47-0.63, P < 0.001) in DP scores at individual levels from adolescence to adulthood. There were an upward trend in adherence to "Vegetarian-style" DP and an downward trend in adherence to "High-fat, high-protein" DP from adolescence to young adulthood (P < 0.01). CONCLUSION A "Vegetarian-style" DP rich in dark green vegetables, eggs, non-refined grains, 100% fruit juice, legumes/nuts/seeds, added fats, fruits and low-fat milk during adolescence is positively associated with bone health.
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Physiologic and behavioral indicators of energy deficiency in female adolescent runners with elevated bone turnover.
Barrack, MT, Van Loan, MD, Rauh, MJ, Nichols, JF
The American journal of clinical nutrition. 2010;92(3):652-9
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Young female runners are more likely to have a low bone mass for their age. It is thought that this might be partly due to them using more energy (calories) than they consume. This study looked at the relationship between nutrition intake and biomarkers of bone turnover in young female runners. Participants were competitive cross-country runners, aged 14-17. The girls ate their usual diet and kept a food diary for a week, to allow the researchers to analyse their nutritional intakes. Runners that had an elevated bone turnover consumed significantly less calories and calcium than the runners with a normal bone turnover. They were also more likely to have a lower body mass, fewer menstrual cycles, lower oestrogen and vitamin D levels, lower BMI and lower bone mass. The authors concluded that nutritional support to increase energy and calcium intake, and vitamin D levels may improve bone growth in young female runners.
Abstract
BACKGROUND Female adolescent runners have an elevated prevalence of low bone mass for agemdashan outcome that may be partially due to inadequate energy intake. OBJECTIVE The objective was to evaluate diet, menstrual history, serum hormone concentrations, and bone mass in female adolescent runners with normal or abnormal bone turnover. DESIGN Thirty-nine cross-country runners (age: 15.7 plusmn 0.2 y) participated in the study, which included a 7-d dietary assessment with the use of a food record and daily 24-h dietary recalls; serum measures of insulin-like growth factor I, estradiol, leptin, parathyroid hormone, progesterone, triiodothyronine, 25-hydroxycholecalciferol, bone-specific alkaline phosphatase (BAP), and cross-linked C-telopeptides of type I collagen (CTX); an evaluation of height, weight, bone mass, and body composition with the use of dual-energy X-ray absorptiometry; and a questionnaire to assess menses and sports participation. Age- and sex-specific BAP and CTX concentrations of at least the 97th percentile and no greater than the third percentile, respectively, were considered abnormal. RESULTS All abnormal BAP and CTX concentrations fell within the elevated ( ge 97%) range. Runners with an elevated bone turnover (EBT) (n = 13) had a lower body mass, fewer menstrual cycles in the past year, lower estradiol and 25-hydroxycholecalciferol concentrations, and a higher prevalence of body mass index lt 10% for age, vitamin D insufficiency, amenorrhea, and low bone mass. Girls with EBT consumed less than the recommended amounts of energy and had a higher prevalence of consuming lt 1300 mg Ca than did those with normal bone turnover. CONCLUSIONS Runners with EBT had a profile consistent with energy deficiency. Nutritional support to increase energy, calcium intake, and 25-hydroxycholecalciferol concentrations may improve bone mineral accrual in young runners with EBT. This trial was registered at clinicaltrials.gov as NCT01059968.